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: July 14, 2014
Last verified: July 2014

March 16, 2009
July 14, 2014
August 2009
April 2013   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885755 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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)
Experimental: 1
Interventions:
  • Drug: trastuzumab [Herceptin]
  • Drug: Standard taxane therapy
  • Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Spain,   Sweden,   United Kingdom
 
NCT00885755
MO22004, 2008-004013-94
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP