NCT04109066|CompletedPhase 3ResultsDMCFDA Drug

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

CheckMate 7FL

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

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

CA209-7FL

Study Type

interventional

Target

521

Locations

31 countries

Sites

232

Timeline

RegisteredSep 2019

StartedNov 2019

CompletionDec 2023

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

521

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline

Completed

Started Nov 2019

Geographic Reach

31 countries

232 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

September 27, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed

3 months until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed

Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

3.2 years

First QC Date

September 27, 2019

Results QC Date

January 12, 2024

Last Update Submit

December 16, 2024

Conditions

Breast Cancer

Keywords

NivolumabBreast CancerCancerEstrogen Receptor-Positive (ER+)Human Epidermal Growth Factor 2 Negative (HER2-)NeoadjuvantAdjuvantPrimary Breast Cancer

Outcome Measures

Primary Outcomes (1)

Pathological Complete Response (pCR) Rate
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.
Up to approximately 37 months

Secondary Outcomes (6)

Pathological Complete Response (pCR) Rate (PD-L1 >=1%)
Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB)
Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
Up to approximately 37 months
Number of Participants With Adverse Events (AEs)
From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)
Number of Participants With Serious Adverse Events (SAEs)
From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)
+1 more secondary outcomes

Study Arms (2)

Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

EXPERIMENTAL

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

Biological: nivolumabDrug: paclitaxel (PTX)Drug: anthracyclineDrug: cyclophosphamideDrug: Endocrine TherapyProcedure: Surgery

Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET

PLACEBO COMPARATOR

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

Drug: paclitaxel (PTX)Other: nivolumab placeboDrug: anthracyclineDrug: cyclophosphamideDrug: Endocrine TherapyProcedure: Surgery

Interventions

nivolumabBIOLOGICAL

Specified Dose on Specified days

Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

paclitaxel (PTX)DRUG

Specified dose on Specified days