ER positive, HER2 negative, Stage II or IIIA [T2-3,N0-2,M0], Primary Postmenopausal Invasive Breast Cancer Patients
Conditions
Sponsors
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Invasive breast cancer confirmed by biopsy (excluding lobular carcinoma and mucinous adenocarcinoma) 2) T2-T3, N0-2, M0 (In case of multiple ipsilateral breast cancer, all lesions should be histopathologically diagnosed) 3) ER positive on immunohistological staining (positive stained cells over1%) 4) HER2 negative (IHC: 1+ or 0, or FISH: HER2/CEP17 <1.8 [or mean copy number of HER2 gene <4 for each nucleus]) 5) Ki67 index less than 30% 6) No previous treatments 7) ECOG Performance Status (P.S.): 0 - 1 8) Any of the followings in which the surgical procedure is expected to result in improvement by the preoperative treatment [1]Although partial mastectomy is indicated, the risk of positive margins or any cosmetic matters are involved. [2]Total mastectomy is indicated. 9) Either the presence or absence of axillary lymph node metastasis is acceptable. 10) Cases with any of the following postmenopausal criteria is met [1]Amenorrhea for at least one year [2]Menopause due to bilateral ovariectomy or radiation [3]FSH over 30mIU/mL and E2 <10 pg/mL (11) Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved. [1]White blood cell count >=3,000/mm3 or Neutrophil count >=1,500/mm3 [2]Platelet count >=100,000/mm3 [3]Hemoglobin >=9.0 g/dL [4]AST, ALT <=2.5 x Upper limit of facility reference [5]Total bilirubin <=1.5 x Upper limit of facility reference [6]Serum creatinine <=1.5 x Upper limit of facility reference 12) Physician judges an indication for preoperative hormone therapy, taking other treatments such as surgery, preoperative chemotherapy, and preoperative hormone therapy into consideration. 13) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Prior treatment for the breast cancer by chemotherapy or hormone therapy (2) Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.) (eligible if the last dose was at least two months before) (3) Past history of breast cancer or presence of active multiple cancers (eligible if DCIS is located on the other side) (4) Bilateral breast cancer (if tumors on both sides meet the eligibility criteria, the case is not excluded.) (5) Cases for whom non-hormonal therapies such as surgical therapy, chemotherapy, or antibody therapy are recommended as the first treatment of choice (6) Past history of hypersensitivity to any drug or contrast agent used in this study (7) Cases in which another study drug is given for a disease other than breast cancer (8) Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms (9) Cases considered ineligible by the attending physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response at Week 24 and Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Histological response rate. (2) Survival and relapse-free survival: To examine the tumor regression effect between Week 8 and 12, and at Week 24 and 36 and the correlation with Ki67 index values before and after the treatment. (3) Clinical benefit: Breast-conserving surgery rate, axillary lymph node metastasis positive rate (reduction rate from the baseline status), local relapse rate. (4) To explore clinicopathologic and molecular biological markers related to the tumor regression effect and long-term prognostic prediction. (5) Development of adverse events: To verify the safety. | — |
Countries
Japan
Contacts
Public ContactJun Fukase
Japan Breast Cancer Research Group (JBCRG) Head Office
Outcome results
None listed