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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00002772
• Date of registration: 01/11/1999
• Primary sponsor: Southwest Oncology Group
• Public title: S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
• Scientific title: A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes
• Date of first enrolment: July 1996
• Target sample size: 602
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00002772
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Clifford A. Hudis, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

• Name: Antonio C. Wolff, MD
• Affiliation: Sidney Kimmel Comprehensive Cancer Center

• Name: Scott I. Bearman, MD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least
4 involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal
lymphatic involvement without clinical inflammatory changes (edema, peau d'orange,
erythema) allowed Must have undergone breast conserving surgery or modified radical
mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or
noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since
definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4
weeks of initial histologic diagnosis One breast meets the eligibility criteria Other
breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by
modified radical mastectomy or breast conserving surgery with axillary node dissection
Concurrent registration on S9719 Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance
status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at
least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status
required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular
ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a
cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No
second or third degree heart block or other serious cardiac conduction abnormality No
atrial or ventricular arrhythmia No requirement for medication known to affect cardiac
conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a
cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted
Other: HIV negative Hepatitis B surface antigen status required No serious medical or
psychiatric illness that would preclude informed consent or study participation No second
malignancy within the past 5 years except adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the
breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy:
No prior radiotherapy to the breast Surgery: See Disease Characteristics



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Biological: filgrastim

Drug: carboplatin

Drug: carmustine

Drug: cisplatin

Drug: cyclophosphamide

Drug: doxorubicin hydrochloride

Drug: paclitaxel

Drug: tamoxifen citrate

Drug: thiotepa

Procedure: autologous bone marrow transplantation

Procedure: peripheral blood stem cell transplantation

Radiation: radiation therapy

Secondary ID(s)

CDR0000064747

S9623

U10CA032102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)