Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer

Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer - Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043917

Enrollment

Registered

2021-04-14

Start date

2021-04-01

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: Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer patients who have completed postoperative hormone therapy for more than 1 year or who have not been treated with hormone therapy and who meet all of the following criteria are included. 1) Histologically confirmed advanced/metastatic breast cancer 2) Premenopausal or postmenopausal patients aged 20 years or older 3) Confirmed diagnosis of ER positive breast cancer 4) Confirmed diagnosis of HER2 negative breast cancer 5) Adequate organ and bone marrow function 6) Easter Cooperative Oncology Group [ECOG]0-1 7) No prior systemic chemotherapy or 1st line prior systemic chemotherapy 8) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Recurrence during postoperative hormone therapy or within 1 year from completion of treatment 2) Known uncontrolled or symptomatic central nervous system metastases 3) Patients with advanced symptomatic visceral spread that are at risk of life threatening complication in the short term 4) Prior endocrine therapy for advanced/metastatic breast cancer 5) Known interstitial lung disease on imaging 6) Known uncontrolled infection 7) Current pregnancy and lactation or possibility of pregnancy 8) Known drug allergy to any of study drugs 9) Assessment by investigator that subject unable to comply with protocol

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
1)Time to treatment failure 2)Overall survival 3)Objective response rate 4)Clinical benefit rate 5)Parcentage of participants with over Grade 3 adverse events	—

Countries

Japan

Contacts

Public ContactYutaka Mizuno

Yokkaichi Municipal Hospital Breast Surgery

mizunoy729@yokkaichihp01.jp059-354-1111

Outcome results