What is the mechanism of action of this treatment?

Immunotherapy for breast cancer works by stimulating the immune system to recognize and attack cancer cells. This is often achieved through checkpoint inhibitors that block proteins preventing immune cells from attacking the cancer. This treatment is significant for breast cancer patients as it offers a targeted approach, potentially leading to fewer side effects and providing durable responses and long-term remission for some patients.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly immunotherapy, can lead to a range of side effects. Immunotherapy, which stimulates the immune system to attack cancer cells, often results in cutaneous immune-related adverse events such as rash, pruritus (itching), and vitiligo. Other side effects may include fatigue, nausea, fever, and chills. Additionally, patients may experience more severe immune-related toxicities affecting various organs, necessitating the use of steroids or other immunosuppressive agents to manage these reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapy treatments for breast cancer, particularly for triple-negative breast cancer (TNBC). Pembrolizumab, an anti-PD-1 monoclonal antibody, is approved for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1. Additionally, atezolizumab, an anti-PD-L1 antibody, was previously approved for use with nab-paclitaxel in PD-L1-positive metastatic TNBC, although this indication was later withdrawn. These treatments work by stimulating the immune system to recognize and attack cancer cells.

What other types of research exist?

Promising novel alternatives to immunotherapy for breast cancer patients in 2024 include targeted therapies and novel drug combinations. These include PARP inhibitors for patients with BRCA mutations, CDK4/6 inhibitors for hormone receptor-positive breast cancer, and antibody-drug conjugates like trastuzumab deruxtecan for HER2-positive breast cancer. Additionally, advancements in personalized medicine, such as the use of genomic profiling to tailor treatments, and the development of new hormonal therapies, are also promising.

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Chemotherapy

Chemoimmunotherapy for Triple-Negative Breast Cancer (NeoTRACT Trial)

Phase 2

Recruiting

Led By Shane R Stecklein, MD, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines

Histologically confirmed cT1c-T3 cN0-N2 cM0 TNBC

Must not have

Myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP > 160 mmHg, diastolic BP > 90 mmHg), uncontrolled or symptomatic arrythmia, or greater than grade 2 peripheral vascular disease

Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy (in doses exceeding 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within seven days prior to the first dose of pembrolizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if having certain cells around the tumor helps shrink it in patients with a specific type of breast cancer who are receiving a combination of treatments before surgery. The goal is to see if these cells and imaging tests can help customize treatment for better results. Recent developments have shown that some aggressive types of this breast cancer are resistant to treatment and have a poor prognosis.

Who is the study for?

This trial is for women aged 18-70 with triple-negative breast cancer (TNBC) that hasn't spread beyond the breasts and lymph nodes. Participants must have tumors that are hormone receptor poor, HER2-negative, no prior treatments or surgeries for their current breast cancer, and good heart function. They should not be pregnant or breastfeeding and must agree to use contraception.

What is being tested?

The study tests if immune cells around TNBC affect how well the tumor responds to a combination of chemotherapy drugs (Doxorubicin, Carboplatin, Docetaxel, Cyclophosphamide) plus an immunotherapy drug called Pembrolizumab given before surgery.

What are the potential side effects?

Possible side effects include allergic reactions to medications used; fatigue; hair loss; nausea; increased risk of infections due to lowered white blood cell counts; heart problems from Doxorubicin; nerve damage from Docetaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My invasive tumor is not HER2 positive according to the latest guidelines.

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My breast cancer is in stages 1C to 3, has possibly spread to nearby lymph nodes but not to distant parts of the body.

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I do not have severe nerve damage.

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I am a woman aged between 18 and 70.

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I haven't received any treatment for my current breast cancer.

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My breast cancer is not driven by hormones.

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I haven't had surgery on the same breast for my current cancer.

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I have given a sample of my breast tumor for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a heart attack, stroke, or severe heart issues in the last year and my blood pressure is controlled.

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I have an immune system disorder or have been on high-dose steroids or other drugs that weaken my immune system recently.

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I have had non-infectious lung inflammation treated with steroids in the past year.

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I have inflammatory breast cancer.

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I have been diagnosed with HIV.

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I am allergic to doxorubicin, cyclophosphamide, carboplatin, or docetaxel.

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I am currently on medication for an infection.

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I have had treatment for breast cancer before.

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My blood, kidney, liver, or heart function is not good.

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My cancer has spread to other parts of my body.

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I have been treated with specific immune system-targeting drugs before.

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I have an autoimmune disease treated with strong medication in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 in high sTIL cohort with radiographic complete response

Secondary study objectives

Recurrence-free, event-free, and overall survival

Residual cancer burden (RCB) 0+1 rate in high sTIL cohort with radiographic complete response

pCR and RCB 0+1 in intermediate sTIL cohort

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: High sTILs (≥30%)Active Control3 Interventions

Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles.

Group II: Intermediate sTILs (5-29%)Active Control3 Interventions

Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for six cycles.

Group III: Low sTILs (<5%)Active Control5 Interventions

Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles followed by Doxorubicin (60 mg/m2) + Cyclophosphamide (600 mg/m2) + Pembrolizumab (200 mg) every 14 or 21 days for four cycles.

0 / 20Eligibility criteria met

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

Immunotherapy for breast cancer works by stimulating the immune system to recognize and attack cancer cells. This is often achieved through checkpoint inhibitors that block proteins preventing immune cells from attacking the cancer. This treatment is significant for breast cancer patients as it offers a targeted approach, potentially leading to fewer side effects and providing durable responses and long-term remission for some patients.