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

Danish Breast Cancer Cooperative Group (DBCG)

Status and phase: Terminated; Phase 3

Conditions: Operable Breast Neoplasms

Treatments: Drug: letrozole (Femara)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00908531

DBCG 07-REAL

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Postoperative letrozole

Active Comparator group

Description:

Definitive surgery without preoperative AI treatment

Treatment:

Drug: letrozole (Femara)

Preoperative letrozole

Experimental group

Description:

Treatment with letrozole for 4 months before definitive surgery.

Treatment:

Drug: letrozole (Femara)