Study on Paclitaxel, Trastuzumab, and Pertuzumab Before Surgery for Inflammatory Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01796197

Provider View

This clinical trial is testing a combination of drugs, including paclitaxel, trastuzumab, and pertuzumab, to see if they can effectively treat inflammatory breast cancer before surgery. The study aims to determine if this combination can reduce the cancer and prevent it from returning.

Patient Parameters

Program Overview

This study is exploring whether a combination of drugs—paclitaxel, trastuzumab, and pertuzumab—can effectively treat inflammatory breast cancer before surgery. Trastuzumab and pertuzumab are given for a total of 12 months to see if they can help shrink the cancer and reduce the chance of it coming back. Pertuzumab is being studied in combination with the other drugs to see if it can improve treatment outcomes. The study also aims to identify which tumors respond best to this treatment by testing tumor samples before, during, and after treatment.

Description

If you decide to participate in this study, you will first undergo some tests to confirm your eligibility. These tests include a medical history review, physical exam, scans, blood tests, and heart function tests. If eligible, you will start the study treatment.

Before starting treatment, a sample of your tumor will be taken, and photos of your tumor will be captured to assess how it responds to the treatment.

On the first day of treatment, you will receive trastuzumab and pertuzumab through an IV infusion, followed by observation. If you tolerate these well, you will continue with the treatment, including paclitaxel, which is given weekly for 16 doses. Pertuzumab is given every 3 weeks, and trastuzumab is given weekly until paclitaxel is completed.

After completing the paclitaxel treatment, you will have surgery to remove the breast cancer. About 4-5 weeks after surgery, you will have two options for further treatment: either continue with trastuzumab and pertuzumab or add additional chemotherapy with doxorubicin and cyclophosphamide.

Radiation therapy will follow, and then maintenance therapy with trastuzumab and pertuzumab will continue every 3 weeks to complete a 12-month treatment period.

You will have regular follow-up visits to monitor your health and check for any long-term side effects or cancer recurrence. These visits will include physical exams, blood tests, and mammograms, and will continue for up to 13 years after the study starts.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of invasive breast cancer
  • HER2 positive breast cancer
  • Diagnosed with inflammatory breast cancer
  • No evidence of cancer spread to organs or bones, but extensive lymph node involvement is allowed
  • Willing to have a research biopsy of the affected breast

Exclusion Criteria

  • Previous treatment for breast cancer
  • Currently receiving other investigational or commercial treatments
  • Known brain metastases
  • Lung disease or extensive lung tumor causing breathing difficulties
  • Allergic reactions to similar drugs
  • Uncontrolled illness
  • Pregnant or breastfeeding
  • History of another cancer unless disease-free for 5 years or low risk of recurrence
  • HIV positive and on anti-retroviral therapy

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