Phase 2
N=41
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003042 ↗Enrolled (actual)
41
Serious AEs
4.9%
Results posted
Apr 2021
Primary outcome: Primary: Three-year Relapse-free Survival — 61.5; 77.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); cisplatin (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); melphalan (Drug); mesna (Drug); paclitaxel (Drug); tamoxifen citrate (Drug); bone marrow ablation with stem cell support (Procedure); conventional surgery (Procedure); peripheral blood stem cell transplantation (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Three-year Relapse-free Survival |
61.5; 77.8 | — |
| PRIMARY Five-year Overall Survival |
69.2; 70.4 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin
- Diagnosis within the past 6 months
PATIENT CHARACTERISTICS:
Age:
- 60 and under
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGOT or SGPT no greater than 1.5 times the upper limit of normal
Renal:
- Creatinine less than 1.2 mg/dL
- Creatinine clearance at least 80 mL/min
- No history of hemorrhagic cystitis
Cardiovascular:
- Left ventricular fraction at least 55% on MUGA scan
- No previous valvular heart disease or arrhythmia
Pulmonary:
- FEV\_1 at least 60% predicted
- Room air pO\_2 greater than 85 mmHg
- Room air pCO\_2 no greater than 43 mmHg
- DLCO at least 60% of the lower limit of predicted value
Other:
- No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer
- No organic CNS dysfunction
- Not pregnant
- No known and potentially disabling psychosocial history
- Not positive for hepatitis B or HIV
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Stratum 1:
- No more than one cycle of chemotherapy
- Stratum 2:
- No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiation to the left chest wall
Surgery:
- Modified radical mastectomy allowed
Data sourced from ClinicalTrials.gov (NCT00003042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.