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

Hoffmann-La Roche109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Breast Cancer

Interventions

CapecitabineDRUG

1000 mg/m² PO BID on Days 1-15 of each 3-week cycle

BevacizumabDRUG

15 mg IV on Day 1 of each 3-week cycle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (57)

Outcomes

Primary Outcomes

Overall Survival

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

Time frame: approximately 505 days (Median Time to Death)

Secondary Outcomes

Number of Subjects With Adverse Events

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.

Time frame: Throughout study

Premature Withdrawal From Study Due to Adverse Events

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.

Time frame: Throughout study

Number of Participants With Marked Laboratory Abnormalities

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.

Time frame: until progressive disease or for up to 3 years

Data from ClinicalTrials.gov

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