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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337649
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Epothilone D Drug: Herceptin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2004
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response rate (RECIST criteria) [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Duration of response, time to tumor progression. [ Time Frame: Event driven ]
  2. AEs, laboratory tests [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche Identifier: NCT00337649     History of Changes
Other Study ID Numbers: NO17328
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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