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Chemotherapy

Nivolumab + Chemotherapy + Endocrine Therapy for Breast Cancer (CheckMate 7FL Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 37 months
Awards & highlights

CheckMate 7FL Trial Summary

This trial is testing if adding the immunotherapy drug nivolumab to neoadjuvant and adjuvant chemotherapy and endocrine therapy can help treat high-risk ER+, HER2- early stage breast cancer.

Who is the study for?
This trial is for adults with high-risk, ER+, HER2- early stage breast cancer eligible for surgery. They must have a specific type of tumor and agree to provide tissue samples. Exclusions include prior treatments, multiple tumors in different breast quadrants, pregnancy, or significant heart disease.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Nivolumab (an immunotherapy drug) versus placebo when combined with pre-surgery chemotherapy and post-surgery endocrine therapy in treating certain types of early-stage breast cancer.See study design
What are the potential side effects?
Nivolumab can cause immune-related side effects such as inflammation in organs like lungs or intestines, skin rash, hormone gland problems (like thyroid), fatigue, infusion reactions, and potential complications from combining it with chemotherapy.

CheckMate 7FL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have invasive breast ductal carcinoma that is a certain size and has spread to nearby lymph nodes. The lymph node status must be confirmed by a specific type of biopsy.
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You should be in good physical shape, with little or no impact on your daily activities due to your health.

CheckMate 7FL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 37 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological Complete Response (pCR) Rate
Secondary outcome measures
Number of Participants Who Died
Number of Participants With Adverse Events (AEs)
Number of Participants With Residual Cancer Burden (RCB)
+3 more

CheckMate 7FL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ETExperimental Treatment6 Interventions
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
Group II: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ETPlacebo Group6 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
cyclophosphamide
1994
Completed Phase 3
~8140
nivolumab
2016
Completed Phase 3
~4960
paclitaxel (PTX)
2019
Completed Phase 3
~530
Endocrine Therapy
2013
Completed Phase 3
~680
anthracycline
2019
Completed Phase 3
~530
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,015 Total Patients Enrolled
50 Trials studying Breast Cancer
7,744 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04109066 — Phase 3
Breast Cancer Research Study Groups: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET, Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04109066 — Phase 3
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109066 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there long-term repercussions to nivolumab treatments?

"There is a significant volume of data supporting the safety of nivolumab, so it received a score of 3."

Answered by AI

How does nivolumab compare to other treatments in clinical trials?

"Nivolumab is being trialled in 2334 concurrent studies, with 433 of those in Phase 3. Most of these investigations are based in Ciudad de Mexico and Maryland, though there are 98491 clinical trial centres spread out across the globe."

Answered by AI

What are some of the conditions that nivolumab has been shown to be most effective in treating?

"Nivolumab is a cancer medication that can be used to treat metastatic urothelial carcinoma, as well as other diseases such as metastatic hepatocellular carcinoma, malignant melanoma of skin, and leukemia."

Answered by AI

Can additional people still enroll in this research project?

"No, this study is not currently looking for volunteers. However, according to the data on clinicaltrials.gov, this study was last edited on 10/31/2022. Additionally, while this specific study might not be recruiting right now, there are 5017 other clinical trials that are."

Answered by AI

How many patients will be allowed to enroll in this clinical trial?

"This study is not currently looking for patients. The trial was originally posted on 20 November 2019 but was last edited on 31 October 2020. There are 2683 trials actively searching for patients with breast cancer and 2334 trials for nivolumab that are still recruiting patients."

Answered by AI
~98 spots leftby Mar 2025