Postmenopausal breast cancer
Conditions
Interventions
Exemestane (25 mg Tablet) is internally administered once a day everyday.
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed histologically as having had invasive ductal carcinoma. 2.Patients 60 years or more, at least one of the following features; A.One year have passed since the final menstruation B.Past history of surgical bilateral ovariectomy (including radiotherapy) C.Past history of hysterectomy and the serum levels of FSH, LH, and E2 are postmenopausal levels 3.StageIIA-IIIB 4.ER-positive and HER2-negative defined with immunohistochemical staining 5.PS(WHO):0-1 6.Patients who satisfy the reference levels of blood cell count and biochemical examination at the institutions 7.Benefit is expected to be obtained from the initial systemic treatment 8.A written consent is obtained
Exclusion criteria
Exclusion criteria: 1.Patients under chemotherapy and hormone therapy (for tumors) 2.Patients under treatment with the drugs (including HRT) that may influence on the conditions of sex hormone 3.Patients with a past history of breast cancer or with double cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Maximum efficacy period 2.Rate of tumor reduction 3.Relationship between pathological response rate and capacity of cell proliferation, activity of aromatase and functional analysis of estrogen receptor of breast cancer cells 4.Time To Treatment Failure 5.Adverse events 6.Changes in bone mineral density | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office(c/o: Shin-toshin Ladies' Clinic)
Outcome results
None listed