Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: March 16, 2009
Last updated: January 12, 2015
Last verified: January 2015

March 16, 2009
January 12, 2015
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 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 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.

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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Australia,   Spain,   Sweden,   United Kingdom
MO22004, 2008-004013-94
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2015

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