Clinical Trial: Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer

Brief Summary:

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the antitumor activity of trastuzumab (Herceptin^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.

Secondary

  • Determine the pathological complete response in patients treated with this regimen.
  • Determine the disease-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

  • Course 1 (days 1-28): Patients receive trastuzumab (Herceptin^®) IV over 30-90 minutes on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8.
  • Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 5 additional courses (6 courses total) in the absence of disease progression or unacceptable toxicity.

Three weeks after completion of course 6, patients undergo restaging. Patients with local operable disease undergo modified
Sponsor: University of Medicine and Dentistry of New Jersey

Current Primary Outcome: Antitumor Activity as Measured by Response Rate [ Time Frame: 5 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Pathological Complete Response [ Time Frame: 5 years ]
  • Disease-free Survival [ Time Frame: 10 years ]
  • Pathologic and Molecular Markers for Predicting Efficacy [ Time Frame: 5 years ]


Original Secondary Outcome:

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: July 8, 2005
Date Started: April 2005
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013