Clinical trial · Interventional
Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment
NCT00003771CI-TRIAL-00012214completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Menopausal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| norethindrone acetate | Drug | — | UNRESOLVED |
| therapeutic estradiol | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBrincat M, Muscat Baron Y, Ciantar E. Hormone replacement in women with breast cancer: the HABITS study. Endocrine. 2004 Aug;24(3):255-7. doi: 10.1385/endo:24:3:255. PMID 15542894
- RESULTHolmberg L, Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpaa J; HABITS Study Group. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25. PMID 18364505
- RESULTHolmberg L, Anderson H; HABITS steering and data monitoring committees. HABITS (hormonal replacement therapy after breast cancer--is it safe?), a randomised comparison: trial stopped. Lancet. 2004 Feb 7;363(9407):453-5. doi: 10.1016/S0140-6736(04)15493-7. PMID 14962527