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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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CA209-7FL
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 7FL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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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(has expanded access)
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Description of intervention(s) / exposure
Other interventions - 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
Other interventions: 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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Treatment: Surgery
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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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Pathological Complete Response (pCR) Rate
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Assessment method [1]
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pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
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Timepoint [1]
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Up to approximately 37 months
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Secondary outcome [1]
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Pathological Complete Response (pCR) Rate (PD-L1 >=1%)
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Assessment method [1]
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pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
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Timepoint [1]
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Up to approximately 37 months
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Secondary outcome [2]
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Number of Participants With Residual Cancer Burden (RCB)
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Assessment method [2]
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RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
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Timepoint [2]
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Up to approximately 37 months
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Secondary outcome [3]
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Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
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Assessment method [3]
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RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
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Timepoint [3]
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Up to approximately 37 months
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Secondary outcome [4]
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Number of Participants With Adverse Events (AEs)
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Assessment method [4]
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Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Timepoint [4]
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From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
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Secondary outcome [5]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [5]
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Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Timepoint [5]
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From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
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Secondary outcome [6]
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Number of Participants Who Died
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Assessment method [6]
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Number of participants who died due to any cause.
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Timepoint [6]
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Up to approximately 37 months
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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
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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
- 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
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
Completed
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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
20/11/2019
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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
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Actual
27/12/2023
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Sample size
Target
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Accrual to date
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Final
521
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0071 - North Sydney
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Local Institution - 0069 - Port Macquarie
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Local Institution - 0072 - Herston
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Local Institution - 0067 - Elizabeth Vale
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Local Institution - 0066 - Clayton
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Local Institution - 0142 - Clayton
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Local Institution - 0070 - Melbourne
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Local Institution - 0068 - North Ballarat
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Recruitment postcode(s) [1]
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2060 - North Sydney
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2444 - Port Macquarie
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4029 - Herston
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5112 - Elizabeth Vale
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3168 - Clayton
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3000 - Melbourne
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Recruitment postcode(s) [7]
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33500 - North Ballarat
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Recruitment outside Australia
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Hamburg
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Country [104]
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0
Germany
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Heidelberg
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Germany
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Homburg
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Country [106]
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Germany
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Köln
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Country [107]
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Germany
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Leipzig
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Country [108]
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Germany
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Moenchengladbach
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Country [109]
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Germany
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Rostock
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Country [110]
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Germany
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Velbert
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Country [111]
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Germany
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State/province [111]
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Würzburg
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Country [112]
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Hong Kong
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Hong Kong
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Country [113]
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Ireland
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Dublin
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Country [114]
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Ireland
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Beaumont
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Country [115]
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Ireland
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State/province [115]
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Cork
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Country [116]
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Italy
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Catanzaro
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Country [117]
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Italy
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Milano
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Country [118]
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Italy
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Napoli
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Italy
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Padova
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Country [120]
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Italy
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Pavia
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Country [121]
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Italy
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Roma
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Country [122]
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Italy
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Rozzano (MI)
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Mexico
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BAJA California
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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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Mexico
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Yucatán
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Mexico
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Campeche
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Mexico
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Chihuahua
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Mexico
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Colima
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Mexico
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Oaxaca
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Deventer
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Netherlands
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Utrecht
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Country [138]
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Poland
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Bydgoszcz
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Poland
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Koszalin
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Opole
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Country [143]
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Poland
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State/province [143]
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Warszawa
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Poland
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Slaskie
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Portugal
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Lisboa
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Country [146]
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Portugal
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Porto
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Country [147]
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Puerto Rico
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Ponce
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Country [148]
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Romania
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Bucharest
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Country [149]
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Romania
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Bucuresti
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Country [150]
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Romania
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State/province [150]
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Craiova
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Country [151]
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Romania
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State/province [151]
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Floresti
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Country [152]
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Romania
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State/province [152]
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Suceava
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Country [153]
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Russian Federation
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Krasnodar
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Country [154]
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Russian Federation
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Moscow
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Country [155]
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Russian Federation
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Moskva
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Country [156]
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Russian Federation
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Ryazan
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Country [157]
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Russian Federation
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Saint Petersburg
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Country [158]
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Russian Federation
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Sankt-Peterburg
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Country [159]
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Russian Federation
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Sochi
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Country [160]
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Singapore
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Singapore
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Country [161]
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Spain
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Alicante
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Country [162]
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Spain
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Barcelona
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Country [163]
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Spain
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State/province [163]
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Madrid
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Country [164]
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Spain
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Malaga
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Country [165]
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Spain
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Pamplona
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Country [166]
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Spain
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State/province [166]
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Santiago de Compostela
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Country [167]
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Spain
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Sevilla
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Country [168]
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Spain
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Valencia
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Country [169]
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Switzerland
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Basel
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Country [170]
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Switzerland
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Lausanne
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Country [171]
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Switzerland
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Thun
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Country [172]
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Taiwan
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Kaohsiung
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Taiwan
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Tainan City
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Taiwan
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State/province [174]
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Tainan
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Country [175]
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Taiwan
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Taipei
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Country [176]
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Turkey
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State/province [176]
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Adana
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Country [177]
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Turkey
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State/province [177]
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Ankara
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Country [178]
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Turkey
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Antalya
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Country [179]
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Turkey
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Istanbul
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Country [180]
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United Kingdom
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Manchester
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Country [181]
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04109066
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Public notes
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Contacts
Principal investigator
Name
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0
Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04109066
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