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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06312176
Registration number
NCT06312176
Ethics application status
Date submitted
7/03/2024
Date registered
15/03/2024
Date last updated
14/07/2025
Titles & IDs
Public title
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
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Scientific title
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
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Secondary ID [1]
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MK-2870-010
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Secondary ID [2]
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2870-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab tirumotecan
Treatment: Other - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Capecitabine
Treatment: Drugs - Liposomal doxorubicin
Experimental: Arm A: Sacituzumab tirumotecan - Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan - Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).
Active comparator: Arm C: Treatment of Physician's Choice (TPC) - At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
Treatment: Drugs: Sacituzumab tirumotecan
IV infusion
Treatment: Other: Pembrolizumab
IV infusion
Treatment: Drugs: Paclitaxel
IV infusion
Treatment: Drugs: Nab-paclitaxel
IV infusion
Treatment: Drugs: Capecitabine
oral tablet
Treatment: Drugs: Liposomal doxorubicin
IV infusion
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
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Timepoint [1]
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Up to ~38 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [1]
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Up to ~77 months
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Secondary outcome [2]
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Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
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Assessment method [2]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
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Timepoint [2]
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Up to ~57 months
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [3]
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Up to ~57 months
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [4]
0
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Up to ~57 months
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Secondary outcome [5]
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Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [5]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
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Timepoint [5]
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Baseline and up to ~77 months
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Secondary outcome [6]
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Change from baseline in physical functioning score, on the EORTC QLQ-C30
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Assessment method [6]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.
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Timepoint [6]
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Baseline and up to ~77 months
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Secondary outcome [7]
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Change from baseline in emotional functioning score, on the EORTC QLQ-C30
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Assessment method [7]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning.
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Timepoint [7]
0
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Baseline and up to ~77 months
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Secondary outcome [8]
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Change from baseline in fatigue score, on the EORTC QLQ-C30
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Assessment method [8]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
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Timepoint [8]
0
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Baseline and up to ~77 months
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Secondary outcome [9]
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Change from baseline in diarrhea score, on the EORTC QLQ-C30
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Assessment method [9]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
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Timepoint [9]
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0
Baseline and up to ~77 months
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Secondary outcome [10]
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Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
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Assessment method [10]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in global health status/quality of life combined score.
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Timepoint [10]
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Up to ~77 months
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Secondary outcome [11]
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TTD in physical functioning score, on the EORTC QLQ-C30
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Assessment method [11]
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0
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the physical functioning score.
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Timepoint [11]
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0
Up to ~77 months
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Secondary outcome [12]
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TTD in emotional functioning score, on the EORTC QLQ-C30
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Assessment method [12]
0
0
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning. TD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the emotional functioning score.
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Timepoint [12]
0
0
Up to ~77 months
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Secondary outcome [13]
0
0
TTD in fatigue score, on the EORTC QLQ-C30
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Assessment method [13]
0
0
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the fatigue score.
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Timepoint [13]
0
0
Up to ~77 months
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Secondary outcome [14]
0
0
TTD in diarrhea score, on the EORTC QLQ-C30
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Assessment method [14]
0
0
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question about their diarrhea are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the diarrhea score.
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Timepoint [14]
0
0
Up to ~77 months
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Secondary outcome [15]
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Number of participants who experience one or more adverse events (AEs)
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Assessment method [15]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [15]
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Up to ~77 months
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Secondary outcome [16]
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Number of participants who discontinue study treatment due to an AE
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Assessment method [16]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [16]
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Up to ~77 months
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Eligibility
Key inclusion criteria
* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has breast cancer amenable to treatment with curative intent
* Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
* Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/04/2031
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Actual
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Sample size
Target
1200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Macquarie University-MQ Health Clinical Trials Unit ( Site 2002) - Macquarie University
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Recruitment hospital [2]
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Westmead Hospital ( Site 2000) - Westmead
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Recruitment hospital [3]
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Frankston Hospital-Oncology and Haematology ( Site 2003) - Frankston
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Recruitment hospital [4]
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Fiona Stanley Hospital-Medical Oncology ( Site 2004) - Murdoch
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Maryland
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Missouri
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Argentina
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Caba
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Argentina
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Santa Fe
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Argentina
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Buenos Aires
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Cordoba
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Argentina
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La Rioja
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Bruxelles-Capitale, Region De
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Praha 5
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Attiki
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Thessalia
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Hksar
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Shatin
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Csongrad
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Somogy
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Zala
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Hungary
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Debrecen
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India
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State/province [68]
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Delhi
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India
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Maharashtra
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Ireland
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State/province [70]
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Cork
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Ireland
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Dublin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Italy
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Forli-Cesena
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Italy
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Friuli-Venezia Giulia
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Bologna
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Italy
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Genova
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Italy
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Roma
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Japan
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Aichi
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Fukushima
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Kagoshima
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Japan
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Kumamoto
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Country [96]
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Japan
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State/province [96]
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Kyoto
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Japan
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State/province [97]
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Okayama
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Korea, Republic of
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Seoul
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Malaysia
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Johor
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Malaysia
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Sarawak
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Malaysia
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Kuala Lumpur
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Overijssel
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Netherlands
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Utrecht
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New Zealand
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Auckland
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Peru
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Ariqipa
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Peru
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Lima
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Peru
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Muni Metro De Lima
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Podkarpackie
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Poland
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State/province [118]
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Podlaskie
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Poland
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State/province [119]
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Pomorskie
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Country [120]
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Poland
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State/province [120]
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Slaskie
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Poland
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Swietokrzyskie
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Poland
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Zachodniopomorskie
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Portugal
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State/province [123]
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Lisboa
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Portugal
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Porto
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Puerto Rico
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State/province [125]
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Hato Rey
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Puerto Rico
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San Juan
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Romania
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State/province [127]
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Bucuresti
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Romania
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Cluj
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Singapore
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Central Singapore
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Singapore
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North East
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South Africa
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Eastern Cape
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Country [132]
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South Africa
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Gauteng
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Country [133]
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South Africa
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Western Cape
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Spain
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Madrid
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Spain
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Valenciana, Comunitat
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Sevilla
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Stockholms Lan
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Sweden
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Uppsala Lan
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Sweden
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Switzerland
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Basel-Stadt
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Switzerland
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Berne
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Kaohsiung
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Tainan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Adana
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Turkey
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Samsun
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United Kingdom
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Derry And Strabane
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United Kingdom
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England
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United Kingdom
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London, City Of
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United Kingdom
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Blackpool
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
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Trial website
https://clinicaltrials.gov/study/NCT06312176
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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0
Toll Free Number
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Address
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0
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0
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Phone
0
0
1-888-577-8839
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06312176
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