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A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00337649
First received: June 15, 2006
Last updated: November 3, 2014
Last verified: November 2014

June 15, 2006
November 3, 2014
May 2004
April 2008   (final data collection date for primary outcome measure)
Response rate (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Response rate (using RECIST criteria)
Complete list of historical versions of study NCT00337649 on ClinicalTrials.gov Archive Site
  • Duration of response, time to tumor progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory tests [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Duration of response (for patients with complete or partial response); time to tumor progression. Safety: Adverse events; laboratory tests.
Not Provided
Not Provided
 
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer.
An Open -Label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer.

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanc ed or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin wi ll be administered intravenously on a weekly schedule; a 4mg/kg loading dose wil l be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on st udy treatment is until disease progression, and the target sample size is <100 i ndividuals.

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: Epothilone D
    <100mg/m2 iv on days 1, 8 and 15 every 4 weeks
  • Drug: Herceptin
    4mg/kg iv loading dose followed by 2mg/kg iv weekly
Experimental: 1
Interventions:
  • Drug: Epothilone D
  • Drug: Herceptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women >=18 years;
  • locally advanced or metastatic breast cancer;
  • HER-2 overexpression (FISH + or IHC 3+);
  • >=1 measurable lesion;
  • up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Exclusion Criteria:

  • pre-existing neuropathy >=grade 2;
  • known CNS metastases;
  • congestive heart failure, or myocardial infarction within the last 6 months;
  • previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00337649
NO17328
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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