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Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

NCT00738777 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-01-22

No results posted yet for this study

Summary

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

Conditions

Interventions

DRUG

Anastrozole

1 mg,QD,PO

DRUG

Anastrozole+Fulvestrant

Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter

DRUG

Tamoxifen

loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

DRUG

Tamoxifen

loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Sabine C Linn, MD · NKI-AvL

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2022-06-30
Completion
2024-06-30

Countries

  • Netherlands

Study Locations

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Entities

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 NCT00738777 on ClinicalTrials.gov