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Completed

NCT Number: NCT00337649

A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epothilone D

Drug

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

Other names: RO4598715, KOS-862

Herceptin

Drug

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

Other names: Trastuzumab

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 16, 2006
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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