Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02097459

Collaborator

(none)

600

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Anastrozole Drug: Tamoxifen Drug: Toremifene	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Failed group

Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.

Drug: Anastrozole

Other Names:

Arimidex

Drug: Tamoxifen

Drug: Toremifene

Other Names:

Fareston

Shu Rui

Experimental: Succeeded group

Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.

Drug: Anastrozole

Other Names:

Arimidex

Active Comparator: No chang group

Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.

Drug: Tamoxifen

Drug: Toremifene

Other Names:

Fareston

Shu Rui

Outcome Measures

Primary Outcome Measures

Disease free survival [10 years]
Overall Survival [10 years]

Secondary Outcome Measures

Disease Free Survival [5 years]
Overall Survival [5 years]

Other Outcome Measures

Disease Free Survival [3 years]
Overall Survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.