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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

NCT ID: NCT00964704

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv every 3 weeks

capecitabine [Xeloda]

Intervention Type DRUG

added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle

docetaxel

Intervention Type DRUG

background therapy at time of disease progression, 100mg/m2 iv every 3 weeks

trastuzumab [Herceptin]

Intervention Type DRUG

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Interventions

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bevacizumab [Avastin]

15mg/kg iv every 3 weeks

Intervention Type DRUG

capecitabine [Xeloda]

added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle

Intervention Type DRUG

docetaxel

background therapy at time of disease progression, 100mg/m2 iv every 3 weeks

Intervention Type DRUG

trastuzumab [Herceptin]

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

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Austria

Other Identifiers

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2008-007495-20

Identifier Type: -

Identifier Source: secondary_id

ML22056

Identifier Type: -

Identifier Source: org_study_id