A phase II study of Bevacizumab with Docetaxel and Capecitabine in the neoadjuvant setting for breast cancer patients

• Conditions: neoadjuvant treatment of patients with primary breast cancer and no distant metastases

• Registration Number: EUCTR2005-005883-10-AT
• Lead Sponsor: Roche Austria GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-04
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

?Female patients with histologic proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except T4d =inflammatory breast cancer) scheduled to receive preoperative chemotherapy.
?Age 18-70 years
?ECOG performance-status < 2
?No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix except curatively treated non melanoma skin cancer or in situ cervical cancer
?No distant disease/secondary carcinoma judged clinically and at least by chest X-ray, liver-sonography, and bone scan at the time of inclusion
?Normal cardiac function
?Results of the following assessments at the time of inclusion must be available:
- anamnesis and physical examination (within 4 weeks before enrolment)
- CT of thorax (within 4 weeks before enrolment)
- CT of abdomen (within 4 weeks before enrolment)
- bilateral Mammography (within 4 weeks before enrolment)
- histology
- grading
- hormone-receptor-status
- HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative)
?Laboratory requirements (within 1 week before enrolment):
(a) Hematology: Neutrophils * 4.0 x 109/l, Platelets * 150 x 109/l, Hemoglobin > 13 g/dl
(b) Hepatic function : Total bilirubin < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1x ULN, Alkaline phosphatases < 1 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
(c) Renal function : Creatinine < 1 x ULN
(d) Urinalysis: Urine dipstick of proteinuria < 2+. Patients discovered to have * 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate < 1 g of protein / 24 hours.
? Signed and dated Informed Consent before the start of specific protocol procedures
? If of childbearing potential, negative pregnancy test.

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

?Stage T4d/ inflammatory breast cancer
?Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation
?Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by WHO criteria
?Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
?Prior or concurrent systemic antitumor therapy
?Evidence of wound healing complications, bone fracture, ulcer or the presence of clinically significant peripheral vascular disease
?Clinically significant cardiac disease e.g. congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrythmias
?Other serious illness or medical condition
- history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- active uncontrolled infection
- unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
?Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
?Known hypersensitivity reaction to the compounds or incorporated substances.
?Known deficit of dihydropyrimidine-dehydrogenase (DPD)
?Evidence of bleeding diathesis or coagulopathy
?Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters.
?Ongoing treatment with aspirin (> 325mg / day) or other medications known to predispose to gastrointestinal ulceration.
?Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0 (patient must have recovered from any major injury), or anticipation of need for major surgical procedure during the course of the study.
?Treatment with an investigational drug within 30 days prior to study entry.
?Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study.
?Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of Avastin. Pathologic complete response rate will be measured.<br><br>;Secondary Objective: To evaluate the safety and toxicity of Avastin in combination with Docetaxel and Capecitabine given as preoperative therapy to breast cancer patients. Clinical objective response rate and rate of breast- conserving surgery will be measured.<br>;Primary end point(s): Pathologic complete response rate