Locally advanced or metastatic breast cancer in postmenopausal women with negative Human Epidermal Growth Factor Receptor 2 (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 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) * PFS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Progression-free Survival (PFS)
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.
Time frame: Up to 2 years
Overall Survival (OS)
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 frame: Up to 2 years
Time to Treatment Failure (TTF)
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).
Time frame: Up to 2 years
Overall Response Rate (ORR)
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.
Time frame: 2 years
Response Duration (RD)
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.
Time frame: Up to 2 years
Clinical Benefit Rate (CBR)
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.
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Time frame: Up to 2 years