Breast cancer
Conditions
Interventions
None listed
Sponsors
General Incorporated Association of CSPOR-BC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases that satisfy all of the following conditions are included in this study as subjects. (1) A patient with estrogen receptor positive postmenopausal breast cancer who is histologically diagnosed as breast cancer. (2) Diagnosis of breast cancer corresponds to either of the following. No distinction is made according to the presence or absence of measurable lesions. 1. Stage 4 breast cancer associated with distant metastasis that cannot be a candidate for surgery at the first visit. 2. Breast cancer associated with progression or recurrence caused by distant metastasis after initial treatment for breast cancer aiming at curing. (3) Endocrine therapy for metastatic breast cancer is planned. (4) Performance status of ECOG is 0 or 1. (5) Previous endocrine therapy for breast cancer corresponds to either of the following. No distinction is made according to the type of endocrine therapeutic medicines used. 1. A case that has continuously received endocrine therapeutic medicines as a postoperative adjunct therapy and in which recurrence occurred within 5 years after the initiation of the endocrine therapy. 2. A case that received endocrine therapy as the primary treatment for metastatic breast cancer and in which progression of the disease occurred within 9 months after the initiation of the endocrine therapy. (6) Previous chemotherapy for breast cancer corresponds to either of the following: 1. No previous chemotherapy was administered. 2. When chemotherapy was administered as a preoperative or postoperative adjunct therapy, it has been at least 6 months since the final day of administration. (7) Previous radiotherapy for breast cancer corresponds to the following: 1. It has been at least 14 days after the final day of radiotherapy administration. (8)Agreement about the participation in the study will be obtained from the subject him/herself using the consent form.
Exclusion criteria
Exclusion criteria: A case that corresponds to any of the following is excluded from participating in this study as a subject. (1)HER2-positive breast cancer. (2)A case not indicated for endocrine therapy. (3)Any other case that a physician determines to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival overall survival time to treatment failure time to chemotherapy response rate health-related quality of life adverse events | — |
Countries
Japan
Contacts
Public ContactTomomi Fujisawa
Gunma Prefectural Cancer Center Breast oncology
Outcome results
None listed