Phase 2
N=112
S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00107276 ↗Enrolled (actual)
112
Serious AEs
4.2%
Results posted
Jun 2013
Primary outcome: Primary: Response Rate (Complete and Partial, Confirmed and Unconfirmed) — 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- capecitabine (Drug); cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Complete and Partial, Confirmed and Unconfirmed) |
29 | — |
| SECONDARY Progression-free Survival and Overall Survival |
5.9; 18.8 | — |
| SECONDARY Toxicity |
1; 1; 2; 2; 1; 2 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV breast cancer
- Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)
- Meets 1 of the following criteria:
- Measurable disease
- Non-measurable disease
- MUC-1 antigen level > 2 times upper limit of normal AND level has increased by 1.5 times
- Must have documented MUC-1 antigen level
- Either cancer antigen (CA) 15-3 or CA 27-29 allowed
- Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)
- No symptomatic brain or CNS metastases
- Previously treated brain or CNS metastasis allowed provided radiotherapy was completed ≥ 8 weeks before study entry
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- No known existing uncontrolled coagulopathy
Hepatic
- Not specified
Renal
- Creatinine clearance > 40 mL/min
Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No cardiac arrhythmia not well controlled with medication
- No myocardial infarction within the past 12 months
- No other clinically significant cardiac disease
Gastrointestinal
- Able to take oral medication
- No uncontrolled nausea, vomiting, or diarrhea
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infection requiring systemic therapy
- No prior severe reaction to fluoropyrimidines
- No known sensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy or biologic therapy for breast cancer
- No concurrent gene therapy for breast cancer
- No concurrent filgrastim (G-CSF)
Chemotherapy
- At least 14 days since prior chemotherapy and recovered
- No more than 2 prior chemotherapy regimens for metastatic disease
- No prior capecitabine for metastatic disease
- No prior oral cyclophosphamide for metastatic disease
- Prior IV cyclophosphamide allowed
- No other concurrent chemotherapy for breast cancer
Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy for breast cancer
Radiotherapy
- See Disease Characteristics
- At least 14 days since prior radiotherapy to non-CNS disease sites and recovered
- No concurrent radiotherapy for breast cancer
Surgery
- Not specified
Other
- Concurrent bisphosphonates allowed
- No concurrent full-dose warfarin
- Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed
- No other concurrent antineoplastic therapy for breast cancer
Data sourced from ClinicalTrials.gov (NCT00107276). 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.