Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002942
• Date of registration: 01/11/1999
• Primary sponsor: Comprehensive Cancer Center of Wake Forest University
• Public title: Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer
• Scientific title: Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Therapy in Poor Prognosis Breast Cancer
• Date of first enrolment: June 1996
• Target sample size: 136
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002942
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David D. Hurd, MD
• Affiliation: Comprehensive Cancer Center of Wake Forest University

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the
breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including
poorly differentiated histology, high mitotic rate, hormone receptor negative, high S
phase) with at least three involved axillary lymph nodes, estimated five year relapse free
survival rate less than 50%, and does not qualify for higher priority protocol treatments
No central nervous system involvement

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life
expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3
Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT
or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum
creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60
mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or
severe cardiovascular disease, including recent myocardial infarction, congestive heart
failure, angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and
spirometry at least 50% of predicted Other: Not HIV positive Not HBsAG positive Not
pregnant Must have functioning central venous catheter No active infection No uncontrolled
diabetes mellitus No other prior malignancy except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II
cancer from which the patient is currently in complete remission, or any other cancer from
which the patient has been disease free for at least 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support
Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Procedure: autologous bone marrow transplantation

Procedure: peripheral blood stem cell transplantation

Secondary ID(s)

CCCWFU-95496

CDR0000065391

NCI-G97-1145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)