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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
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
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

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
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
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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