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Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


18 and older




- 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



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- No known existing uncontrolled coagulopathy


- Not specified


- Creatinine clearance > 40 mL/min


- 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


- Able to take oral medication

- No uncontrolled nausea, vomiting, or diarrhea

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome


- 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


Biologic therapy

- No concurrent immunotherapy or biologic therapy for breast cancer

- No concurrent gene therapy for breast cancer

- No concurrent filgrastim (G-CSF)


- 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


- See Disease Characteristics

- At least 14 days since prior radiotherapy to non-CNS disease sites and recovered

- No concurrent radiotherapy for breast cancer


- Not specified


- 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

Gender: Female
Steward Physician(s)
  • Anne F. Schott, MD
  • Kathy S. Albain, MD
  • Holy Family Hospital - Completed
Trial Interventions
  • capecitabine
  • cyclophosphamide
Physician Researcher

Investigator Name:

  • Anne F. Schott, MD
  • Kathy S. Albain, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00107276
Volunteers:  Not Accepting Healthy Volunteers

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