Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
NCT00003771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300
Last updated 2013-09-20
Summary
RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer.
PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.
Conditions
- Breast Cancer
- Menopausal Symptoms
Interventions
- BIOLOGICAL
-
therapeutic estradiol
- DRUG
-
norethindrone acetate
Sponsors & Collaborators
-
Scandinavian Breast Group
collaborator OTHER -
ETOP IBCSG Partners Foundation
collaborator NETWORK -
European Organisation for Research and Treatment of Cancer - EORTC
collaborator NETWORK -
Regional Oncologic Center
lead OTHER
Principal Investigators
-
Lars Holmberg, MD, PhD · Uppsala University Hospital
-
Jonas Bergh, MD, PhD · Karolinska Institutet
-
C. Rageth, MD, PD · Breast Center
-
Janusz Jaskiewicz, MD · Maria Sklodowska-Curie National Research Institute of Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1997-09-30
- Completion
- 2004-02-29
Countries
- Finland
- Norway
- Poland
- Sweden
- Switzerland
Study Locations
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