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

NCT00391092 | Completed Phase 3 Results

• 1 other identifier: BO20231
• Study Type: interventional
• Target: 424
• Locations: 15 countries
• Sites: 85

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.

  Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

Secondary Outcomes (6)

• Overall Survival (OS)

  Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

• Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline

  Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

• Duration of Response (DR)

  Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

• Time to Treatment Failure (TTF)

  Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

• Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores

  Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])

Study Arms (2)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: Docetaxel; Drug: Herceptin

2

ACTIVE COMPARATOR

Drug: Docetaxel; Drug: Herceptin

Interventions

bevacizumab [Avastin] DRUG

15mg/kg iv every 3 weeks

1

Docetaxel DRUG

100mg/m2 iv every 3 weeks

1; 2

Herceptin DRUG

8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (89)

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Buenos Aires, 1417, Argentina

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Córdoba, 5004, Argentina

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La Plata, B1902CMK, Argentina

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Mar del Plata, 7600, Argentina

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Mendoza, 5500, Argentina

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Salta, 4400, Argentina

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San Martín, 1650, Argentina

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Santa Fe, 03000, Argentina

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Santa Fe, 2000, Argentina

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Lismore, New South Wales, 2480, Australia

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Newcastle, New South Wales, 2298, Australia

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Port Macquarie, New South Wales, 2444, Australia

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Wahroonga, New South Wales, 2076, Australia

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Wollongong, New South Wales, 2500, Australia

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Auchenflower, Queensland, 4066, Australia

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Nambour, Queensland, 4560, Australia

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Fitzroy, Victoria, 3065, Australia

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Geelong, Victoria, 3220, Australia

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Perth, Western Australia, 6000, Australia

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Graz, 8036, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Vöcklabruck, 4840, Austria

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Banja Luka, 78000, Bosnia and Herzegovina

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Sarajevo, 71000, Bosnia and Herzegovina

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Tuzla, 75000, Bosnia and Herzegovina

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Goiânia, Goiás, 74605-070, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Florianópolis, Santa Catarina, 88034-000, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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São Paulo, São Paulo, 01509-010, Brazil

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Calgary, Alberta, T2N 4N2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Greater Sudbury, Ontario, P3E 5J1, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H2W 1S6, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1S 4L8, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Prague, 128 08, Czechia

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Prague, 150 06, Czechia

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Avignon, 84918, France

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Besançon, 25030, France

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Bordeaux, 33076, France

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Caen, 14076, France

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Clermont-Ferrand, 63011, France

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Dijon, 21079, France

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Lille, 59020, France

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Montpellier, 34298, France

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Villejuif, 94805, France

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Parma, Emilia-Romagna, 43100, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Milan, Lombardy, 20133, Italy

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Pavia, Lombardy, 27100, Italy

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Acapulco, 39850, Mexico

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Guadalajara, 45100, Mexico

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Mérida, 97500, Mexico

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Monterrey, 66260, Mexico

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Torreón, 27000, Mexico

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Bucharest, 022328, Romania

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Bucharest, 050098, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 700106, Romania

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Kazan', 420029, Russia

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Moscow, 115478, Russia

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Obninsk, 249036, Russia

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Ryazan, 390011, Russia

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Saint Petersburg, 197758, Russia

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Ufa, 450054, Russia

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Barcelona, Barcelona, 08003, Spain

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Sabadell, Barcelona, Barcelona, 08208, Spain

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Córdoba, Cordoba, 14004, Spain

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Madrid, Madrid, 28046, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Izmir, 35100, Turkey (Türkiye)

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Sıhhiye, Ankara, 06100, Turkey (Türkiye)

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Exeter, EX2 5DW, United Kingdom

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London, SE1 7EH, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Preston, PR2 9HT, United Kingdom

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Rhyl, LL18 5UJ, United Kingdom

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Stoke-on-Trent, ST4 6QG, United Kingdom

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Weston-super-Mare, BS23 4TQ, United Kingdom

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Montevideo, 11200, Uruguay

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Montevideo, 11600, Uruguay

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Related Publications (1)

• Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.

  PMID: 23569311 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Docetaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 28, 2015
• Results First Posted: August 14, 2015

Record last verified: 2015-08

Locations

AR (9); RO (4); CZ (2); AU (10); RU (6); ES (5); TU (2); CA (11); FR (9); BO (3); UR (2); ME (5); BR (5); GB (8); IT (4)