Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer

Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer - Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012067

Enrollment

Registered

2013-10-25

Start date

2013-07-01

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 breast cancer

Interventions

Fulvestrant after Non Steroidal Aromatase Inhibitor (Anastrozole or Letrozole) failure

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histological confirmed invasive breast cancer by biopsy 2) Postmenopausal patients who fulfill at least one of the following as a condition of menopause 60 years of age or older 45 years of age or older with amenorrhea more than two years Provided that no hysterectomy bilateral oophorectomy 3) Estorogen receptor (ER) positive by Immunohistochemistrv(IHC; => 1%) confirmed by biopsy before treatment. 4) HER2 negative (IHC: 1+ or 0, or FISH: negative) by biopsy before treatment 5) Measurable lesion 6) Principal organs (bone marrow, heart, 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 <= 1.25 x Upper limit of facility reference Serum creatinine <= 1.25 x Upper limit of facility reference clinically normal range by cardiac function electrocardiogram

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy(2 regimen or more) or endocrine therapy 2) Taking radiation therapy for target lesion 3) Taking hormone replacement therapy or selective estrogen receptor 4) History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 5) Active double cancer 6) Inflammatory breast cancer 7) Bilateral breast cancer 8) History of allergic reactions for drugs and contract medium to be used in this study 9) Medication of investigational new drug for diseases other than breast cancer 10) Patients who are impossible to be enrolled due to psychological diseases or disorder 11) The case judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
To clarify biological factors and clinical pathological factors as CBR predictive factor of Fulvestrant	—

Secondary

Measure	Time frame
Clinical Benefit Rate of Fulvestrant CBR = Response Rate + Long SD Time To Progression Adverse Event Rate	—

Countries

Japan

Contacts

Public ContactTakanori Ishida

Tohoku university Breast and endocrine surgery

takanori@med.tohoku.ac.jp022-717-7214

Outcome results

None listed

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