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

NCT00811135 | Completed Phase 2 Results

• 2 other identifiers: MO219262008-003283-20
• Study Type: interventional
• Target: 88
• Locations: 6 countries
• Sites: 35

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)

  Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.

  Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

Secondary Outcomes (8)

• Number of Participants With Disease Progression or Death

  Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

• Progression Free Survival (PFS)

  Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

• Number of Participants With Overall Survival (OS)

  Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

• Overall Survival (OS)

  Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

• Number of Participants With Time to Progression (TTP)

  Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

Interventions

bevacizumab [Avastin] DRUG

15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles

1

capecitabine [Xeloda] DRUG

1000mg/m2 bid po on days 1-14 of each 3-week cycle

1

trastuzumab [Herceptin] DRUG

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

1

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;
• breast cancer with measurable locally recurrent or metastatic lesions;
• candidate for chemotherapy;
• HER2-positive disease;
• ECOG PS of \<=2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (35)

Unknown Facility

Herlev, 2730, Denmark

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Vejle, 7100, Denmark

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Aix-en-Provence, 13616, France

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Béziers, 34500, France

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Créteil, 94010, France

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Dechy, 59187, France

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Lormont, 33310, France

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Marseille, 13285, France

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Narbonne, 11780, France

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Paris, 75475, France

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Paris, 75571, France

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Paris, 75651, France

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Paris, 75970, France

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Rodez, 12027, France

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Saint-Jean, 31240, France

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Saint-Quentin, 02321, France

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Toulouse, 31076, France

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Moscow, 115478, Russia

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Moscow, 143423, Russia

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Saint Petersburg, 197758, Russia

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Bratislava, 833 10, Slovakia

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28040, Spain

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Málaga, Malaga, 29010, Spain

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Pontevedra, Pontevedra, 36002, Spain

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Salamanca, Salamanca, 37007, Spain

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Seville, Sevilla, 41013, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46026, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Eskilstuna, 63188, Sweden

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Sundsvall, 85186, Sweden

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Uppsala, 75185, Sweden

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Unknown Facility

Vaxjo, 35185, Sweden

Location

Related Publications (1)

• Martin M, Makhson A, Gligorov J, Lichinitser M, Lluch A, Semiglazov V, Scotto N, Mitchell L, Tjulandin S. Phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment for HER-2-positive locally recurrent or metastatic breast cancer. Oncologist. 2012;17(4):469-75. doi: 10.1634/theoncologist.2011-0344. Epub 2012 Mar 30.

  PMID: 22467666 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Capecitabine; 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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 29, 2016
• Results First Posted: December 8, 2015

Record last verified: 2016-08

Locations

DK (2); ES (10); RU (3); SL (1); SE (4); FR (15)