Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Tamoxifen
- Conditions
- Breast Cancer
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Disease free survival
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Qiang SUN
Chief of Breast Surgery Department, Professor
Peking Union Medical College Hospital
Eligibility Criteria
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.
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.
Arms & Interventions
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Intervention: Tamoxifen
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Intervention: Anastrozole
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Intervention: Toremifene
Succeeded group
Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
Intervention: Anastrozole
No chang group
Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
Intervention: Tamoxifen
No chang group
Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
Intervention: Toremifene
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 10 years
Overall Survival
Time Frame: 10 years
Secondary Outcomes
- Disease Free Survival(5 years)
- Overall Survival(5 years)