A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)

A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29) - SBCCSG-29:Fulvestrant observational study

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009110

Enrollment

100

Registered

2012-10-15

Start date

2012-10-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Postmenopausal breast cancer. 2.Histological confirmation of breast cancer. 3.Histologically proven invasive breast cancer. 4.Patients who is receiving or planning to receive Fulvestrant therapy. 5.Prior endocrine therapy for breast cancer besides Fulvestrant therapy. 6.Estrogen receptor positive (>1% by IHC). 7.Adequate marrow, cardiac, kidney and liver function. 8.In principle signed written informed consent was obtained from patients.

Exclusion criteria

Exclusion criteria: 1.Current or prior double cancer within 5 years. 2.Non-invasive breast cancer. 3.Inflammatory breast cancer. 4.An existing serious, uncontrolled cardiac disease. 5.Brain metastasis.

Design outcomes

Primary

Measure	Time frame
Time to treatment failure(TTF)	—

Secondary

Measure	Time frame
Overall survival(OS), Clinical benefit rate(CBR), Response rate(RR), Safety	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' Mammo Clinic)

toshikai@sbccsg.org048-600-1722

Outcome results