Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02097459
• Other study ID #: PUMCH-BREAST-AI
• Status: Recruiting
• Phase: Phase 3
• First received: March 19, 2014
• Last updated: May 24, 2016
• Start date: March 2014

Study information

• Verified date: May 2016
• Source: Peking Union Medical College Hospital
• Contact: Qiang Sun, Doctor
• Phone: 8610-69152700
• Email: birds90[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole

• Tamoxifen

• Toremifene

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease Free Survival		3 years	No
Other	Overall Survival		3 years	No
Primary	Disease free survival		10 years	No
Primary	Overall Survival		10 years	No
Secondary	Disease Free Survival		5 years	No
Secondary	Overall Survival		5 years	No