S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.

Timeline

Start

1996-07

Primary completion

2004-02

Completion

2004-02

Outcome

Missed primary endpoint

Stopped (Enrollment): “poor accrual”

paper Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). PMID 17404368 ↗

Publications

• Results Moore HC, Green SJ, Gralow JR, Bearman SI, Lew D, Barlow WE, Hudis C, Wolff AC, Ingle JN, Chew HK, Elias AD, Livingston RB, Martino S; Southwest Oncology Group/Intergroup Study 9623. Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623. J Clin Oncol. 2007 May 1;25(13):1677-82. doi: 10.1200/JCO.2006.08.9383. Epub 2007 Apr 2.
• Results Bearman SI, Green S, Gralow J, et al.: SWOG/Intergroup 9623: a phase III comparison of intensive sequential chemotherapy to high dose chemotherapy and autologous hematopoietic progenitor cell support (AHPCS) for primary breast cancer in women with =4 involved axillary lymph nodes. [Abstract] J Clin Oncol 23 (Suppl 16): A-572, 21s, 2005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Cyclophosphamide	Other / unclassified	—	Intravenous
Subject	Doxorubicin	Other / unclassified	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous
Subject	Thiotepa	Other / unclassified	—	Intravenous
Subject	carmustine	Small molecule	—	Intravenous
Background	Tamoxifen	Small molecule	—	Oral
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous

Indications