Estudio fase III randomizado de bevacizumab más capecitabina versus bevacizumab solo, como tratamiento de mantenimiento en pacientes con cáncer de mama metastático HER2-negativo que no hayan progresado durante el tratamiento de primera línea con docetaxel más bevacizumab .A randomized phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. - IMELDA

• Conditions: 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: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2008-006872-31-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 420

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

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 10E9/l, platelet count <100 x 10E9/l or haemoglobin <8 g/dl.
10. Inadequate liver function, defined as:
? serum (total) bilirubin >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 <50 ml/min (calculated according to Cockroft and Gault)
? urine dipstick for proteinuria >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 <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly).
17. Major surgical procedure within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
18. Minor surgical procedures, within 24 hours prior to the first study treatment.
19. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
20. Pre-existing peripheral neuropathy >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified