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Chemotherapy

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

Utrecht, Netherlands
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 37 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether nivolumab, a drug that helps the immune system fight cancer, is more effective when combined with chemotherapy and hormone therapy in patients with a specific type of high-risk early-stage breast cancer. Nivolumab has shown promising results in various cancers, including advanced melanoma, renal cell carcinoma, and non-small cell lung cancer, with durable responses and favorable safety profiles.

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.
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.
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.

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~5280
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
~2490

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers. Chemotherapy uses drugs to kill rapidly dividing cancer cells. Targeted therapy focuses on specific molecules involved in cancer growth, such as HER2. Immunotherapy, including PD-1 inhibitors like Nivolumab, enhances the immune system's ability to recognize and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These treatments are crucial as they offer multiple strategies to combat cancer, potentially improving survival rates and quality of life for breast cancer patients.

Find a Location

Closest Location:University Cancer Blood Ctr· Athens, GA

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,067 Total Patients Enrolled
50 Trials studying Breast Cancer
7,726 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
~86 spots leftby Dec 2025