Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer

Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer - Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012153

Enrollment

Registered

2013-11-01

Start date

2014-01-20

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

ER positive postmenopausal advanced / recurrence breast cancer

Interventions

Fulvestrant

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Postmenopausal breast cancer patient after progression of prior hormonal therapy patients who fulfill at least one of the following as a condition of menopause 55 years of age or older 45 years of age or older with amenorrhea more than two years Provided that no hysterectomy bilateral oophorectomy 2)Estorogen receptor(ER) positive by Immunohistochemistry(IHC => 1%) 3)HER2 negative (IHC 1+ or 0, or FISH negative) 4)Measurable lesion 5)Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved White blood cell count => 3,000/mm3 or Neutrophil count => 1,500/mm3 Platelet count => 100,000/mm3, Hemoglobin => 9.0 g/dL AST, ALT <= 1.5 x Upper limit of facility reference Total bilirubin <= 1.25 x Upper limit of facility reference ALP <= 1.5 x Upper limit of facility reference Serum creatinine <= 1.25 x Upper limit of facility reference clinically normal range by cardiac function electrocardiogram 6)ECOG performance status (P.S.) 0, 1 or 2 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Taking hormone replacement therapy or selective estrogen receptor 2)History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 3)Active double cancer 4)Inflammatory breast cancer 5)Bilateral breast cancer 6)History of allergic reactions for drugs and contract medium to be used in this study 7)Medication of investigational new drug for diseases other than breast cancer 8)Patients who are impossible to be enrolled due to psychological diseases or disorder 9)The case judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
Clinical Benefit Rate of Fulvestrant CBR = Response Rate + Long SD (SD>=24week)	—

Secondary

Measure	Time frame
Bone Mineral Density(BMD) before/after treatment of Fulvestrant Bone metabolism maker before/after treatment of Fulvestrant Change of QOL before/after treatment of Fulvestrant Adverse Event Rate	—

Countries

Japan

Contacts

Public ContactHideji Masuoka

Sapporo-Kotoni Breast Clinic Breast surgery

hmbreast@vmail.plala.or.jp011-622-2221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026