A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

NCT ID: NCT00885755

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-13
• Study Completion Date: 2013-02-18

Brief Summary

This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Standard taxane therapy

Intervention Type: DRUG

As prescribed

capecitabine [Xeloda]

Intervention Type: DRUG

1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)

trastuzumab [Herceptin]

Intervention Type: DRUG

8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle

Interventions

Standard taxane therapy

As prescribed

Intervention Type: DRUG

capecitabine [Xeloda]

1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)

Intervention Type: DRUG

trastuzumab [Herceptin]

8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• female patients, >=18 years of age;
• HER2-positive breast cancer;
• al least one metastatic site amenable for core biopsy;
• left ventricular ejection fraction >50%.

Exclusion Criteria

• prior adjuvant/neoadjuvant Herceptin within past 6 months;
• prior adjuvant taxane therapy within past 12 months;
• use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
• known bleeding diatheses.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Royal Prince Alfred Hospital; Medical Oncology

Camperdown, New South Wales, Australia

Royal North Shore Hospital; Oncology

St Leonards, New South Wales, Australia

Eastern Health Breast Cancer Research

East Ringwood, Victoria, Australia

Border Medical Oncology; Murray Valley Private Hospital

Wodonga, Victoria, Australia

Mount Medical Center

Perth, Western Australia, Australia

Royal Perth Hospital; Department of Medical Oncology

Perth, Western Australia, Australia

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Karolinska Hospital; Oncology - Radiumhemmet

Stockholm, , Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, , Sweden

Hull Royal Infirmary

Hull, , United Kingdom

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

Nottingham City Hospital; Oncology

Nottingham, , United Kingdom

Countries

Australia; Spain; Sweden; United Kingdom

Other Identifiers

2008-004013-94

Identifier Type: -

Identifier Source: secondary_id

MO22004

Identifier Type: -

Identifier Source: org_study_id