A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00391092
First received: October 20, 2006
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Herceptin
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: (36 months after randomization of last patient) ] [ Designated as safety issue: No ]
  • Best overall response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • QoL, AEs, targeted events including CHF, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 424
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Drug: Docetaxel
100mg/m2 iv every 3 weeks
Active Comparator: 2 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Drug: Docetaxel
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:

  • adult patients, >=18 years of age;
  • HER2 positive breast cancer with locally recurrent or metastatic lesions;
  • eligible for chemotherapy;
  • baseline LVEF >=50%.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
  • other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
  • clinically significant cardiovascular disease;
  • chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391092

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, 1417
Cordoba, Argentina, 5004
La Plata, Argentina, B1902CMK
Mendoza, Argentina, 5500
Salta, Argentina, 4400
San Martin, Argentina, 1650
Santa Fe, Argentina, 2000
Santa Fe, Argentina, 03000
Australia
Auchenflower, Australia, 4066
Fitzroy, Australia, 3065
Geelong, Australia, 3220
Lismore, Australia, 2480
Nambour, Australia, 4560
Newcastle, Australia, 2298
Perth, Australia, 6000
Port Macquarie, Australia, 2444
Wahroonga, Australia, 2076
Wollongong, Australia, 2500
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Wien, Austria, 1090
Belgium
Hasselt, Belgium, 3500
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78 000
Sarajevo, Bosnia and Herzegovina, 71000
Tuzla, Bosnia and Herzegovina, 75000
Brazil
Barretos, Brazil, 14784-400
Florianopolis, Brazil, 88034-000
Goiania, Brazil, 74605-070
Porto Alegre, Brazil, 90610-000
Sao Paulo, Brazil, 01509-010
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Sudbury, Ontario, Canada, P3E 5J1
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H2W 1S6
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H3T 1E2
Quebec City, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Czech Republic
Praha, Czech Republic, 150 06
France
Avignon, France, 84918
Besancon, France, 25030
Bordeaux, France, 33076
Caen, France, 14076
Clermont-ferrand, France, 63011
Dijon, France, 21079
Lille, France, 59020
Montpellier, France, 34298
Villejuif, France, 94805
Italy
Milano, Italy, 20133
Parma, Italy, 43100
Pavia, Italy, 27100
Udine, Italy, 33100
Mexico
Acapulco, Mexico, 39850
Guadalajara, Mexico, 45100
Merida, Mexico, 97500
Monterrey, Mexico, 66260
Torreon, Mexico, 27000
Romania
Bucharest, Romania, 022328
Bucharest, Romania, 76251
Cluj-napoca, Romania, 400015
Iasi, Romania, 700106
Russian Federation
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Obninsk, Russian Federation, 249036
Ryazan, Russian Federation, 390011
St Petersburg, Russian Federation, 197758
UFA, Russian Federation, 450054
Spain
Barcelona, Spain, 08003
Cordoba, Spain, 14004
Madrid, Spain, 28046
Sabadell, Spain, 08208
Zaragoza, Spain, 50009
Turkey
Ankara, Turkey, 06230
Izmir, Turkey, 35100
United Kingdom
Denbigh, United Kingdom, LL18 5UJ
Exeter, United Kingdom, EX2 5DW
London, United Kingdom, SE1 7EH
Manchester, United Kingdom, M20 4BX
Nottingham, United Kingdom, NG5 1PB
Preston, United Kingdom, PR2 9HT
Stoke-on-trent, United Kingdom, ST4 7LN
Weston Super Mare, United Kingdom, BS23 4TQ
Uruguay
Montevideo, Uruguay, 11600
Montevideo, Uruguay, 11200
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: NCT00391092     History of Changes
Other Study ID Numbers: BO20231
Study First Received: October 20, 2006
Last Updated: May 7, 2013
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on April 23, 2014