Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Anastrozole
* Drug: Tamoxifen
* Drug: Toremifene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Failed group<br>Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy. | Drug: Anastrozole<br> <br> * Other names: Arimidex;Drug: Tamoxifen<br> <br> Drug: Toremifene<br> <br> * Other names: Shu Rui;|
| Experimental: Succeeded group<br>Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy. | Drug: Anastrozole<br> <br> * Other names: Arimidex;|
| Active Comparator: No chang group<br>Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy. | Drug: Tamoxifen<br> <br> Drug: Toremifene<br> <br> * Other names: Shu Rui;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 10 years | 
| Overall Survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival |  | 5 years | 
| Overall Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocrine therapy, Perimenopausal and recently postmenopausal patients, Early-stage hormone receptor-positive, Breast cancer