Phase II Study on Personalized Chemoimmunotherapy for Early-Stage Triple Negative Breast Cancer with High Immune Cell Levels

Sponsor: Medical University of South Carolina

Sponsor score: 0

ClinicalTrials ID:NCT07743190

This study is exploring a new treatment approach for early-stage triple negative breast cancer patients whose tumors have high levels of immune cells. The aim is to see if a combination of chemotherapy and immunotherapy can effectively treat the cancer without using certain drugs that have more side effects.

Patient Parameters

Parameter	Options

Program Overview

This clinical trial is testing a new treatment for people with early-stage triple negative breast cancer who have a high number of immune cells in their tumors. These immune cells, called tumor-infiltrating lymphocytes (TILs), suggest that the cancer might respond well to a combination of chemotherapy and immunotherapy. The study aims to see if this approach can work without using anthracyclines, a type of chemotherapy that can cause heart and bone marrow issues. Patients will receive 12 weeks of chemotherapy (carboplatin and paclitaxel) and the immunotherapy drug pembrolizumab before surgery. If no cancer is found during surgery, patients will continue with pembrolizumab alone. If cancer remains, they will receive additional chemotherapy with anthracyclines and pembrolizumab. The goal is to tailor treatment to each patient, using stronger therapy only when necessary. The main success measure is the rate of complete cancer disappearance, with other measures including cancer-free survival and overall survival.

Description

The NeoTILs trial is a Phase II study focusing on patients with early-stage triple negative breast cancer who have high levels of tumor-infiltrating lymphocytes (TILs). These patients will receive a 12-week treatment of carboplatin, paclitaxel, and pembrolizumab before surgery, without using anthracyclines. The study aims to see if this treatment can achieve similar success rates to previous treatments that included anthracyclines. After surgery, if no cancer is found, patients will continue with pembrolizumab alone. If cancer is still present, they will receive additional chemotherapy with anthracyclines and pembrolizumab. The study will monitor the complete disappearance of cancer, survival rates, and side effects. Patients will be followed for at least five years to track their progress and overall health.

Eligibility Criteria

Inclusion Criteria

Be 18 years or older.
Understand and agree to sign a consent form.
Have a confirmed diagnosis of triple negative breast cancer at Stage II or IIIA/B.
Have tumors that are estrogen and progesterone receptor negative or low, and HER2-negative.
Have a performance status score of 0 to 2, indicating good overall health.
Use effective contraception if of childbearing potential.
Agree to follow all study procedures and attend scheduled visits.
Have recent imaging tests of the breast and axillary area.
Have measurable disease in the breast or biopsy-proven lymph node involvement.
Have adequate blood counts and organ function.
Have good heart function.
If HIV-positive, be on effective treatment with an undetectable viral load.
If hepatitis B or C positive, have the infection under control or cured.

Exclusion Criteria

Have less than 30% tumor-infiltrating lymphocytes.
Have Stage N3, inflammatory, or metastatic breast cancer.
Have had another cancer within the past 3 years, except for certain skin or cervical cancers.
Have received prior treatment for the current breast cancer.
Have used immune checkpoint inhibitors or investigational treatments recently.
Have severe allergies to study drugs.
Have uncontrolled diabetes or high blood pressure.
Have a history of organ transplant or active autoimmune disease.
Have had recent major surgery or severe infection.
Be pregnant or breastfeeding.
Have a history of severe lung issues or active infections.
Have psychiatric or substance abuse issues that interfere with the study.
Have received live vaccines recently.

Locations

FACILITY	ZIP	CITY	STATE
SUNY Upstate Medical University	13210	Syracuse	New York
Medical University of South Carolina Hollings Cancer Center,	29425	Charleston	South Carolina

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