Study on Combination Chemotherapy With or Without Trastuzumab for Stage II or III Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT00295893

Provider View

This clinical trial is exploring whether adding the drug trastuzumab to combination chemotherapy before surgery can improve treatment outcomes for patients with stage II or III breast cancer.

Patient Parameters

Program Overview

The study aims to find out if using a combination of chemotherapy drugs, with or without the addition of trastuzumab, can help shrink tumors in patients with stage II or III breast cancer before surgery. Chemotherapy drugs work by killing cancer cells or stopping them from growing. Trastuzumab is a type of drug that can block cancer cell growth and help the immune system target and destroy cancer cells. Researchers want to see if adding trastuzumab to chemotherapy makes the treatment more effective.

Description

This study is divided into different treatment groups based on the type of breast cancer.

  • Primary Goals:

    • Compare two chemotherapy treatments to see which is more effective and has fewer side effects for patients with stage II or III breast cancer that does not overexpress HER2/neu.
    • Determine if adding trastuzumab to one of the chemotherapy treatments improves outcomes for patients with HER2/neu overexpressing breast cancer.

  • Secondary Goals:

    • Identify markers that can predict how well patients will respond to treatment and the likelihood of cancer returning.

  • Treatment Groups:

    • Group I: Patients receive a combination of three chemotherapy drugs: doxorubicin, cyclophosphamide, and docetaxel. This treatment is given every 21 days for a total of 6 cycles.
    • Group II: Patients receive two chemotherapy drugs, doxorubicin and cyclophosphamide, every 2 weeks for 4 cycles. After that, they receive carboplatin and paclitaxel every 4 weeks for 3 cycles.
    • Group III: Patients receive the same treatment as Group II, but with the addition of trastuzumab, which is given weekly starting with the first doses of carboplatin and paclitaxel.

After completing chemotherapy, with or without trastuzumab, all patients will have surgery within 4 weeks.

The study plans to enroll a total of 105 patients.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven infiltrating ductal or lobular breast carcinoma

    • Stage II or III disease
    • Inflammatory breast cancer allowed

  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • ECOG performance status < 2

  • Male or female

  • Menopausal status not specified (for female patients)

  • Absolute neutrophil count ≥ 1,500/mm^3

  • Platelet count ≥ 100,000/mm^3

  • Bilirubin normal (except for patient's with Gilbert's disease)

  • Creatinine ≤ 1.2 mg/dL

  • Creatinine clearance ≥ 70 mL/min

  • Ejection fraction ≥ 50% on MUGA

  • No neuropathy ≥ grade 1

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective nonhormonal contraception

  • No prior malignant disease within the past 5 years, excluding:

    • Squamous cell or basal cell skin carcinoma
    • Stage I or in situ cervical carcinoma

  • No noninvasive (in situ) breast carcinoma within the past 5 years

PRIOR CONCURRENT THERAPY:

  • At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
  • No prior radiotherapy to the chest wall

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010-3000DuarteCalifornia

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