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Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Phase 2
18 Years
80 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Inclusion Criteria:

- Confirmed infiltrating adenocarcinoma of the breast

- Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence
of metastasis.

- No prior radiation to the involved breast

- ECOG performance status 0-2

- Age 18 years to 80 years

- Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and
hemoglobin > 9 g/dl

- All liver function tests < upper limit of normal

- Serum creatinine < 2.0 mg/dl

- Normal left ventricular ejection fraction (LVEF) as determined by MUGA scan or

- HER-2/neu status is determined by a FISH test. [FISH (+) is HER-2/neu (+)]

- If female of childbearing potential, pregnancy test is negative

- If premenopausal and not surgically sterilized, the patient agrees to use effective
birth control method for the duration of the study

- Informed consent has been obtained

Exclusion Criteria:

- Non-confirmed infiltrating adenocarcinoma breast cancer

- Evidence of metastasis

- Previous chemotherapy using the drugs proposed in this study, specifically
Herceptin®, Taxotere®, and/or Carboplatin

- Prior radiation to the involved breast

- Recent breast cancer drug therapy within last 5 years of any form

- History of allergy to polysorbate or castor oil

- Ongoing active infection

- Concurrent life-limiting disease with a life expectancy of less than one year

- Past or current history of other malignancy within the past 5 years which could
affect the diagnosis or assessment of breast cancer, except for curatively treated
non-melanoma skin cancer and/or in situ carcinoma of the cervix

- Pregnancy, nursing, fertile women who do not use birth control device

- Inability to give informed consent

- Patients with pre-existing peripheral neuropathy > grade 2

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Helena R. Chang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage II breast cancer
  • Breast Neoplasms



USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Wilshire Oncology Medical Group, Incorporated - Pomona Pomona, California  91767-3021