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

NCT ID: NCT00337649

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I - Epothilone D Dose Escalation

Group Type: EXPERIMENTAL

Epothilone D

Intervention Type: DRUG

≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks

Herceptin

Intervention Type: DRUG

4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Phase II - Epothilone D Maximum Tolerated Dose

Group Type: EXPERIMENTAL

Epothilone D

Intervention Type: DRUG

≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks

Herceptin

Intervention Type: DRUG

4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Interventions

Epothilone D

≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks

Intervention Type: DRUG

Herceptin

4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Intervention Type: DRUG

Other Intervention Names

RO4598715; KOS-862; Trastuzumab

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Valencia, , Spain

Countries

Spain

Other Identifiers

NO17328

Identifier Type: -

Identifier Source: org_study_id