Study on the Effectiveness and Safety of Pre-Surgery Chemotherapy for Locally Advanced Triple Negative Breast Cancer

Sponsor: Fudan University

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01216124

Provider View

This clinical trial is exploring a new chemotherapy approach for patients with locally advanced triple negative breast cancer (TNBC) to see if it can effectively treat the cancer before surgery. The study focuses on using a combination of two drugs, oxaliplatin and docetaxel, to improve treatment outcomes.

Patient Parameters

Program Overview

Triple negative breast cancer (TNBC) is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth. This study is testing a new combination of chemotherapy drugs, oxaliplatin and docetaxel, to see if they can work together to shrink tumors in patients with locally advanced TNBC before surgery. Oxaliplatin is a drug that has shown promise in treating other types of cancer, and researchers believe it could be effective for TNBC as well. The study aims to determine how well this combination works and how safe it is for patients.

Description

This study is for women aged 18 and older who have been diagnosed with locally advanced triple negative breast cancer (TNBC) that has not yet been treated with any systemic therapy. Participants will receive a combination of two chemotherapy drugs, oxaliplatin and docetaxel, before undergoing surgery to remove the cancer. The treatment is given every 21 days for up to four cycles, unless the cancer progresses or side effects become too severe.

Before starting treatment, participants will take a medication called dexamethasone to help reduce side effects. During the treatment, participants will also receive vitamins C and B2 to support their health. The study will monitor the size of the tumor using MRI scans every two cycles to see how well the treatment is working.

Participants will have regular blood tests and health checks to ensure they are responding well to the treatment and to monitor for any side effects. The study will also collect information on the tumor's characteristics and the patient's health to better understand the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 to 65 years old.
  • Diagnosed with invasive breast cancer that is only in one breast.
  • Cancer that can be completely removed by surgery.
  • No remaining cancer after surgery.
  • Cancer must be triple negative, meaning it does not have estrogen, progesterone, or HER2 receptors.
  • No signs of cancer spreading to other parts of the body.
  • No severe nerve damage.
  • Good overall health with a performance status of 0 or 1.
  • Healthy blood cell counts and organ function.
  • Willing to use birth control during the study if of childbearing potential.
  • Normal heart function.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Cancer in both breasts or a specific type of cancer in the opposite breast.
  • Cancer that has spread to other parts of the body.
  • Certain types of breast cancer that are not triple negative.
  • Previous cancer within the last 5 years, except for certain skin cancers.
  • Participation in another clinical trial with an experimental drug.
  • Severe or uncontrolled medical conditions or infections.
  • Heart function below normal levels.
  • Significant heart disease within the last 6 months.
  • Severe allergic reactions to study drugs.
  • Women who are pregnant or breastfeeding, or who cannot use birth control during the study.
  • Psychological or social conditions that could affect participation in the study.
  • Individuals under legal guardianship or with restricted freedom.

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