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

Phase 3

Terminated

• Conditions: Operable Breast Neoplasms
• Interventions: Drug: letrozole (Femara)

• Registration Number: NCT00908531
• Lead Sponsor: Danish Breast Cancer Cooperative Group

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 postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2013-12-01
• Study Completion: 2013-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative letrozole	letrozole (Femara)	Definitive surgery without preoperative AI treatment
Preoperative letrozole	letrozole (Femara)	Treatment with letrozole for 4 months before definitive surgery.

Primary Outcome Measures

Name	Time	Method
pCR	At four months	Complete response rate
Clinical tumor response	At four months	Ultrasound

Secondary Outcome Measures

Name	Time	Method
Overall survival	At ten years	Death of any cause

Trial Locations

Locations (9)

Dept. of Oncology; Odense University Hospital; 🇩🇰 Odense, Denmark

Depart. of Breast Surgery, Ringsted Sygehus; 🇩🇰 Ringsted, Denmark

Dept. of Breast Surgery; Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark

Dept. of Surgery; Århus Sygehus; 🇩🇰 Århus, Denmark

Dept. of Breast Surgery; Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dept. of Breast Surgery; Aalborg Sygehus; 🇩🇰 Aalborg, Denmark

Dept. of Surgery; Sydvestjysk Sygehus Esbjerg; 🇩🇰 Esbjerg, Denmark

Dept. of Breast Surgery; Vejle Sygehus; 🇩🇰 Vejle, Denmark

Dept. of Breast Surgery; Herlev Hospital; 🇩🇰 Herlev, Denmark