Clinical trial · Interventional
S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
NCT00107276CI-TRIAL-00011403completedPhase 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, 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cyclophosphamide and capecitabine
- description
- cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
- interventionNames
- Drug: capecitabine
- Drug: cyclophosphamide
Primary outcomes (1)
- measure
- Response Rate (Complete and Partial, Confirmed and Unconfirmed)
- timeFrame
- Patients assessed at least every six weeks while on protocol treatment
- description
- Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.