A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

NCT00929240 | Completed Phase 3 Results

• 2 other identifiers: MO222232008-006872-31
• Study Type: interventional
• Target: 287
• Locations: 11 countries
• Sites: 63

Brief Summary

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)

  Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

• Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)

  PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

Secondary Outcomes (10)

• Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

• Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

• Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

• Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)

  Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years

• Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)

  Years 1 and 2

Study Arms (2)

Avastin (bevacizumab)

ACTIVE COMPARATOR

Drug: bevacizumab [Avastin]

Avastin (bevacizumab) + Xeloda (capecitabine)

EXPERIMENTAL

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

Interventions

bevacizumab [Avastin] DRUG

15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)

Avastin (bevacizumab); Avastin (bevacizumab) + Xeloda (capecitabine)

capecitabine [Xeloda] DRUG

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

Avastin (bevacizumab) + Xeloda (capecitabine)

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• HER2-negative metastatic breast cancer
• candidates for taxane-based chemotherapy;
• ECOG performance status of 0 or 1.

You may not qualify if:

• previous chemotherapy for metastatic breast cancer;
• prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
• prior radiotherapy for treatment of metastatic disease;
• chronic daily treatment with aspirin (325 mg/day) or clopidogrel(\>75mg/day).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (63)

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Fortaleza, Ceará, 60336-550, Brazil

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Belo Horizonte, Minas Gerais, 30190-130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

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Ijuí, Rio Grande do Sul, 98700-000, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Jaú, São Paulo, 17210-080, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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São Paulo, São Paulo, 08270-070, Brazil

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Beijing, 100021, China

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Beijing, 100071, China

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Beijing, 100853, China

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Hangzhou, 310009, China

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Hangzhou, 310022, China

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Shanghai, 200032, China

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Alexandria, 11737, Egypt

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Cairo, 11796, Egypt

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Amiens, 80090, France

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Angers, 49933, France

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Besançon, 25030, France

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Bobigny, 93009, France

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Dijon, 21079, France

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Hyères, 83400, France

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Le Coudray, 28630, France

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Lille, 59000, France

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Paris, 75231, France

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Paris, 75970, France

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Périgueux, 24000, France

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Rodez, 12027, France

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Saint-Priest-en-Jarez, 42271, France

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Strasbourg, 67010, France

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Hong Kong, 852, Hong Kong

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Hong Kong, Hong Kong

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Bangalore, 560027, India

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Hyderabad, 500034, India

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Mumbai, 400012, India

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Mumbai, 400020, India

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New Delhi, 110 060, India

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New Delhi, 110085, India

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Brindisi, Apulia, 72100, Italy

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Napoli, Campania, 80131, Italy

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Trieste, Friuli Venezia Giulia, 34100, Italy

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Genoa, Liguria, 16132, Italy

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Saronno, Lombardy, 21047, Italy

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Antella (FI), Tuscany, 50011, Italy

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Bydgoszcz, 85-796, Poland

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Wroclaw, 53-413, Poland

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Dammam, 31444, Saudi Arabia

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Jeddah, 21497, Saudi Arabia

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Jeddah, 21589, Saudi Arabia

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Alcoy, Alicante, 03804, Spain

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Sabadell, Barcelona, Barcelona, 08208, Spain

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Alcazar de S. Juan, Ciudad Real, 13600, Spain

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Jaén, Jaen, 23007, Spain

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Málaga, Malaga, 29010, Spain

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Toledo, Toledo, 45004, Spain

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Valencia, Valencia, 46026, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Ankara, 06500, Turkey (Türkiye)

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Ankara, 06800, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Istanbul, 34000, Turkey (Türkiye)

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Sıhhiye, Ankara, 06100, Turkey (Türkiye)

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Related Publications (1)

• Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.

  PMID: 25273343 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Capecitabine

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

1-800-821-8590

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: June 16, 2009
• First Posted: June 26, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 3, 2015
• Results First Posted: March 3, 2015

Record last verified: 2015-03

Locations

BR (9); HK (2); SA (3); IT (6); EG (2); FR (14); CN (6); PL (2); ES (8); TU (5); IN (6)