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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: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

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

  Eligibility

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

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

Locations
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Madrid, Spain, 28041
Valencia, Spain, 46010
Valencia, Spain, 46009
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: NCT00337649     History of Changes
Other Study ID Numbers: NO17328
Study First Received: June 15, 2006
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Epothilones
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013