Study on Pertuzumab, Trastuzumab, and Paclitaxel for Treating HER2-Positive Advanced Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01730833

Provider View

This clinical trial is testing a combination of drugs, including pertuzumab, trastuzumab, and paclitaxel, to see how well they work together in treating patients with advanced HER2-positive breast cancer.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs—pertuzumab, trastuzumab, and paclitaxel—works in treating patients with advanced HER2-positive breast cancer. These drugs are designed to block the growth of cancer cells in different ways. Pertuzumab and trastuzumab are antibodies that can stop cancer cells from growing and spreading, while paclitaxel is a chemotherapy drug that kills cancer cells or stops them from growing. The study aims to find out if using these drugs together is more effective in controlling cancer growth.

Description

The main goals of this study are to see how effective the combination of pertuzumab, trastuzumab, and paclitaxel is in treating advanced HER2-positive breast cancer and to evaluate the safety of this treatment. The study will measure how long patients live without their cancer getting worse and how well the treatment works before surgery in patients with locally advanced breast cancer.

Secondary goals include assessing the safety of the treatment by monitoring side effects and changes in health, measuring how well the cancer responds to the treatment, and evaluating the overall survival of patients. The study will also explore genetic and molecular changes in the cancer cells and in the blood.

Patients will receive the drugs through an IV on specific days in a 21-day cycle. The treatment will continue as long as it is effective and safe, or for up to six cycles for patients with locally advanced breast cancer. After completing the treatment, patients will have follow-up visits every few months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HER2-positive advanced breast cancer, either metastatic (spread to other parts of the body) or locally advanced.
  • Women and men must agree to use effective birth control during the study and for six months after.
  • Cancer must be HER2-positive, confirmed by specific tests.
  • No prior treatment for locally advanced breast cancer.
  • For metastatic cancer, previous chemotherapy and trastuzumab are allowed if completed at least 12 months before joining the study.
  • Good heart function and overall health.
  • Blood tests showing adequate levels of hemoglobin, white blood cells, neutrophils, and platelets.
  • Normal liver and kidney function.
  • No serious medical conditions that could be worsened by the treatment.
  • No other active cancers, except for certain skin cancers.
  • Ability to understand and sign informed consent.
  • Negative pregnancy test for women of childbearing potential.
  • No prior treatment with nab-paclitaxel for breast cancer.

Exclusion Criteria

  • Active hepatitis B or C infection.
  • Active HIV infection.
  • Previous breast cancer or other invasive cancer treated within the last 5 years.
  • Pregnant or breastfeeding women.
  • Severe nerve damage.
  • Any medical or psychological condition that could interfere with the study.
  • High cumulative dose of certain chemotherapy drugs in the past.
  • Heart function below required levels during previous trastuzumab treatment.
  • Cancer spread to the brain.
  • Other active cancers, except for certain skin cancers.
  • Inability to comply with study requirements.

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