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

Operable Breast Neoplasms Clinical Trial

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Official title:

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00908531
• Other study ID #: DBCG 07-REAL
• Status: Terminated
• Phase: Phase 3
• Start date: May 2009
• Est. completion date: December 1, 2013

Study information

• Verified date: April 2019
• Source: Danish Breast Cancer Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: December 1, 2013
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Operable Breast Neoplasms

Intervention

Drug:
• letrozole (Femara)
tablet 2.5 mg daily

Locations

Country	Name	City	State
Denmark	Dept. of Breast Surgery; Aalborg Sygehus	Aalborg
Denmark	Dept. of Surgery; Århus Sygehus	Århus
Denmark	Dept. of Breast Surgery; Rigshospitalet	Copenhagen
Denmark	Dept. of Surgery; Sydvestjysk Sygehus Esbjerg	Esbjerg
Denmark	Dept. of Breast Surgery; Herlev Hospital	Herlev
Denmark	Dept. of Oncology; Odense University Hospital	Odense
Denmark	Depart. of Breast Surgery, Ringsted Sygehus	Ringsted
Denmark	Dept. of Breast Surgery; Vejle Sygehus	Vejle
Denmark	Dept. of Breast Surgery; Regionshospitalet Viborg	Viborg

Sponsors (4)

Lead Sponsor	Collaborator
Danish Breast Cancer Cooperative Group	Danish Cancer Society, Novartis, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Skriver SK, Laenkholm AV, Rasmussen BB, Handler J, Grundtmann B, Tvedskov TF, Christiansen P, Knoop AS, Jensen MB, Ejlertsen B. Neoadjuvant letrozole for postmenopausal estrogen receptor-positive, HER2-negative breast cancer patients, a study from the Danish Breast Cancer Cooperative Group (DBCG). Acta Oncol. 2018 Jan;57(1):31-37. doi: 10.1080/0284186X.2017.1401228. Epub 2017 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Complete response rate	At four months
Primary	Clinical tumor response	Ultrasound	At four months
Secondary	Overall survival	Death of any cause	At ten years