NCT00337649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started May 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

June 15, 2006

Last Update Submit

April 27, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Phase II: Objective Response Rate (per RECIST criteria)

    From first dose of study treatment until documented response (up to 3 years, 2 months)

Secondary Outcomes (4)

  • Phase II: Duration of Response

    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

    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

    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

    From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)

Study Arms (2)

Phase I - Epothilone D Dose Escalation

EXPERIMENTAL
Drug: Epothilone DDrug: Herceptin

Phase II - Epothilone D Maximum Tolerated Dose

EXPERIMENTAL
Drug: Epothilone DDrug: Herceptin

Interventions

Epothilone DDRUG

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

Also known as: RO4598715, KOS-862
Phase I - Epothilone D Dose EscalationPhase II - Epothilone D Maximum Tolerated Dose
HerceptinDRUG

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

Also known as: Trastuzumab
Phase I - Epothilone D Dose EscalationPhase II - Epothilone D Maximum Tolerated Dose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08041, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

desoxyepothilone BTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

May 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

ES(6)