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: June 23, 2014
Last verified: June 2014
  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 loca lly recurrent or metastatic breast cancer who have not received prior chemothera py for their metastatic disease. Patients will be randomized 1:1 to receive eith er Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg i v q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxe l alone. The anticipated time on study treatment is until disease progression, a nd 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: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mar del Plata, Argentina, 7600
Mendoza, Argentina, 5500
Salta, Argentina, 4400
San Martin, Argentina, 1650
Santa Fe, Argentina, 2000
Santa Fe, Argentina, 03000
Australia, New South Wales
Lismore, New South Wales, Australia, 2480
Newcastle, New South Wales, Australia, 2298
Port Macquarie, New South Wales, Australia, 2444
Wahroonga, New South Wales, Australia, 2076
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Nambour, Queensland, Australia, 4560
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Vöcklabruck, Austria, 4840
Wien, Austria, 1090
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Tuzla, Bosnia and Herzegovina, 75000
Brazil
Goiania, GO, Brazil, 74605-070
Porto Alegre, RS, Brazil, 90610-000
Florianopolis, SC, Brazil, 88034-000
Barretos, SP, Brazil, 14784-400
Sao Paulo, SP, 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, H3A 1A1
Montreal, Quebec, Canada, H2W 1S6
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Quebec, Canada, G1S 4L8
Czech Republic
Praha 2, Czech Republic, 128 08
Praha 5, 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
Parma, Emilia-Romagna, Italy, 43100
Udine, Friuli-Venezia Giulia, Italy, 33100
Milano, Lombardia, Italy, 20133
Pavia, Lombardia, Italy, 27100
Mexico
Acapulco, Mexico, 39850
Guadalajara, Mexico, 45100
Merida, Mexico, 97500
Monterrey, Mexico, 66260
Torreon, Mexico, 27000
Romania
Bucharest, Romania, 050098
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
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
Saint-Petersburg, Russian Federation, 197758
UFA, Russian Federation, 450054
Spain
Sabadell, Barcelona, Barcelona, Spain, 08208
Barcelona, Spain, 08003
Cordoba, Spain, 14004
Madrid, Spain, 28046
Zaragoza, Spain, 50009
Turkey
Izmir, Turkey, 35100
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
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
Rhyl, United Kingdom, LL18 5UJ
Stoke-on-Trent, United Kingdom, ST4 6QG
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: June 23, 2014
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014