Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study

Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study - SBP-11

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035533

Enrollment

Registered

2019-01-13

Start date

2018-12-01

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

breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer pretreated with no hormonal therapy for MBC. 1 Adaptation for Fulvestrant and CDK4/6 inhibitor and the informed consent is obtained. 2 age >=20,female, regardless of menstrual status. 3 locally advanced/ metastatic breast cancer histologically confirmed 4 Hormone receptor positive breast cance confirmed by Immunohistochemically. 5 HER2 negative breast cance confirmed by Immunohistochemically or ISH. 6 ECOG PS: 0-2 7 non-hematological AE( CTCAE v4.0-JCOG) <= grade 2 7 no major organ dysfunction nor bone marrow dysfunction. 8 with or without evaluable lesions (with evaluable lesions preferred) 9 1st line hormonal therapy for MBC ( 1regimen fo chemotherapy is allowed) 10 with documented informed consent.

Exclusion criteria

Exclusion criteria: 1 with life-threatenings 2 symptomatic brain metastasis 3 eligible for inclusion criteria of PALOMA-3 4 pretreated with hormonal therapy for MBC 5 pregnancy or breast feeding or unwilling to contraception 6 long QT syndrome or similar diseases 7 Electrolyte abnormality causing long QT syndrome 8 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months 9 obvious pulmonary fibrosis or interstitial pneumonia 10 active infection 11 other severe comorbidity 12 another active cancer 13 allergic for fulvestrant or CDK4/6 inhibitor 14 other inappropriate patients

Design outcomes

Primary

Measure	Time frame
PFS	—

Secondary

Measure	Time frame
CBR, OS, ORR, TTF, Safety, compliance	—

Countries

Japan

Contacts

Public ContactNaruto Taira

Setouchi Breast Project Comprehensive Support Organization Clinical trial committee

info@setouchi-bp.com086-235-7265

Outcome results