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

April 27, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Madrid, Spain, 28041
      • Valencia, Spain, 46010
      • Valencia, Spain, 46009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I - Epothilone D Dose Escalation
Drug: Epothilone D
≤100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
Other Names:
  • RO4598715
  • KOS-862
Drug: Herceptin
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Other Names:
  • Trastuzumab
Experimental: Phase II - Epothilone D Maximum Tolerated Dose
Drug: Epothilone D
≤100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
Other Names:
  • RO4598715
  • KOS-862
Drug: Herceptin
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Other Names:
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: Number of Participants with a Dose-Limiting Toxicity
Time Frame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
Time Frame: From first dose of study treatment until documented response (up to 3 years, 2 months)
From first dose of study treatment until documented response (up to 3 years, 2 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase II: Duration of Response
Time Frame: From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase II: Time to Tumor Progression
Time Frame: From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase I: Plasma Concentration of Epothilone D at Specified Timepoints
Time Frame: Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
Number of Participants with at Least One Adverse Event
Time Frame: From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)
From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO17328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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