Clinical trial · Interventional
Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
NCT00026286CI-TRIAL-00067187completedPhase 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 may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
Conditions
Conditions (3)
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 |
| Hot Flashes | — | UNRESOLVED | — |
| Menopausal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conjugated estrogens | Drug | — | UNRESOLVED |
| medroxyprogesterone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast * No contralateral breast cancer * No recurrent or metastatic disease * Completion of active non-hormonal therapy for breast cancer * Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study * Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR * Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency * If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year * No active endometriosis * No unexplained vaginal bleeding * Hormone receptor status: * Estrogen and progesterone receptor status known for patients with invasive breast cancer PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Postmenopausal * No menstrual period for more than 12 months OR prior bilateral oophorectomy * Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No prior superficial or deep venous or arterial thrombosis * No serious venous stasis disease Pulmonary: * No pulmonary embolus Other: * Must be able to read and speak English * No lower extremity trauma, swelling, or tenderness within the past 4 weeks * No active gallbladder disease * No migraine headaches * No other prior malignancy unless curatively treated with no evidence of recurrence * No concurrent seizure disorder requiring anti-seizure medication PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics * No other concurrent estrogen or hormone replacement therapy * No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes * No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only Radiotherapy: * Not specified Surgery: * At least 4 weeks since prior surgery Other: * At least 12 months since prior treatment for congestive heart failure * Concurrent selective serotonin reuptake inhibitors (SSRI) or antidepressants with SSRI activity allowed if begun at least 3 months prior to study and continue during study
References
Publications (0)
Data not yet available
No reference posted for this study.