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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 37 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of breast cancer that tests positive for estrogen receptor, and may or may not have progesterone receptor.You have more than one tumor in different parts of your breast.You have received treatment with certain types of drugs that affect the immune system's ability to fight cancer.Cancer has spread in both breasts.Your local lab test shows that you do not have the HER2- breast cancer gene.Your tumor is a certain grade and has a specific level of a protein called ER.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.You have had cancer in one breast or both breasts before.You should be in good physical shape, with little or no impact on your daily activities due to your health.There is clear evidence that the cancer has spread to other parts of the body.Your heart is not pumping well or you have severe heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET
- Group 2: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.