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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337649
• Other study ID #: NO17328
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2004
• Est. completion date: July 2007

Study information

• Verified date: April 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Epothilone D
=100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
• Herceptin
4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Number of Participants with a Dose-Limiting Toxicity		From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Primary	Phase II: Objective Response Rate (per RECIST criteria)		From first dose of study treatment until documented response (up to 3 years, 2 months)
Secondary	Phase II: Duration of Response		From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Secondary	Phase II: Time to Tumor Progression		From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Secondary	Phase I: Plasma Concentration of Epothilone D at Specified Timepoints		Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
Secondary	Number of Participants with at Least One Adverse Event		From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)