Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00545077|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole Drug: Bevacizumab Drug: Fulvestrant||Phase 3|
The main endpoint of the study is progression-free survival (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.
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:
- Estrogen Receptor (ER)+ / Progesterone Receptor (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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Randomized Trial to Evaluate Efficacy and Safety of Bevacizumab in Combination With Endocrine Treatment vs Endocrine Alone, in Postmenopausal With Advanced or Metastatic Cancer With Indication of Hormonotherapy as First-line|
|Actual Study Start Date :||November 6, 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||July 24, 2014|
Active Comparator: Arm A: Endocrine Therapy (ET)
Endocrine treatment consisting of either letrozole or fulvestrant. 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.
Other Name: Femara
Other Name: Faslodex
Experimental: Arm B: ET with Bevacizumab (ET-B)
Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 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.
Other Name: Femara
Other Name: Avastin
Other Name: Faslodex
- Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]PFS was defined as the time elapsed from randomization until the date in which the progression of the disease or the death for any reason (whichever occurs first) is documented.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]OS was defined as the time elapsed since randomization, until the time in which death occurs for any reason. The patients lost in the follow-up will be censured at the date of the last follow-up.
- Time to Treatment Failure (TTF) [ Time Frame: Up to 2 years ]TTF was defined as the time elapsed since randomization until the date the treatment is discontinued for any reason (progression disease, treatment toxicity or death).
- Overall Response Rate (ORR) [ Time Frame: 2 years ]ORR to treatment is reflected by a frequency table containing the data of the best overall response (Complete Response, Partial Response,Stable Disease or Progressive Disease) experienced for each patient during treatment (recorded from the start of the treatment until disease progression) per arm.
- Response Duration (RD) [ Time Frame: Up to 2 years ]RD was defined as the time elapsed from when a partial or complete response is verified until the time in which progression or death occurs.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 2 years ]CBR was defined as the percentage of patients achieving a Complete Response (CR), a Partial Response (PR) or a stabilization of the disease (SD) > 6 months: the response will be evaluated according to the RECIST criteria. In the patients without measurable disease at the baseline time, the clinical benefit will be defined as the absence of progression > 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545077
|Study Director:||Study Director||GBG Forschungs GmbH|
|Study Director:||Study Director||Hospital San Carlos, Madrid|
|Study Director:||Study Director||Hospital Provincial de Córdoba|