Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Toremifene; Drug: Tamoxifen

• Registration Number: NCT02097459
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-27
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25
• Primary Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Failed group	Anastrozole	Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
No chang group	Toremifene	Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
Failed group	Tamoxifen	Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Failed group	Toremifene	Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Succeeded group	Anastrozole	Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
No chang group	Tamoxifen	Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.

Primary Outcome Measures

Name	Time	Method
Disease free survival	10 years
Overall Survival	10 years

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	5 years
Overall Survival	5 years

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China