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.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 15, 2006
Last updated: May 4, 2016
Last verified: May 2016
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 advanced 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 will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Condition Intervention Phase
Breast Cancer
Drug: Epothilone D
Drug: 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: 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: May 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00337649

Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Madrid, Spain, 28041
Valencia, Spain, 46009
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00337649     History of Changes
Other Study ID Numbers: NO17328 
Study First Received: June 15, 2006
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 26, 2016