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A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00811135
First received: December 16, 2008
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Condition Intervention Phase
Breast Cancer
 Drug: capecitabine [Xeloda]
Drug: trastuzumab [Herceptin]
Drug: bevacizumab [Avastin]
 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, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Best overall response (% of patients with complete or partial response) [ Time Frame: Event driven;assessments made every 9-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival, overall survival, duration of response [ Time Frame: Event driven;assessments made every 9-12 weeks ] [ Designated as safety issue: No ]
  • Adverse events, cardiac events, laboratory tests [ Time Frame: Throughout study;assessments made every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: December 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 bid po on days 1-14 of each 3-week cycle
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
Drug: bevacizumab [Avastin]
15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles

  Eligibility

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • breast cancer with measurable locally recurrent or metastatic lesions;
  • candidate for chemotherapy;
  • HER2-positive disease;
  • ECOG PS of <=2.

Exclusion Criteria:

  • previous anticancer therapy for metastatic breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);
  • chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);
  • other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
  • uncontrolled hypertension or significant cardiovascular disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811135

Locations
Denmark
Herlev, Denmark, 2730
Vejle, Denmark, 7100
France
Aix En Provence, France, 13616
Beziers, France, 34525
Creteil, France, 94010
Dechy, France, 59187
Lormont, France, 33310
Marseille, France, 13285
Narbonne, France, 11108
Paris, France, 75012
Paris, France, 75651
Paris, France, 75970
Paris, France, 75010
Rodez, France, 12027
Saint Jean, France, 31240
Saint Quentin, France, 02321
Toulouse, France, 31076
Russian Federation
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
St Petersburg, Russian Federation, 197758
Slovakia
Bratislava, Slovakia, 831 01
Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08036
Madrid, Spain, 28041
Madrid, Spain, 28040
Malaga, Spain, 29010
Pontevedra, Spain, 36002
Salamanca, Spain, 37007
Sevilla, Spain, 41013
Valencia, Spain, 46010
Valencia, Spain, 46009
Sweden
Eskilstuna, Sweden, 63188
Sundsvall, Sweden, 85186
Uppsala, Sweden, 75185
Vaxjo, Sweden, 35185
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00811135     History of Changes
Other Study ID Numbers: MO21926, 2008-003283-20
Study First Received: December 16, 2008
Last Updated: April 29, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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 16, 2013