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A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

NCT02015676 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2015-03-12

Study results available
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Summary

This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.

Conditions

Interventions

DRUG

trastuzumab

Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression

DRUG

paclitaxel

60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression

DRUG

Myocet

40 mg/m\^2 IV weekly; dose increased to 50 mg/m\^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015676 on ClinicalTrials.gov