Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)
Phase 2
Recruiting
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000006453
- Lead Sponsor
- PO Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria (1)Patients already receiving breast cancer treatment either with chemotherapy or endocrine therapy; (2)Patients who have a history of breast cancer. However, a patient can be considered eligible if the patient has metachronous bilateral breast cancer and it has been 10 years or more since the patient underwent surgery for contralateral breast cancer; (3)Patients who have active multiple primary cancer; (4)Patients who should receive surgery, chemotherapy or molecular targeted therapy instead of endocrine therapy as first line treatment; (5)Besides the above, patients that are considered ineligible by the principal investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prior to administering preoperative Exemestane, assess the possibility of administering postoperative chemotherapy and whether this possibility of administering chemotherapy changes after treatment {Examine whether chemotherapy will be administered and whether it really is administered (determined by primary physician) based on the eligibility criteria}
- Secondary Outcome Measures
Name Time Method (1) Response rate, tumor size (palpation and diagnostic imaging), type of surgery, rate of positive resection margins in breast-conserving surgery, PEPI score {lymph node metastasis, pathological tumor size, ER, Ki67}, pathological therapeutic efficacy, PgR, HER2, other biomarkers, disease-free survival rate, recurrence-free survival rate, overall survival rate, safety