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Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer

NCT00496795 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-29

No results posted yet for this study

Summary

Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer

Protocol summary.

Principal Investigator Hans P. Eikesdal, Professor, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen

Project leader: Professor Per Eystein Lønning, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen

Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon

Participants. Dept of Oncology Stephanie Geisler, Consultant Oncologist Jurgen Geisler, Consultant Oncologist

Type of Study Phase II, Translational research

Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed by docetaxel sequential therapy

Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100 mg/m2 2-weekly x 4.

Patients: Breast cancer patients below 65 years of age suffering from large (\>4 cm largest diameter, non-inflammatory and / or N2-N3) primary breast cancer.

.

Clinical aim: Assessing responsiveness to this dose intensive regimen.

Number of patients to be enrolled: 60 - 100

Conditions

  • Stage III Breast Cancer AJCC V7

Interventions

OTHER

epirubicin/docetaxel sequential

Epirubicin 60 mg/m2, q2w 4 cycles. Followed by docetaxel 100 mg/m2 q2w 4 cycles

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Per E Lonning, MD PhD · Section of Oncology, Institute of Medicine, University of Bergen, Haukeland University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2016-05-31
Completion
2026-05-31

Countries

  • Norway

Study Locations

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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 NCT00496795 on ClinicalTrials.gov