A single arm, open-label, multicentre, phase II study to evaluate the efficacy and safety of bevacizumab and trastuzumab combination and sequential capecitabine in patients with HER2-positive locally recurrent or metastatic breast cancer after early relapse to adjuvant trastuzumab-containing therapy

Roche Austria GmbH0 sitesFebruary 24, 2009

ConditionsMale or female patients with locally recurrent or metastatic HER2-positive breast cancer who have relapsed early after adjuvant treatment that included trastuzumab and who have not received prior chemotherapy for their locally recurrent or metastatic disease MedDRA version: 9.1Level: HLGTClassification code 10006291Term: Breast neoplasms malignant and unspecified (incl nipple)

DrugsHerceptin Avastin Xeloda

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Male or female patients with locally recurrent or metastatic HER2-positive breast cancer who have relapsed early after adjuvant treatment that included trastuzumab and who have not received prior chemotherapy for their locally recurrent or metastatic disease
Sponsor: Roche Austria GmbH
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 24, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Roche Austria GmbH

Eligibility Criteria

Inclusion Criteria

•1\.Male or female, age \= 18 years.
•2\.Pathologically confirmed breast adenocarcinoma with measurable (per RECIST, see Appendix 2\) or non\-measurable, locally recurrent or metastatic lesions.
•3\.Documented HER2 protein overexpression as determined by immunohistochemistry (IHC) 3\+ or by demonstrated HER2/c\-erbB2 gene amplification according to fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) of the primary tumor by a local or central laboratory.
•4\.Candidates for chemotherapy. Locally advanced disease must not be amenable to resection with curative intent.
•5\.Most recent prior systemic treatment for breast cancer was adjuvant therapy that included trastuzumab. Disease progression must have occurred during adjuvant treatment or up to 12 months from completion of adjuvant treatment. Radiotherapy may have been received after adjuvant therapy, however patients should have recovered from any acute reversible toxicity.
•6\.LVEF \= 55% measured by either echocardiography or multiple gated nuclear angiography (MUGA) within 6 weeks of study treatment initiation.
•7\.ECOG Performance Status \= 1
•8\.Able and willing to comply with the protocol.
•9\.Written informed consent, obtained prior to beginning any study\-specific procedures.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\.Previous treatment for locally advanced or metastatic breast cancer other than radiotherapy. Patients must have fully recovered from side effects of any prior radiotherapy.
•2\.Prior treatment with bevacizumab or capecitabine.
•3\.Prior neoadjuvant or adjuvant treatment with anthracyclines if the maximum cumulative dose was greater than 360 mg/m2 of doxorubicin or 720 mg/m2 of epirubicin.
•4\.Chronic daily treatment with corticosteroids (dose of \> 10 mg/day methylprednisolone equivalent) excluding inhaled steroids.
•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\.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or anticipation of the need for major surgery during the course of the study treatment.
•8\.Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study.
•13\.Other primary malignancy which could affect compliance with the protocol or interpretation of results. Patients treated with curative intent and disease\-free for at least 5 years and patients treated curatively for carcinoma in situ of the cervix or non\-melanomatous skin cancer may be included.
•14\.Evidence of CNS metastasis. If there is any clinical suspicion of brain metastasis, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the brain must be conducted within 4 weeks prior to enrolment.