Study on Carboplatin and Paclitaxel With or Without Panitumumab for Treating Invasive Triple Negative Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02876107

Provider View

This clinical trial is exploring whether adding the drug panitumumab to the chemotherapy drugs carboplatin and paclitaxel can improve treatment outcomes for patients with invasive triple negative breast cancer. The study aims to see if this combination can shrink tumors before surgery, potentially reducing the amount of tissue that needs to be removed.

Patient Parameters

Program Overview

This study is testing how well the chemotherapy drugs carboplatin and paclitaxel work with or without the addition of panitumumab in treating patients with invasive triple negative breast cancer. These drugs work by stopping cancer cells from growing and spreading. Panitumumab is a type of monoclonal antibody that may help prevent tumor cells from growing. The goal is to see if this combination can make tumors smaller before surgery, which might help preserve more normal tissue.

Description

The study has two main groups:

  • Group A: Patients receive panitumumab along with carboplatin and paclitaxel. Panitumumab is given through an IV on specific days, and carboplatin and paclitaxel are also given through an IV on a set schedule. This treatment cycle repeats every 21 days for up to 8 cycles, as long as the cancer does not progress or cause unexpected side effects.

  • Group B: Patients receive carboplatin and paclitaxel, along with additional drugs doxorubicin and cyclophosphamide, similar to Group A. The treatment cycle is the same, repeating every 21 days for up to 8 cycles.

After completing the treatment, patients will have follow-up visits at 1 month and then annually for at least 5 years to monitor their health and the effectiveness of the treatment.

The study's primary goal is to determine the rate of complete response to the treatment, meaning no signs of cancer remain. Secondary goals include assessing disease-free survival, overall survival, and the safety of the treatments. Researchers will also explore various biological markers to understand how they relate to treatment response.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of invasive breast cancer.
  • Cancer must be triple negative, meaning it does not express estrogen, progesterone, or HER2 receptors.
  • Must have a specific type of breast cancer characterized by rapid onset and significant redness and swelling.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate heart function and specific blood cell counts and organ function levels.
  • Must be able to provide informed consent and agree to use effective birth control if of childbearing potential.

Exclusion Criteria

  • Cannot have stage IV breast cancer that cannot be treated with local therapies like surgery or radiation.
  • Cannot have had previous radiation therapy for the current breast cancer diagnosis.
  • Cannot have had another cancer within the last 5 years, except for certain skin or cervical cancers.
  • Cannot have certain infections like HIV or hepatitis.
  • Cannot have significant lung disease or other serious medical conditions that could interfere with the study.
  • Cannot have uncontrolled illnesses or severe heart conditions.
  • Cannot have a history of certain chemotherapy treatments or have received high doses of specific drugs in the past.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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