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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06380751
Registration number
NCT06380751
Ethics application status
Date submitted
25/03/2024
Date registered
24/04/2024
Date last updated
17/06/2025
Titles & IDs
Public title
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
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Scientific title
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
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Secondary ID [1]
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0
D9722C00001
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Universal Trial Number (UTN)
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Trial acronym
EvoPAR-BR01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer
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Condition category
Condition code
Cancer
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0
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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 - Saruparib (AZD5305)
Treatment: Drugs - Camizestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Ribociclib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Treatment: Drugs - Exemestane
Experimental: Arm 1: saruparib (AZD5305) plus camizestrant - participants will receive saruparib (AZD5305) orally and camizestrant orally
Active comparator: Arm 2: Physician's choice CDK4/6i plus physician's choice ET - agents are indicated below and should follow local guidelines:
* Physician's Choice CDK4/6i:
* abemaciclib orally, or
* ribociclib orally, or
* palbociclib orally.
* Physician's Choice ET:
* fulvestrant intramuscularly, or
* One of the following AIs:
* letrozole orally, or
* anastrozole orally, or
* exemestane orally
Experimental: Arm 3: Physician's choice CDK4/6i plus camizestrant - participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines
Treatment: Drugs: Saruparib (AZD5305)
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Treatment: Drugs: Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Treatment: Drugs: Abemaciclib
CDK4/6 Inhibitor
Treatment: Drugs: Ribociclib
CDK4/6 Inhibitor
Treatment: Drugs: Palbociclib
CDK 4/6 Inhibitor
Treatment: Drugs: Fulvestrant
Endocrine Therapy
Treatment: Drugs: Letrozole
Endorcine Therapy
Treatment: Drugs: Anastrozole
Endocrine Therapy
Treatment: Drugs: Exemestane
Endocrine Therapy
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Intervention code [1]
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Treatment: Drugs
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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
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Assessment method [1]
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PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
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Timepoint [1]
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Up to approximately 59 months
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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OS is defined as the time from randomisation until the date of death due to any cause.
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Timepoint [1]
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Up to approximately 88 months
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Secondary outcome [2]
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Progression Free Survival 2
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Assessment method [2]
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PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
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Timepoint [2]
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Up to approximately 59 months
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Secondary outcome [3]
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Time to chemotherapy
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Assessment method [3]
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Time to chemotherapy is defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).
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Timepoint [3]
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Up to approximately 59 months
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Secondary outcome [4]
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Objective Response Rate
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Assessment method [4]
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ORR is defined as the proportion of participants who have a complete or parial response, as determined by BICR per RECIST v1.1.
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Timepoint [4]
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Up to approximately 59 months
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Secondary outcome [5]
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Duration of Response
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Assessment method [5]
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DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
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Timepoint [5]
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Up to approximately 59 months
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Secondary outcome [6]
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Participant-reported tolerability
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Assessment method [6]
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Proportion of all dosed participants reporting different levels of severity of diarrhoea as measured by the diarrhoea single item (EORTC IL237/IL239/IL240) and different levels of severity of abdominal pain as measured by the abdominal pain single item (EORTC IL237/IL239/IL240).
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Timepoint [6]
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Up to approximately 59 months
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Secondary outcome [7]
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Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)
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Assessment method [7]
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This scale includes 2 items asking participants to report overall health and overall quality of life in the past week. Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent. Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
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Timepoint [7]
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Up to approximately 59 months
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Secondary outcome [8]
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Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)
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Assessment method [8]
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This scale includes 2 items asking participants to report overall health and overall quality of life in the past week. Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent. Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
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Timepoint [8]
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Up to approximately 59 months
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Secondary outcome [9]
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Plasma concentrations of saruparib (AZD5305)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 59 months
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Secondary outcome [10]
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Plasma concentrations of camizestrant
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Assessment method [10]
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Timepoint [10]
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Up to approximately 59 months
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Secondary outcome [11]
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Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
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Assessment method [11]
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Samples will be tested by a CDx to confirm BRCA1/2 and PALB2 gene mutation status
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Timepoint [11]
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Up to approximately 59 months
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Eligibility
Key inclusion criteria
* Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
* FFPE tumour tissue from each participant
* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
* Adequate organ and marrow function
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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
* Participants with history of MDS/AML or with features suggestive of MDS/AML
* Participants with any known predisposition to bleeding
* Any history of persisting severe cytopenia
* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
* History of another primary malignancy
* Persistent toxicities (CTCAE Grade = 2) caused by previous anti-cancer therapy excluding alopecia
* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
* Evidence of active and uncontrolled hepatitis B and/or hepatitis C
* Evidence of active and uncontrolled HIV infection
* Active tuberculosis infection
* Cardiac criteria, including history of arrythmia and cardiovascular disease
* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation
* Prior treatment within 28 days with blood product support or growth factor support
* Any systemic concurrent anti-cancer treatment
* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
1. Strong and moderate CYP3A4 inducers/inhibitors
2. Sensitive CYP2B6 substrates
3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
* Systemic use of atropine
* The following exclusion criteria apply to treatments administered for early breast cancer:
1. Disease progression = 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
2. Disease progression = 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
3. Disease progression = 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
4. Disease progression = 1 year (365 days) from the last dose of an oral SERD including camizestrant.
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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
1/08/2024
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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
18/10/2030
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Research Site - Malvern
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Research Site - Melbourne
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2139 - Darlinghurst
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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VIC 3000 - Melbourne
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Recruitment outside Australia
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France
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India
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India
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India
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India
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India
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Surat
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India
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Reggio Emilia
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Italy
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Rome
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Italy
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Rozzano
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Shinagawa-ku
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Daegu
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Bellavista
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Peru
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Jesus Maria, Lima
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Peru
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Lima
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Biala Podlaska
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Warszawa
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Lódz
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Coimbra
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Portugal
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Portugal
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Matosinhos
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Portugal
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Porto
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Portugal
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Vila Real
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Barcelona
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Granada
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L'Hospitalet de Llobregat
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Madrid
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Malaga
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Pamplona
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Sevilla
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Valencia
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Taiwan
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New Taipei City
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Taichung
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Taipei
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Bangkok
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Dusit
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Hat Yai
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Ratchathewi
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Adapazari
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Istanbul
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Turkey
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Kayseri
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Çankaya
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United Kingdom
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Cambridge
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United Kingdom
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Guildford
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United Kingdom
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London
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United Kingdom
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Oxford
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Taunton
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
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Trial website
https://clinicaltrials.gov/study/NCT06380751
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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Phone
0
0
1-877-240-9479
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Fax
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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/NCT06380751
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