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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00337649

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ixabepilone Trastuzumab Desoxyepothilone B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

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 Completion Date:	April 2008

Arms	Assigned Interventions
1: Experimental	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

VALENCIA, Spain, 46009

BARCELONA, Spain, 08035

VALENCIA, Spain, 46010

Barcelona, Spain, 08036

MADRID, Spain, 28041

BARCELONA, Spain, 08025

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO17328
Study First Received:	June 15, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00337649
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Epothilones
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009