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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964704
Recruitment Status : Withdrawn (No patients have been recruited therefore study has been cancelled)
First Posted : August 25, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bevacizumab [Avastin] Drug: capecitabine [Xeloda] Drug: docetaxel Drug: trastuzumab [Herceptin] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
Study Start Date : March 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single Arm Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks

Drug: capecitabine [Xeloda]
added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle

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

Drug: trastuzumab [Herceptin]
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Primary Outcome Measures :
  1. Progression-Free Survival on second-line treatment [ Time Frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter ]

Secondary Outcome Measures :
  1. Safety and tolerability: AEs, laboratory parameters, LVEF [ Time Frame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks ]
  2. Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival [ Time Frame: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00964704

Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00964704     History of Changes
Other Study ID Numbers: ML22056
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic