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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 287

Inclusion Criteria

Initial treatment phase:
1. Female patients aged = 18 years
2. Patients with histologically confirmed and documented, HER2-negative metastatic adenocarcinoma of the breast, who are candidates for taxane-based chemotherapy
3. Documented ER/PgR status
4. ECOG PS of 0-1;
5. 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

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. Inadequate bone marrow function
7. Inadequate liver function
8. Inadequate renal function
9. Pregnant or lactating females.
10. Women of childbearing potential not using effective, non-hormonal means of contraception.
11. 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.
12. Minor surgical procedures, within 24 hours prior to the first study treatment.
13. 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.
14. Pre-existing peripheral neuropathy >CTC grade 2.
15. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
16. Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke within =6 months prior to the first study treatment, myocardial infarction within =6 months prior to the first study treatment, unstable angina, NYHA grade II or greater CHF, or serious cardiac arrhythmia requiring medication.
17. History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra-abdominal abscess within 6 months prior to randomisation.
18. Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications.
19. Serious non-healing wound, peptic ulcer or bone fracture.
20. Serious active infection requiring i.v. antibiotics at enrolment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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