A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

NCT00559754 | Completed Phase 2 Results

• 1 other identifier: ML20382
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 6

Brief Summary

This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). 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 With Pathological Complete Response (pCR)

  The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.

  After Week 24 (surgery)

Secondary Outcomes (20)

• Percentage of Participants With Objective Clinical Response

  Within 28 days of enrollment, Weeks 12 and 24

• Percentage of Participants With Breast-Conserving Surgery

  Week 24

• Percentage of Participants With pCR by Proliferation of Ki67

  After Week 24 (surgery)

• Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification

  After Week 24 (surgery)

• Percentage of Participants With pCR by KISS1 Protein Expression

  After Week 24 (surgery)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: Docetaxel; Drug: Standard chemotherapy

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

Standard chemotherapy DRUG

As prescribed

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;
• primary HER2-negative operable breast cancer;
• tumor \>2cm in size;
• ECOG performance status 0-1.

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Sabadell, Barcelona, Barcelona, 08208, Spain

Location

Unknown Facility

Córdoba, Cordoba, 14004, Spain

Location

Unknown Facility

Jaén, Jaen, 23007, Spain

Location

Unknown Facility

Lleida, Lerida, 25198, Spain

Location

Unknown Facility

Málaga, Malaga, 29010, Spain

Location

Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Docetaxel

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

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 10, 2014
• Results First Posted: November 10, 2014

Record last verified: 2014-11

Locations

ES (6)