Advanced triple negative breast cancer MedDRA version: 13.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Roche Products Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to any study specific procedure. 2. Age =18 years. 3. Histologically confirmed, triple-negative (ER-/PgR-/HER2-) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease. 4. Patient who in Investigator’s opinion requires combination therapy for their disease. 5. Performance status (PS) =60 measured by Karnofsky score (similar to ECOG PS 0-2). 6. Life expectancy of =12 weeks. 7. Prior adjuvant chemotherapy is allowed. 8. Prior radiation therapy is allowed if: • delivered in the adjuvant setting as a part of the treatment of early breast cancer • delivered for the relief of metastatic bone pain, provided that no more than 30% of marrow-bearing bone has been irradiated. 9. Adequate haematological function • Absolute neutrophil count (ANC) =1.5 x 109/L AND • Platelet count =100 x 109/L AND • Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level). 10. Adequate liver function • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy for metastatic breast cancer. 2. Patients currently undergoing radiation therapy for the treatment of metastatic disease (apart from therapy for the relief of metastatic bone pain). 3. Pre-existing peripheral neuropathy NCI CTC-AE Grade >2. 4. Major surgery (including open biopsy) or significant traumatic injury within 28 days prior to enrolment, or anticipation of the need for major surgery during study treatment. 5. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. 6. Current or recent (within 10 days) use of aspirin (>325 mg/day). 7. Current or recent (within 10 days) use of full-dose anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed. 8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. 9. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg). 10. Active cardiovascular disease =6 months before enrolment, e.g. CVA or myocardial infarction, or unstable angina or congestive heart failure NYHA Class =II not controlled by medication. 11. History of thrombotic disorders within the six months prior to enrolment. 12. Non-healing wound, active peptic ulcer or bone fracture. 13. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to enrolment. 14. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception during the study and 6 months after the last dose of bevacizumab. 15. Known hypersensitivity to bevacizumab or any of its excipients or paclitaxel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability and safety profile of bevacizumab when combined with weekly paclitaxel as first line treatment of metastatic triple negative breast cancer.;Secondary Objective: Efficacy of bevacizumab combined with weekly paclitaxel, as measured by TTP and OS. Efficacy will also be assessed according to patients' performance status on the Karnofsky scale.;Primary end point(s): The primary endpoint is the incidence of all serious and non-serious adverse events (irrespective of their relatedness) during the study. Results of the FACT-B and EQ-5D Quality of Life questionnaires. | — |
Countries
United Kingdom
Outcome results
None listed