Secondary Logo

Institutional members access full text with Ovid®

Share this article on:

A Phase II Trial of Docetaxel and Carboplatin Administered Every 2 Weeks as Preoperative Therapy for Stage II or III Breast Cancer: NCCTG Study N0338

Roy, Vivek MD*; Pockaj, Barbara A. MD; Allred, Jacob B. MS; Apsey, Heidi RN; Northfelt, Donald W. MD; Nikcevich, Daniel MD§; Mattar, Bassam MD; Perez, Edith A. MD*

American Journal of Clinical Oncology: December 2013 - Volume 36 - Issue 6 - p 540–544
doi: 10.1097/COC.0b013e318256f619
Original Articles: Breast

Objective: We conducted a multicenter phase II trial to assess the efficacy and toxicity of docetaxel and carboplatin combination as neoadjuvant therapy for stage II or III breast cancer (BC).

Methods: Patients received 75 mg/m2 of docetaxel and AUC 6 of carboplatin on day 1 followed by pegfilgrastim on day 2, every 14 days for 4 cycles, followed by definitive breast surgery. The primary endpoint was the proportion of patients achieving pathologic complete remission (pCR), defined as disappearance of all invasive and in situ tumors in the breast and axilla after chemotherapy.

Results: A total of 57 women (median age, 53 y) were enrolled. Thirty-eight (67%) had ER+, 31 (54%) PR+, and 6 (11%) HER2+ disease; 9 had triple negative BC (TNBC). Forty-three (75%; 95% confidence interval, 62%-86%) of 57 eligible patients had clinical response (15 clinical complete response, 28 clinical partial response). Nine (16%; 90% confidence interval, 10%-28%) patients achieved pCR. Four of 9 (44%) patients with TNBC achieved pCR. Thrombocytopenia (5%) was the only grade 4 adverse event. The most common grade 3 adverse events were thrombocytopenia (19%), fatigue (12%), and anemia (9%).

Conclusions: Four cycles of 2-weekly Docetaxel and Carboplatin are feasible with acceptable toxicity and a pCR rate of 16%. This regimen can be considered for neoadjuvant therapy of BC, particularly for patients not eligible for anthracycline therapy. A high pCR rate of 44% noted in a subset of patients with TNBC is encouraging and needs to be validated in large prospective trials.

*Hematology-Oncology Division, Mayo Clinic Florida, Jacksonville, FL

Mayo Clinic Arizona, Scottsdale, AZ

Mayo Clinic, Rochester

§Duluth CCOP, Duluth, MN

Wichita CCOP, Wichita, KS

Conducted as a collaborative trial of the North Central Cancer Treatment Group (NCCTG) and Mayo Clinic and supported in part by Public Health Service grants CA-25224, CA-37404, CA-35269, and CA-35431 from the Department of Health and Human Services, National Cancer Institute. Additional research grants were provided by Amgen Inc.

The authors declare no conflicts of interest.

Reprints: Vivek Roy, MD, Hematology-Oncology Division, Mayo Clinic Florida, 4500 San Pablo Road, Jacksonville, FL 32224. E-mail:

© 2013 by Lippincott Williams & Wilkins, Inc