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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00337649

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2004

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Response rate (RECIST criteria) [Event driven]

Secondary Outcome Measures

Duration of response, time to tumor progression. [Event driven]
AEs, laboratory tests [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Barcelona	Spain	08035
2	Barcelona	Spain	08036
3	Barcelona	Spain	08041
4	Madrid	Spain	28041
5	Valencia	Spain	46009
6	Valencia	Spain	46010

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00337649

Other Study ID Numbers:

NO17328

First Posted:

Jun 16, 2006

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2016