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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04109066




Registration number
NCT04109066
Ethics application status
Date submitted
27/09/2019
Date registered
30/09/2019
Date last updated
12/03/2024

Titles & IDs
Public title
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Scientific title
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Secondary ID [1] 0 0
CA209-7FL
Universal Trial Number (UTN)
Trial acronym
CheckMate 7FL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Drugs - paclitaxel (PTX)
Other interventions - nivolumab placebo
Treatment: Drugs - anthracycline
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - Endocrine Therapy
Treatment: Surgery - Surgery

Experimental: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET - Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice

Placebo comparator: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET - Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice


Treatment: Other: nivolumab
Specified Dose on Specified days

Treatment: Drugs: paclitaxel (PTX)
Specified dose on Specified days

Other interventions: nivolumab placebo
Specified dose on Specified days

Treatment: Drugs: anthracycline
Specified dose on Specified days

Treatment: Drugs: cyclophosphamide
Specified dose on Specified days

Treatment: Drugs: Endocrine Therapy
Variable endocrine therapy of investigators choice

Treatment: Surgery: Surgery
Surgery for breast cancer
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological Complete Response (pCR) Rate
Timepoint [1] 0 0
Up to approximately 37 months
Secondary outcome [1] 0 0
Pathological Complete Response (pCR) Rate (PD-L1 >=1%)
Timepoint [1] 0 0
Up to approximately 37 months
Secondary outcome [2] 0 0
Number of Participants With Residual Cancer Burden (RCB)
Timepoint [2] 0 0
Up to approximately 37 months
Secondary outcome [3] 0 0
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
Timepoint [3] 0 0
Up to approximately 37 months
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
Secondary outcome [6] 0 0
Number of Participants Who Died
Timepoint [6] 0 0
Up to approximately 37 months

Eligibility
Key inclusion criteria
* Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.
* Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines.
* Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.
* Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%
* Must agree to provide primary breast tumor tissue at baseline and at surgery
* Must be deemed eligible for surgery
* Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial
* Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment
* Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association
* History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time
* Definitive clinical or radiologic evidence of metastatic disease
* Multicentric BC (the presence of > 1 tumor in different quadrants of the breast)
* Bilateral invasive BC

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2023
Sample size
Target
Accrual to date
Final
521
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0071 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0069 - Port Macquarie
Recruitment hospital [3] 0 0
Local Institution - 0072 - Herston
Recruitment hospital [4] 0 0
Local Institution - 0067 - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - 0066 - Clayton
Recruitment hospital [6] 0 0
Local Institution - 0142 - Clayton
Recruitment hospital [7] 0 0
Local Institution - 0070 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0068 - North Ballarat
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
33500 - North Ballarat
Recruitment outside Australia
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United States of America
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Alabama
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
Trial website
https://clinicaltrials.gov/study/NCT04109066
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04109066