Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
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ClinicalTrials.gov Identifier: NCT00003771 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Menopausal Symptoms | Biological: therapeutic estradiol Drug: norethindrone acetate | Phase 3 |
OBJECTIVES:
- Evaluate the safety of hormone replacement therapy, in terms of risk of recurrence, in women with previously treated, nonrecurrent stage 0-II breast cancer.
- Compare this regimen vs non-hormonal symptomatic treatment, in terms of quality of life and risk of death, in this patient population.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified by center, prior hormone replacement therapy before diagnosis, and concurrent tamoxifen therapy. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive one of the following: Women with an intact uterus whose last menstrual bleeding has occurred within 2 years receive continuous oral cyclic estradiol-norethindrone combination comprising estradiol only on days 1-12, estradiol plus norethindrone on days 13-22, and then estradiol only on days 22-28. Women with an intact uterus whose last menstrual bleeding occurred more than 2 years prior to study receive continuous daily oral estradiol-norethindrone combination. Women who have had a hysterectomy receive continuous daily oral estradiol only.
- Arm II: Patients receive one or more non-hormonal therapies (e.g., clonidine, beta blockers, psychological support, physical exercise, acupuncture).
Treatment in both arms continues for 2 years in the absence of disease progression. Patients may continue their randomized treatment regimen at the discretion of the treating physician.
Quality of life is assessed 3 times during the study and then every two years thereafter. Gynecological health is assessed at 3 months, 6 months, and one year during the study and then annually for at least 5 years. Breast cancer is assessed every 6 months for 3 years and then annually thereafter or at the discretion of the treating physician.
PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study within 5-6 years.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1300 participants |
Allocation: | Randomized |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment |
Study Start Date : | September 1997 |
Actual Study Completion Date : | February 2004 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- History of stage 0-II breast cancer with no more than 4 involved axillary nodes if nodal status and number of nodes investigated is known
- No current evidence of disease
-
Hormone receptor status:
- Positive, negative, or unknown
PATIENT CHARACTERISTICS:
Age:
- Not specified
Sex:
- Female
Menopausal status:
- Menopausal or perimenopausal
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No active liver disease
Renal:
- Not specified
Cardiovascular:
- No prior or concurrent deep vein thrombosis
- No hereditary traits for deep vein thrombosis
- No prior or concurrent cerebral stroke
- No prior or concurrent coronary disease
Other:
- No prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No porphyria
- No other serious disease that would prevent compliance or greatly limit life expectancy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- Prior hormone replacement therapy (HRT) allowed if stopped no more than 4 weeks after breast cancer diagnosis and at least 3 months prior to study
- No prior HRT initiated after breast cancer diagnosis
- No concurrent hormonal therapy for breast cancer except tamoxifen or toremifene
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No prior randomization into trials comparing effects of chemotherapy and bilateral oophorectomy in premenopausal women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003771
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, FIN-00029 | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 | |
Poland | |
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
Warsaw, Poland, 02-781 | |
Sweden | |
Karolinska Hospital | |
Stockholm, Sweden, S-171 76 | |
Uppsala University Hospital | |
Uppsala, Sweden, S-75185 | |
Switzerland | |
Breast Center | |
Zurich, Switzerland, CH-8008 |
Study Chair: | Lars Holmberg, MD, PhD | Uppsala University Hospital | |
Study Chair: | Jonas Bergh, MD, PhD | Karolinska Institutet | |
Study Chair: | C. Rageth, MD, PD | Breast Center | |
Study Chair: | Janusz Jaskiewicz, MD | Maria Sklodowska-Curie National Research Institute of Oncology |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00003771 |
Other Study ID Numbers: |
CDR0000066897 ROC-HABITS EORTC-10992 IBCSG-17-98 SBG-HABITS EU-98077 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 20, 2013 |
Last Verified: | July 2001 |
menopausal symptoms stage I breast cancer stage II breast cancer breast cancer in situ |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estradiol 17 beta-cypionate Estradiol 3-benzoate Norethindrone Norethindrone Acetate Estradiol Polyestradiol phosphate |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptives, Oral Contraceptives, Oral, Synthetic |