Optimal therapeutic strategies with CDK4/6 inhibitors based on the real world evidence in patients with HR-positive/HER2-negative advanced and metastatic breast cancer

Optimal therapeutic strategies with CDK4/6 inhibitors based on the real world evidence in patients with HR-positive/HER2-negative advanced and metastatic breast cancer - JBCRG-C10

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051975

Enrollment

400

Registered

2023-08-25

Start date

2023-10-01

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

Hormone receptor positive HER2 negative advanced metastatic breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Women over 18 years old 2)Menopausal status is not required 3)Diagnosed with advanced metastatic breast cancer (AMBC) 4)Confirmed estrogen receptor (ER) positive or progesterone receptor (PgR) positive 5)Confirmed HER2 negative 6)Palbociclib (PAL) or abemaciclib (ABE) initiated in combination with any endocrine therapy as primary or secondary treatment for AMBC between January 1, 2019 and December 31, 2021 7)PAL or ABE administered for at least 2 months 8)No anticancer therapy prior to initiation of PAL or ABE as AMBC treatment 9)If PAL or ABE was used as perioperative treatment, the period from the date of its last administration to the date of AMBC diagnosis is at least 6 months 10)Has not expressed non-participation in the study

Exclusion criteria

Exclusion criteria: non

Design outcomes

Primary

Measure	Time frame
Chemotherapy-free survival (CFS)	—

Secondary

Measure	Time frame
1.Overall survival: OS 2.CFS 3.real world progression-free survival: rwPFS 4. Time to treatment discontinuation : TTD 5. Background factors for CDK4/6 inhibitors + endocrine therapy 6. CDK4/6 inhibitor + endocrine therapy post-treatment TTD 7. Exploratory study: prediction factors of response to CDK4/6 inhibitor + endocrine therapy	—

Countries

Japan

Contacts

Public ContactJun Fukase

Japan Breast Cancer Research Group(JBCRG) Head office

JBCRG-QAG@jbcrg.jp03-6264-8873

Outcome results