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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00885755
First received: March 16, 2009
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This single arm study will evaluate alterations in molecular marker expression i n HER2-positive targeted therapy, and will evaluate the effect of continued trea tment with Herceptin and Xeloda beyond progression following initial Herceptin-t axane chemotherapy. Patients who develop progressive disease will receive first- line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane the rapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid o n days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for bio marker 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.


Condition Intervention Phase
Breast Cancer
Drug: Standard taxane therapy
Drug: capecitabine [Xeloda]
Drug: trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response to Herceptin/Xeloda (in patients who progress) [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]
  • Adverse events, serious adverse events [ Time Frame: Throughout study--monitored at each clinic visit ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Standard taxane therapy
As prescribed
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885755

Locations
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
St. Leonards, New South Wales, Australia, 2065
Australia, Victoria
East Ringwood, Victoria, Australia, 3135
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Spain
Santander, Cantabria, Spain, 39008
Valencia, Spain, 46010
Sweden
Stockholm, Sweden, 17176
Uppsala, Sweden, 75185
United Kingdom
Hull, United Kingdom, HU3 2JZ
Manchester, United Kingdom, M20 4BX
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00885755     History of Changes
Other Study ID Numbers: MO22004, 2008-004013-94
Study First Received: March 16, 2009
Last Updated: September 22, 2014
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014