A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

NCT00576901 | Terminated Phase 2 Results

• 1 other identifier: ML20561
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Pathological Complete Response (pCR)

  pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.

  At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)

Secondary Outcomes (4)

• Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)

  Day 1 of Cycles 1-6

• Progression-Free Survival

  Cycles 1-6

• Overall Survival

  Cycles 1-6

• Percentage of Participants Undergoing Breast-Conserving Surgery

  Following Cycle 6

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

bevacizumab [Avastin] DRUG

15mg/kg iv on day 1 of each 3 week cycle

1

Docetaxel DRUG

75mg/m2 iv on day 1 of each 3 week cycle

1

Xeloda DRUG

2000mg/m2 po on days 1-15 of each 3 week cycle

1

Eligibility Criteria

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

You may qualify if:

• female patients, \>=18 years of age;
• HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
• ECOG performance status 0-1.

You may not qualify if:

• metastatic disease (stage IV);
• previous treatment for breast cancer;
• evidence of CNS metastasis;
• current or recent (within 10 days of first dose of Avastin) use of aspirin (\>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
• clinically significant cardiovascular disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Docetaxel; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

ES (1)