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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Capecitabine; Drug: Bevacizumab

• Registration Number: NCT00121836
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-18
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-16
• Results First Submitted QC: 2011-02-10
• Results First Posted: 2011-03-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-25
• Last Update Posted: 2011-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Capecitabine	-
1	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	approximately 505 days (Median Time to Death)	Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	Throughout study	The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.; Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.
Premature Withdrawal From Study Due to Adverse Events	Throughout study	The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.
Number of Participants With Marked Laboratory Abnormalities	until progressive disease or for up to 3 years	The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in \>= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.