None listed
Conditions
Interventions
Bevacizumab administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient + Standard adjuvant chemotherapy. All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Group name:Arm A Type of group
Standard adjuvant chemotherapy. All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • All patients must have signed and dated an informed consent form • Must be at least 18 years old • The patient must have a clinical status (performance status) 0 or 1 on the BCOG scale • The patient must have presented an operable primary invasive carcinoma of the breast. • The definitive local-regional surgery has been performed • The interval between the last local-regional operation (including the new removal of affected surgical margins) and randomization should be between 4 and 11 weeks. • The primary tumor must be identified and be, by clinical and pathological evaluation, Tla-T3 • Central laboratory tests of the primary invasive tumor must confirm the negativity for HER2 and the expression of the endocrine receptor (ER and PgR) must be negative (ie a total Allred score of O or 2) or low (ie, a total Allred score of 3). • The pathological examination of the axillary nodes must reveal disease with positive nodes (pNla, pN2a or pN3a) OR disease with negative nodes (pN0) • Imaging studies of the chest, abdomen and, if applicable, bones, performed within 3 months prior to randomization do not reveal evidence of distance dissemination • Specific criteria of organs (according to the local laboratory) must be met as a guarantee of the evidence of adequate organic function, within 7 days prior to randomization.
Exclusion criteria
Exclusion criteria: • Patients with T4 tumors (which include inflammatory carcinomas and tumors with direct extension to the chest wall or directly affecting the skin) • Patients in whom the surgeon was not able to surgically release the axilla from all gross disease / Presence of microscopic extracapsular extension clearly visible in lymph nodes • History of breast cancer, including DCIS. (Patients with a history of CLIS are eligible) • Any previous malignant tumor treated with the intention of curing, of which the patient has not had relapses for less than 5 years before randomization; Exceptions are: carcinoma in situ of the cervix, flat cell carcinoma of the skin or basal cell carcinoma of the skin • Any previous systemic chemotherapy to treat any malignant tumor, or an antiangiogenic treatment that modifies the molecular pathway of the FCEV. Prior chemotherapy for a non-malignant disease should be analyzed with a member of the medical support team. • Patients who are receiving chemoprophylaxis with any hormonal agent, such as raloxifene, tamoxifen or other SERMs, and are not willing to stop these medications before entering the study. • Clinically significant heart disease • Uncontrolled hypertension, defined by a systolic pressure> 150 mm Hg and / or EXCLUSION a diastolic pressure> 90 mm Hg, with or without antihypertensive medication. The (cont.) Patients with initial blood pressure elevations are eligible if when starting to take hypertensive medication or when adjusting the doses the pressure decreases until the admission criteria are met. • History of transient ischemic attacks (TIA) or stroke (CVA). • The risk of developing venous thromboembolism outweighs the benefits of participating in the study. • Patients being treated with a therapeutic dose of an anticoagulant due to venous thromboembolism (eg, deep vein thrombosis or pulmonary embolism). • History or evidence of hemorrhagic diathesis or hereditary coagulopathy with risk of bleeding • Gastroduodenal ulcer (s), demonstrating activity by endoscopy • Patients with an infection that requires intravenous antibiotics at the time of randomization • Patients with any other disease, metabolic or psychological, or who have any evidence during the physical examination or in special investigations (including a laboratory finding) that generates a reasonable suspicion that there is a disease or condition that causes the use of the drug In research it is contraindicated, or it may affect the fulfillment of the study requirements by the patient, or it may increase the patient´s risk of suffering possible complications from the treatment. • Pregnant or breastfeeding women. • Invasive procedures within 28 days prior to randomization, defined as follows: major surgery procedure, open pit biopsy or major traumatic injury (the placement of a vascular access device is not considered a major surgery procedure ) • Forecast the need for major surgery procedures (other than the breast operation required) during the course of the study 19. Unhealed wounds, skin ulcers or incompletely welded bone fracture • Recent history (ie, within 6 months of randomization) of an abdominal fistula, including any other grade 4 non-GI fistula, GI perforation or intra-abdominal abscess • Patients who require continuous daily treatment with aspirin (> 325 mg / day) or clopidogrel (> 75 mg / day) • Women with the ability to procreate, female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. Measure:Time to Invasive Disease-free Survival (IDFS) Event Timepoints:Event driven (until data cutoff: 29 February 2012: up to 49 months) ; Outcome name:IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented. Measure:Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Timepoints:Event driven (until data cutoff: 29 February 2012 up to 49 months) ; Outcome name:IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Co | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive. Measure:Time to Overall Survival (OS) Event Timepoints:Event driven (until data cutoff: 30 June 2014: up to 77 months) ; Outcome name:OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive. Measure:Percentage of Participants With Overall Survival (OS) Event Timepoints:Event driven (until data cut off: 29 February 2012: up to 49 months) ; Outcome name:OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive. Measure:Percentage of Participants With Overall Survival (OS) Event Timepoints:Event driven (until data cut off: 30 June 2014: up to 77 months) ; Outcome name:BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause. Measure:Time to Breast Cancer-Free Interval (BCFI) Event Timepoints:Event driven (until data cutoff: 29 February 2012: up to 49 months) ; Outcome name:BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ips | — |
Countries
Austria, Czech Republic, Finland, France, Germany, Greece, Italy, Netherlands, Peru, Poland, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactGabriela Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed