Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Physiologic age 60 or under	NCI	CHNMC-IRB-98096 IRB 98096, CHNMC-PHII-18, NCI-H99-0038, NCT00004092

Objectives

1. Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I closed to accural as of 4/6/2006.)
2. Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients.
3. Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after high-dose chemotherapy in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis
  • Stage II with at least 10 positive axillary nodes

    OR

  • Stage IIIA or IIIB



• No histologically proven bone marrow metastasis



• No CNS metastasis



• Hormone receptor status:
  • Hormone receptor status known

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy
• No prior doxorubicin of total dose exceeding 240 mg/m²
• No prior paclitaxel of total dose of at least 750 mg/m²
• No more than 12 months since prior conventional-dose adjuvant chemotherapy

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy
• No prior radiation to the left chest wall

Surgery:

• Not specified

Patient Characteristics:

Age:

• Physiological age 60 or under

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT or SGPT no greater than 2 times upper limit of normal
• Hepatitis B antigen negative

Renal:

• Creatinine no greater than 1.2 mg/dL
• Creatinine clearance at least 70 mL/min
• No prior hemorrhagic cystitis

Cardiovascular:

• Ejection fraction at least 55% by MUGA
• No prior significant valvular heart disease or arrhythmia

Pulmonary:

• FEV₁ at least 60% of predicted
• pO₂ at least 85 mm Hg on room air
• pCO₂ at least 43 mm Hg on room air
• DLCO at least 60% lower limit of predicted

Other:

• No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix
• No CNS dysfunction that would preclude compliance
• HIV negative
• No sensitivity to E. coli-derived products
• Not pregnant
• Fertile patients must use effective contraception

Expected Enrollment

A total of 100 patients will be accrued for this study within 3 years.

Outcomes

Disease-free survival
Incidence of grade IV toxicity

Overall survival
Treatment-related mortality
Time to engraftment
Time to platelet independence
Reduction in the degree of developing osteoporosis
Toxicity profile
Incidence of novel clonal hematopoietic abnormalities

Outline

This is a randomized study. Patients are stratified by stage of disease.

Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.

All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)

• Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.



• Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.

Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.

Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.

Trial Contact Information

Trial Lead Organizations

City of Hope Comprehensive Cancer Center

Clinical Trials Office - New Patient Services		Ph: 800-826-4673

Registry Information
Official Title		Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients with High-Risk Primary Breast Cancer
Trial Start Date		1999-05-26
Trial Completion Date		2008-11-06
Registered in ClinicalTrials.gov		NCT00004092
Date Submitted to PDQ		1999-08-31
Information Last Verified		2008-11-06
NCI Grant/Contract Number		CA33572, CA63265

Back to Top