What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving PD-1 inhibitors like Nivolumab, often include chemotherapy and endocrine therapy. The side effects of these treatments can vary but typically include fatigue, nausea, vomiting, and weakness. Immune checkpoint inhibitors, such as Nivolumab, can cause immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy can lead to hair loss, anemia, increased risk of infection, and neuropathy. Endocrine therapy may cause hot flashes, mood swings, and an increased risk of osteoporosis.

What prior FDA approvals exist?

The FDA has approved several immunotherapy agents for the treatment of breast cancer, particularly focusing on PD-1 and PD-L1 inhibitors. Pembrolizumab, a PD-1 inhibitor, has been approved for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. Additionally, Atezolizumab, a PD-L1 inhibitor, has been approved for use in combination with nab-paclitaxel for the treatment of patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1. These approvals highlight the growing role of immunotherapy in the management of breast cancer.

What other types of research exist?

Promising alternatives to Nivolumab for breast cancer patients include Pembrolizumab (another PD-1 inhibitor) and Atezolizumab (a PD-L1 inhibitor). Additionally, combination therapies involving checkpoint inhibitors with chemotherapy or targeted therapies are being explored and have shown potential in clinical trials.

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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

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

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

~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

~2490

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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.