Tratamiento de pacientes con cáncer de mama metastático negativo para HER-2 que no han manifestado progresión durante el tratamiento de primera línea con docetaxel más bevacizumab. HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Initial treatment phase: 1. Signed informed consent obtained prior to initiation of any study specific procedures or treatment as confirmation of the patient?s awareness and willingness to comply with the study requirements 2. Age ? 18 years 3. Patients with histologically confirmed and documented, HER2-negative metastatic adenocarcinoma of the breast, who are candidates for taxane-based chemotherapy 4. Documented ER/PgR status 5. ECOG PS of 0-1; 6. Life expectancy of ? 12 weeks Maintenance treatment phase: 1. Patients must have SD, PR or CR per RECIST by the end of the initial treatment phase with bevacizumab plus docetaxel. Those patients who meet the response criteria at cycle 6 can be immediately randomised into the maintenance treatment phase (without needing to wait for results a confirmatory scan). Note: in the event that a patient is found to be responding at cycle 3 but is experiencing toxicities that would require a dose-interruption, investigators can use their discretion to immediately randomise the patient to the maintenance treatment phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy for mBC. Prior hormone therapy for metastatic disease is allowed. 2. Prior adjuvant/neoadjuvant chemotherapy within 6 m. prior to first study treatment administration. 3. Prior adjuvant/neoadjuvant anthracycline-based chemotherapy with a max. cumulative dose >360 mg/m2 for doxorubicin or >720 mg/m2 for epirubicin. 4. Prior radiotherapy for the treatment of metastatic disease. Radiotherapy administered for the relief of metastatic bone pain is allowed prior to study entry, as long as no more than 30% of marrow-bearing bone was irradiated. 5. Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day). 6. Requirement for concurrent use of the antiviral agent sorivudine, or chemically related analogues, such as brivudine. 7. Chronic daily treatment with corticosteroids (dose of ?10 mg/day methylprednisolone or equivalent), with the exception of inhaled steroids. 8. Current or recent treatment with another investigational drug or participation in another investigational study. 9. Inadequate bone marrow function: ANC: 1.5 x ULN for the institution ? AST/SGOT or ALT/SGPT >2.5 x ULN (>5 x ULN in patients with liver metastases) ? ALP >2.5 x ULN at baseline (>5 x ULN in patients with liver metastases, or >10 x ULN in patients with bone metastases). 11. Inadequate renal function, defined as: ? serum creatinine >1.5 x ULN ? creatinine clearance 2+. Patients with ?2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection and must demonstrate ?1g of protein in the 24-hour urine. 12. Patients not receiving anticoagulant medication who have an INR >1.5 or an aPTT >1.5 x ULN within 7 days prior to first study treatment. 13. Evidence of spinal cord compression or brain metastases. 14. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. 15. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. 16. Women of childbearing potential (defined as CTC grade 2. 21. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. 22. Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether maintenance therapy with bevacizumab plus capecitabine, compared to bevacizumab alone, can further increase Progression-Free Survival (PFS) in patients showing objective response or stable disease following initial therapy with bevacizumab plus docetaxel.;Secondary Objective: To evaluate the following parameters: During the initial treatment phase: ? Overall Response Rate (ORR) ? Clinical Benefit Rate (CBR) ? Safety and tolerability During the Maintenance treatment phase: ? ORR ? CBR ? Quality of life ? Time-to-Progression (TTP) ? Overall Survival (OS) ? Safety and tolerability;Primary end point(s): The primary efficacy variable is PFS, defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurs first. Progression will be based on tumour assessment made by the investigators according to the RECIST criteria. In this trial, PFS will be used to evaluate whether maintenance therapy with bevacizumab plus capecitabine compared to bevacizumab alone, further improves the response to treatment following initial therapy with bevacizumab plus docetaxel. | — |
Countries
France, Italy, Spain
Outcome results
None listed