Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

NCT00295893 | Active Not Recruiting Phase 2 Results DMC

• 3 other identifiers: 05015P30CA033572CDR0000455631
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer; Paget disease of the breast with invasive ductal carcinoma; invasive ductal breast carcinoma with predominant intraductal component; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; comedo ductal breast carcinoma; invasive lobular breast carcinoma with predominant in situ component; invasive lobular breast carcinoma; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma

Outcome Measures

Primary Outcomes (2)

• Count of Patients With Pathologic Complete Response (pCR)

  pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.

  At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months

• Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.

  RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer

  At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.

Study Arms (3)

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide

ACTIVE COMPARATOR

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin

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.

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: Carboplatin; Drug: Paclitaxel

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

EXPERIMENTAL

Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Biological: Trastuzumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

cyclophosphamide DRUG

Given IV

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

docetaxel DRUG

Given IV

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide

doxorubicin hydrochloride DRUG

Given IV

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

Trastuzumab BIOLOGICAL

Given IV

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

Carboplatin DRUG

Given IV

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

Paclitaxel DRUG

Given IV

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin; Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms; Breast Neoplasms, Male; Carcinoma, Ductal, Breast; Carcinoma, Lobular

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin; Trastuzumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Joanne Mortimer, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: September 27, 2005
• Primary Completion: December 30, 2013
• Study Completion (Estimated): August 11, 2026
• Last Updated: September 25, 2025
• Results First Posted: March 14, 2023

Record last verified: 2025-09

Locations

US (1)