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Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

NCT00919399 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2009-06-12

No results posted yet for this study

Summary

This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Exemestane

25mg a day during 4 months

DRUG

tamoxifen

One 20 mg tablet a day started 1 week after the first Aromasine intake

Sponsors & Collaborators

  • PHARMACIA SAS

    collaborator UNKNOWN

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Henri ROCHE · Institut Claudius Regaud

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • France

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 NCT00919399 on ClinicalTrials.gov