Phase 2
Completed N=72
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Source: ClinicalTrials.gov NCT00004092 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Five-Year Relapse-free Survival — 47; 55 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five-Year Relapse-free Survival |
47; 55 | — |
| SECONDARY Five-Year Overall Survival |
63; 75 | — |
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00004092). 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. Informational only — not medical advice.