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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

This study has been withdrawn prior to enrollment.
(No patients have been recruited therefore study has been cancelled)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00964704
First received: August 21, 2009
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: trastuzumab [Herceptin]
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival on second-line treatment [ Time Frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability: AEs, laboratory parameters, LVEF [ Time Frame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: trastuzumab [Herceptin]
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964704

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00964704     History of Changes
Other Study ID Numbers: ML22056, 2008-007495-20
Study First Received: August 21, 2009
Last Updated: May 23, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Capecitabine
Bevacizumab
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013