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
Sponsor: Bristol-Myers Squibb
Listed as NCT04109066, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Bristol-Myers Squibb, it has been updated 47 times since 2019, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
47 versions recorded-
Dec 2025 — Present [monthly]
Completed PHASE3
-
Nov 2025 — Dec 2025 [monthly]
Completed PHASE3
-
Sep 2025 — Nov 2025 [monthly]
Completed PHASE3
-
Feb 2025 — Sep 2025 [monthly]
Completed PHASE3
-
Sep 2024 — Feb 2025 [monthly]
Completed PHASE3
▶ Show 42 earlier versions
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Apr 2024 — Jul 2024 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
-
Jan 2024 — Apr 2024 [monthly]
Active Not Recruiting PHASE3
-
Dec 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE3
-
Nov 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE3
-
Oct 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE3
-
Sep 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE3
-
Aug 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE3
-
Jul 2023 — Aug 2023 [monthly]
Active Not Recruiting PHASE3
-
Jun 2023 — Jul 2023 [monthly]
Active Not Recruiting PHASE3
-
May 2023 — Jun 2023 [monthly]
Active Not Recruiting PHASE3
-
Apr 2023 — May 2023 [monthly]
Active Not Recruiting PHASE3
-
Mar 2023 — Apr 2023 [monthly]
Active Not Recruiting PHASE3
-
Feb 2023 — Mar 2023 [monthly]
Active Not Recruiting PHASE3
-
Jan 2023 — Feb 2023 [monthly]
Active Not Recruiting PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE3
-
Nov 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE3
-
Sep 2022 — Nov 2022 [monthly]
Active Not Recruiting PHASE3
-
Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE3
-
Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
-
Apr 2022 — Jun 2022 [monthly]
Recruiting PHASE3
-
Mar 2022 — Apr 2022 [monthly]
Recruiting PHASE3
-
Feb 2022 — Mar 2022 [monthly]
Recruiting PHASE3
-
Jan 2022 — Feb 2022 [monthly]
Recruiting PHASE3
-
Dec 2021 — Jan 2022 [monthly]
Recruiting PHASE3
-
Nov 2021 — Dec 2021 [monthly]
Recruiting PHASE3
-
Sep 2021 — Nov 2021 [monthly]
Recruiting PHASE3
-
Feb 2021 — Sep 2021 [monthly]
Recruiting PHASE3
-
Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE3
-
Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE3
-
Nov 2020 — Dec 2020 [monthly]
Recruiting PHASE3
-
Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE3
-
Sep 2020 — Oct 2020 [monthly]
Recruiting PHASE3
-
Aug 2020 — Sep 2020 [monthly]
Recruiting PHASE3
-
Jul 2020 — Aug 2020 [monthly]
Recruiting PHASE3
-
Apr 2020 — Jul 2020 [monthly]
Recruiting PHASE3
-
Mar 2020 — Apr 2020 [monthly]
Recruiting PHASE3
-
Feb 2020 — Mar 2020 [monthly]
Recruiting PHASE3
-
Jan 2020 — Feb 2020 [monthly]
Recruiting PHASE3
-
Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Nov 2019 — Dec 2019 [monthly]
Not Yet Recruiting PHASE3
-
Oct 2019 — Nov 2019 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bristol-Myers Squibb
For direct contact, visit the study record on ClinicalTrials.gov .