A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: docetaxel; Drug: trastuzumab [Herceptin]

• Registration Number: NCT00964704
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2011-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• male or female patients, age >/=18 years
• locally recurrent or metastatic HER2-positive breast cancer
• disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
• LVEF >/=55% at baseline

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Exclusion Criteria

• prior treatment with bevacizumab or capecitabine
• anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
• chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
• clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
• evidence of spinal cord compression or CNS metastasis
• history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	capecitabine [Xeloda]	-
Single Arm	bevacizumab [Avastin]	-
Single Arm	trastuzumab [Herceptin]	-
Single Arm	docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival on second-line treatment	event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability: AEs, laboratory parameters, LVEF	throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival	event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter