Status:

TERMINATED

Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Lead Sponsor:

Danish Breast Cancer Cooperative Group

Collaborating Sponsors:

The Danish Medical Research Council

Danish Cancer Society

Conditions:

Operable Breast Neoplasms

Eligibility:

FEMALE

60+ years

Phase:

PHASE3

Brief Summary

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in...

Eligibility Criteria

Inclusion

  • Informed consent
  • Age 60 years or older
  • Measurable non-metastatic and non-inflammatory breast cancer
  • Tumor of 2 cm or larger
  • ER and/or PgR positive tumor
  • Co-morbidity index 0 - 3, e.g., no other serious medical condition

Exclusion

  • Prior medical therapy for a malignant disease, including aromatase inhibitors
  • Distant metastasis
  • Need for chemotherapy
  • Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
  • Treatment with a non-approved drug within 30 days

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

123 Patients enrolled

Trial Details

Trial ID

NCT00908531

Start Date

May 1 2009

End Date

December 1 2013

Last Update

April 29 2019

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Dept. of Breast Surgery; Aalborg Sygehus

Aalborg, Denmark, DK-9000

2

Dept. of Surgery; Århus Sygehus

Aarhus, Denmark, DK-8000

3

Dept. of Breast Surgery; Rigshospitalet

Copenhagen, Denmark, DK-2100

4

Dept. of Surgery; Sydvestjysk Sygehus Esbjerg

Esbjerg, Denmark, DK-6700