Phase 2 Study of Weekly Carboplatin and Paclitaxel Before Surgery in Triple Negative Breast Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0

ClinicalTrials ID:NCT04083963

Provider View

This clinical trial is testing a combination of chemotherapy drugs, carboplatin and paclitaxel, given weekly before surgery to see if it is safe and effective for patients with operable Triple Negative Breast Cancer (TNBC).

Patient Parameters

Program Overview

This study aims to evaluate the safety and effectiveness of a weekly chemotherapy treatment using carboplatin and paclitaxel, followed by doxorubicin and cyclophosphamide, in patients with Triple Negative Breast Cancer (TNBC) who are planning to have surgery. The treatment is given before surgery to help shrink the tumor and make it easier to remove.

Description

In this Phase 2 study, patients with Triple Negative Breast Cancer (TNBC) will receive a combination of chemotherapy drugs before surgery. The treatment involves weekly doses of carboplatin and paclitaxel for up to 12 weeks, followed by doxorubicin and cyclophosphamide for four cycles. The goal is to see if this approach is safe and can effectively reduce the size of the tumor before surgery. Adjustments to the treatment schedule may be made based on how well patients tolerate the drugs. The study will help determine if this combination of drugs is a good option for patients with TNBC.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with invasive breast cancer confirmed by a biopsy.
  • Cancer is at a stage where surgery is possible after chemotherapy.
  • Cancer is triple-negative, meaning it does not have certain hormone receptors.
  • Good overall health with a performance status score of 0, 1, or 2.
  • Life expectancy of at least 6 months.
  • Adequate blood cell counts and organ function based on specific tests.
  • No evidence of cancer spread to distant parts of the body.
  • Willing to provide informed consent and follow study procedures.
  • Women of childbearing potential must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 90 days after the last dose.

Exclusion Criteria

  • Active infection requiring treatment.
  • Pregnant or breastfeeding women.
  • Previous cancer treatment for the current breast cancer.
  • Previous treatment with the study drugs within the past 3 years.
  • Use of certain hormonal therapies.
  • History of seizures in the past 6 months.
  • Existing nerve damage beyond a certain level.
  • Recent use of investigational drugs or major surgery.
  • Other cancers that could interfere with the study.
  • History of certain blood disorders or heart conditions.
  • Severe medical conditions that could pose safety risks.
  • Any condition that might affect the patient's ability to follow the study protocol.

Locations

FACILITYZIPCITYSTATE
University of Illinois60612ChicagoIllinois

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