Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line Treatment in Postmenopausal Patients With Advanced or Metastatic Breast Cancer
Locally advanced or metastatic breast cancer in postmenopausal women with negative HER2, who are candidates for hormone treatment and who have not received previous chemotherapy or hormonotherapy for the metastatic disease.
The main endpoint of the study is PFS. It has been calculated that 378 patients will need to be included, according to the following assumptions:
- Recruitment period of 21 months.
- Minimum follow-up period of 9 months.
- PFS of 9 months in the control arm (letrozole in monotherapy). Using a two-sided log-rank test, for a 5% α level, 344 patients (172 in each treatment arm) will be required for 270 events to occur, which will provide an 80% power for detecting a hazard ratio of 0.69 (corresponding to a PFS median of 13 months in the bevacizumab arm). This sample size has been adjusted for an intermediate analysis when 2/3 of the total of required events have occurred. This intermediate analysis can be avoided if, at the time in which it must be carried out, it is estimated that the final analysis will be carried out in 4 months.
Taking into account a 10% percentage of losses, 378 patients are expected to be included in the study.
An intermediate safety evaluation will be carried out when 63 patients have finished their treatment in each treatment arm.
|Breast Cancer||Drug: Endocrine treatment consisting of either letrozole or fulvestrant. Drug: Bevacizumab + Endocrine treatment consisting of either letrozole or fulvestrant.||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Endocrine Treatment Compared to Endocrine Treatment Alone, in Postmenopausal Women With Advanced or Metastatic Cancer With Indication of Hormonotherapy as First-line Treatment|
- ·To compare the progression-free survival (PFS) between both treatment arms. [ Time Frame: 2 years ]
- · Overall survival (OS) · Time to treatment failure (TTF) · Better response to treatment (RR) · Response duration (RD) · Clinical benefit proportion (CBP = CR + PR + SD > 6 months) · Safety and tolerance [ Time Frame: 2 years ]
|Study Start Date:||November 2007|
|Study Completion Date:||January 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: A
• Endocrine treatment consisting of either letrozole or fulvestrant.The patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.
Drug: Endocrine treatment consisting of either letrozole or fulvestrant.
The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.
Bevacizumab: 15 mg/Kg i.v. on day 1 every 3 weeks plus Endocrine treatment consisting of either letrozole or fulvestrant.
Drug: Bevacizumab + Endocrine treatment consisting of either letrozole or fulvestrant.
Bevacizumab will be administered every 21 days (day 1 of cycle 2 will be day 22 of the treatment.The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent. Those patients in treatment with bevacizumab who end the study without having progressed will continue to receive the drug out of the study.
A multicenter, randomized phase III clinical trial. After verifying the selection criteria, the patients will be randomized to receive letrozole alone or in combination with bevacizumab. Before randomization, the patients will be stratified according to the following prognosis factors:
- ER+/PgR+ vs the other options (ER+/PgR- vs ER-/PgR+)
- Previous adjuvant hormonotherapy (yes/no)
- Status: locally advanced vs metastatic.
- Measurable vs non measurable disease
- Visceral disease (yes/no)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545077
Show 85 Study Locations
|Study Director:||Sibylle Loibl, PhD., MD.||GBG Forschungs GmbH|
|Study Director:||Miguel Martín, PhD., MD||Hospital Clínico San Carlos|
|Study Director:||Juan De la Haba, PhD., MD.||Hospital Provincial de Córdoba|