None listed
Conditions
Interventions
Adjuvant chemotherapy based on evidence, containing an anthracycline ± a taxane or a taxane alone.
Group name:Arm 2 Type of group
1 year of treatment with bevacizumab, beginning simultaneously with one of the evidence-based adjuvant chemotherapy regimens, containing an anthracycline ± a taxane or taxanes alone
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 • Patients must be at least 18 years old • The patient must have a clinical status 0 or 1 on the ECOG scale • The patient must have presented an operable primary invasive adenocarcinoma of the breast. Patients with multifocal and simultaneous bilateral malignant tumors are eligible • 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. Aunt - T3 • The triple negative phenotype must have been confirmed in a central laboratory • The pathological examination of the axillary nodes should reveal a) disease with positive nodes (pNla, pN2a or pN3a) or b) disease with negative nodes (pNO) • Imaging studies of the chest, abdomen and, if applicable, of bones, performed within 3 months prior to randomization should not reveal the presence of distance dissemination. • The specific criteria of the 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 recurrences for less than 5 years before randomization • 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 a diastolic pressure> 90 mm Hg, with or without antihypertensive medication. Patients with initial blood pressure elevations are eligible if, when starting to take antihypertensive medication or when adjusting the doses, the pressure decreases until the admission criteria are met. • History of transient ischemic attacks (TIA) or stroke (CVA) • If the risk of developing venous thromboembolism outweighs the benefits of participating in the study. • Patients being treated with a therapeutic dose of an anticoagulant for 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 under investigation 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 • Forecast the need for major surgery procedures (other than the breast operation required) during the course of the study • Unhealed wounds or skin ulcers, or bone fractures welded in an Incomplete form • Recent history (ie, within 6 months prior to randomization) of an abdominal fistula, including any other non-GI grade 4 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 within one year of entering menopause, as well as male patients who are not willing to accept the use of an effective non-hormonal contraceptive method during the treatment period and for at least 6 months after the last dose of bevacizumab. • Current or recent treatment (within 30 days prior to randomization) with another drug under inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is a compound assessment criterion, which is defined as the time elapsed from randomization to the date of the first occurrence of any of the following events: Homolateral invasive breast cancer recurrence, Local-regional recurrence of invasive breast cancer, Recurrence distant, Death attributable to any cause, Contralateral invasive breast cancer, Second invasive primary non-breast cancer Measure:Survival Without Invasive Disease (SSEI) Timepoints:From the date of randomization until the events appear | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the time elapsed from randomization to death attributable to any cause. Measure:Overall Survival Timepoints:During the study ; Outcome name:defined as the time elapsed from randomization to the date of the first occurrence of one of the following events: a) a homolateral local / regional recurrence of invasive breast cancer or a distant breast cancer recurrence (according to the primary endpoint) b) a contralateral invasive breast cancer c) a homolateral or contralateral DCIS d) only death from breast cancer Measure:Breast Cancer Free Interval Timepoints:During the study ; Outcome name:defined as the time elapsed from randomization to the date of the first occurrence of one of the following events: a) any of the events specified according to the primary assessment criteria or b) a new diagnosis of a homolateral or contralateral DCIS Measure:Survival Without Disease Timepoints:During the study ; Outcome name:Defined as the time elapsed from randomization to the date of the first occurrence of one of the following events: a) a distant recurrence b) death attributable to any cause c) a second invasive primary non-breast cancer (except non-melanoma skin cancer) Measure:Survival Without Distance Disease Timepoints:During the study | — |
Countries
Czech Republic, Finland, France, Greece, Italy, Netherlands, Peru, Poland, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed