Clinical trial · Interventional
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
NCT02097459CI-TRIAL-00022372unknownPhase 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)
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
| Toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Failed group
- description
- Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
- interventionNames
- Drug: Anastrozole
- Drug: Tamoxifen
- Drug: Toremifene
- type
- EXPERIMENTAL
- label
- Succeeded group
- description
- Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- No chang group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. * Age of at least 45 and at most 55 years. * Performance status (Karnofsky-Index) \>80% * Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures). * No clinical evidence of local recurrence or distant metastases. * Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated. * Patients have taken the SERMs as endocrine therapy for 2-4 years. * Patients who have had amenorrhea for at least half a year. * Life expectancy of at least 10 years, disregarding the diagnosis of cancer. * Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution. * Patients must be available for and compliant to treatment and follow-up. * Patients registered on this trial must be treated and followed up at the participating center. Exclusion Criteria: * Known hypersensitivity reaction to the investigational compounds or incorporated substances. * Hormone receptor-negative breast cancer. * Local recurrence and/or metastasis of breast cancer. * History of hysterectomy. * Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration. * History of osteoporosis and/or fractures due to osteoporosis. * Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) * Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias * Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study. * Concurrent treatment with other experimental drugs or any other anti-cancer therapy. * Males.
References
Publications (0)
Data not yet available
No reference posted for this study.