Breast cancer
Conditions
Interventions
None listed
Sponsors
NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria (1)Female patients whose primary lesion is histologically diagnosed as invasive ductal breast cancer (incision biopsy, needle biopsy or mammotome biopsy is conducted); (2)Stage IIA-IIIA;(3)Postmenopausal - Patients that fulfill one of the following criteria: (a) amenorrheic for 1 year or more, (b) menopause caused by bilateral oophorectomy or radiation, (c) FSH is 30mIU/ml or more and E2 is less than 10pg/ml, (d) 60 years or older;(4)Patients without any prior treatment;(5)ER positive and HER2 negative - (a) ER positive: 10% or more of the breast cancer cells are positive, (b) HER2 negative: 0 or 1+ on the Hercep test or, if a 2+, must be less than 1.8 times on FISH (or DISH), (c) immunohistochemical staining on primary lesion fulfills all the criteria above;(6)The following patients whose type of surgery is likely to improve with use of preoperative treatment; (a) patients who are eligible for partial mastectomy but are considered to have problems with risks of positive margins or cosmetics, (b) patients considered eligible for total mastectomy;(7)Patients whose Performance Status (PS) on ECOG is 0-1;(8)Patients whose major organ functions as follows are maintained; (a) white blood cell count is 3,000/mm3 or more or neutrophil count is 1,500/mm3 or more, (b) hemoglobin is 9.0g/dL or more, (c) platelet count is 100,000/mm3 or more, (d) AST/ALT is within 2.5 times the facility's upper limit of the normal, (e) total bilirubin is 1.5g/dL or less (f) normal electrocardiogram (patients without cardiac diseases or severe arrhythmia); (9)Patients who have given written consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKai Toshihiro
NPO Saitama Breast Cancer Clinical Study Group (SBCCSG) Shintoshin Ladies' Mammo Clinic
Outcome results
None listed