Study on Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05929768

Provider View

This clinical trial is comparing a shorter chemotherapy and immunotherapy treatment without anthracycline drugs to the usual treatment for early-stage triple negative breast cancer. The study aims to see if the shorter treatment is just as effective in controlling the cancer.

Patient Parameters

Program Overview

This study is testing whether a shorter chemotherapy and immunotherapy treatment, which does not include anthracycline drugs, is as effective as the usual treatment for early-stage triple negative breast cancer. The usual treatment includes drugs like paclitaxel, carboplatin, cyclophosphamide, docetaxel, doxorubicin, and pembrolizumab, which work by stopping cancer cells from growing and dividing. The study will compare the effectiveness and safety of the shorter treatment to see if it can provide the same benefits as the usual treatment.

Description

The main goal of this study is to find out if a shorter chemotherapy and immunotherapy treatment without anthracycline drugs is as effective in preventing breast cancer events as the usual treatment that includes these drugs.

Secondary goals include comparing how well the cancer responds to the treatment, the safety and side effects of the treatments, and the quality of life of patients during and after treatment. The study will also look at how the cancer's immune environment changes with treatment and collect patient-reported outcomes on fatigue and physical function.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive paclitaxel, carboplatin, and pembrolizumab, followed by doxorubicin, cyclophosphamide, and pembrolizumab, and then surgery. Pembrolizumab may continue after surgery.
  • Group 2: Will receive docetaxel, carboplatin, and pembrolizumab, followed by surgery. Pembrolizumab may continue after surgery.

Participants will have regular follow-ups every 6 months for the first 2 years and then annually for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed triple negative breast cancer (TNBC), which means the cancer is negative for estrogen, progesterone, and HER2 receptors.
  • Cancer must be at a specific stage, either T2-T4, N0, M0 or T1-T3, N1-2, M0.
  • Must have imaging tests like mammograms or MRIs within 49 days before joining the study.
  • Cannot have certain advanced stages of breast cancer or cancer that has spread to other parts of the body.
  • Must not have received previous treatment for the current breast cancer.
  • Must not have severe allergies to the study drugs or similar medications.
  • Must be 18 years or older and in good health with a performance status of 0-2.
  • Must have adequate blood counts and organ function based on specific medical tests.
  • Women of childbearing potential must agree to use effective contraception during the study.
  • Must not have uncontrolled diabetes or high blood pressure.
  • Must not have had major surgery or severe infections recently.
  • Must not have a history of certain autoimmune diseases or have received live vaccines recently.
  • Must not be pregnant or nursing.
  • Must be willing to provide a tissue sample and participate in specimen banking.
  • Must be able to complete questionnaires in English, Spanish, or French.
  • Must sign an informed consent form to participate in the study.

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