Open-Label study of bevacizumab (Avastin®) and taxane monotherapy for the first-line treatment of patients with advanced triple-negative breast cancer - BATMA
- Conditions
- Advanced triple negative breast cancerMedDRA version: 13.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-014279-37-GB
- Lead Sponsor
- Roche Products Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
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 <1.5 x upper limit of normal (ULN) AND
• AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases.
11. Adequate renal function
• Serum creatinine =1.25 x ULN or calculated creatinine clearance =50 mL/min AND
• Urine dipstick for proteinuria <2+. Patients with =2+ proteinuria on dipstick should have a 24 hour urine collection and must show =1 g of protein in 24 hours.
12. International normalised ratio (INR) =1.5 and partial prothrombin time (PTT or aPTT) =1.5 x ULN within 7 days prior to enrolment.
13. Patients should not be pregnant or breast-feeding. Women of child-bearing potential (i.e. a woman who is capable of becoming pregnant) must have a negative serum or urine pregnancy test within 7 days prior to first dose of bevacizumab. Patients must agree to use contraception throughout the study and for 6 months after the last dose of bevacizumab. Women must discontinue breast-feeding during therapy and not breast feed for at least 6 months following the last dose of Avastin.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Results of the FACT-B and EQ-5D Quality of Life questionnaires.
- Secondary Outcome Measures
Name Time Method