Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab, carboplatin, cyclophosphamide, docetaxel, doxorubicin hydrochloride, paclitaxel
Phase phase 2
Target HER2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date September 2005
End date January 2017
Trial size 105 participants
Trial identifier NCT00295893, 05015, CDR0000455631, P30CA033572

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
carboplatin
Given IV
cyclophosphamide
Given IV
docetaxel
Given IV
doxorubicin hydrochloride
Given IV
paclitaxel
Given IV
(Experimental)
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
carboplatin
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
paclitaxel
Given IV
(Experimental)
Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
trastuzumab
Given IV
carboplatin
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
paclitaxel
Given IV

Primary Outcomes

Measure
Complete response rate
time frame: At the time of surgery within 4 weeks of the end of chemotherapy
Feasibility
time frame: At the time of surgery within 4 weeks of the end of chemotherapy

Secondary Outcomes

Measure
Quality of life and neuropathy assessment of prognostic and predictive markers as measured by FACT exploratory methods at 1 year
time frame: 1 year post treatment

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer
Principal investigator George Somlo, MD
Description OBJECTIVES: Primary - Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer. - Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer. Secondary - Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy. OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III. - Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses. - Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses. - Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery. PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.