Clinical trial NCT02097459: Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
Official title: Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
Endocrine therapy
Perimenopausal and recently postmenopausal patients
Early-stage hormone receptor-positive
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 600
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Disease free survival
timeFrame: 10 years
measure: Overall Survival
timeFrame: 10 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
measure: Disease Free Survival
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiang Sun, Doctor
role: STUDY_CHAIR
References: