Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
NCT00004092CI-TRIAL-00018749completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ACT) (closed to accrual as of 4/6/2006)
- description
- 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.
- interventionNames
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: paclitaxel
- Procedure: peripheral blood stem cell transplantation
- type
- ACTIVE_COMPARATOR
- label
- Arm II (STAMP V)
- description
- 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.
- interventionNames
- Biological: filgrastim
- Drug: carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
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 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/mm\^3 * Platelet count at least 100,000/mm\^3 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: * FEV\_1 at least 60% of predicted * pO\_2 at least 85 mm Hg on room air * pCO\_2 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy * No prior doxorubicin of total dose exceeding 240 mg/m\^2 * No prior paclitaxel of total dose of at least 750 mg/m\^2 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.