Phase II Study of Carboplatin with or without Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

Sponsor: Kathy Miller

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05846789

Provider View

This clinical trial is exploring whether adding the drug tocilizumab to the chemotherapy drug carboplatin can improve treatment outcomes for patients with metastatic triple negative or ER-low breast cancer. The study includes both Black and non-Black patients.

Patient Parameters

Program Overview

This study is testing two treatment options for patients with metastatic triple negative or ER-low breast cancer: carboplatin alone or carboplatin combined with tocilizumab. The trial aims to see if the combination treatment is more effective. Patients will be randomly assigned to one of the two treatment groups. The study will initially include 42 patients in each group, and if the results are promising, more patients will be added.

Description

This clinical trial is designed to compare the effectiveness of carboplatin alone versus carboplatin combined with tocilizumab in treating metastatic triple negative or ER-low breast cancer. The study will include both Black and non-Black patients. Participants will be randomly assigned to receive either carboplatin by itself or in combination with tocilizumab. The trial will start with 42 patients in each treatment group, and if the combination shows better results, more patients will be enrolled. The study will help determine if adding tocilizumab can improve treatment outcomes for this type of breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to provide written consent to participate.
  • Have breast cancer that is either triple negative or has low estrogen receptor (ER) levels, and is either locally advanced or has spread to other parts of the body.
  • Have not received chemotherapy for metastatic disease.
  • Have measurable cancer based on specific criteria.
  • Cancer must be suitable for a study-specific biopsy.
  • Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
  • If there is a history of brain metastases, they must be treated and stable, with no need for ongoing steroid treatment.
  • Have adequate organ function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after treatment.

Exclusion Criteria

  • Have been treated with or cannot take tocilizumab or similar drugs.
  • Have a type of cancer that is positive for PD-L1 unless unable to take pembrolizumab.
  • Have an active infection needing IV antibiotics.
  • Are taking methotrexate or systemic steroids.
  • Have active or symptomatic brain disease.
  • Have HER2-positive breast cancer.
  • Have another active cancer besides breast cancer.
  • Have had radiation therapy within two weeks before joining the study.
  • Have had hormone therapy within two weeks before joining the study.

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