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.
Phase 3
60 Years
N/A
60 Years
N/A
Open (Enrolling)
Female
Operable Breast Neoplasms
Female
Operable Breast Neoplasms
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Invasive disease-free survival
Outcome Time Frame:
2020
Safety Issue:
No
Principal Investigator
Bent Ejlertsen, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
DBCG
Authority:
Denmark: Danish Medicines Agency
Study ID:
DBCG 07-REAL
NCT ID:
NCT00908531
Start Date:
May 2009
Completion Date:
June 2024
Related Keywords:
- Operable Breast Neoplasms
- Breast neoplasms
- Randomised trial
- Aromatase Inhibitors
- Preoperative care
- Age 60 or older
- Hormone receptor positive tumor
- Tumor lager than 2 cm
- No distant metastasis
- Breast Neoplasms
- Neoplasms
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