Phase 4 N=109 Treatment

A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00121836 ↗

Enrolled (actual)

109

Serious AEs

35.8%

Results posted

Mar 2011

Primary outcome: Primary: Overall Survival — 505 Days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Capecitabine (Drug); Bevacizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hoffmann-La Roche
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	505	—
SECONDARY Number of Subjects With Adverse Events	108; 54; 104; 51; 82; 41	—
SECONDARY Premature Withdrawal From Study Due to Adverse Events	25; 37; 4; 7; 2; 6	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities	16; 18; 9; 15; 23; 14	—

Summary

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.

Eligibility Criteria

Inclusion Criteria

Women >=18 years of age
HER2-negative metastatic breast cancer
Previous adjuvant chemotherapy or hormonal treatment
>=1 measurable target lesion

Exclusion Criteria

Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
Central nervous system metastases
Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
Serious concurrent infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00121836). 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.