NIPH Clinical Trials Search

JBCRG-S04

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	hormone receptor-positive, HER2-negative advanced metastatic breast cancer (AMBC)
Date of first enrollment	03/06/2025
Target sample size	750
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	the Time to Next Treatment (TTNT) from the start of first-line treatment to the start of second-line treatment in the ABE+ET combination group of the C10 Cohort
Secondary Outcome	Secondary endpoints include Chemotherapy Free Survival (CFS), which is the period until the start of chemotherapy, in the ABE+ET combination group of the C10 Cohort and the ABCD Cohort.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender
Include criteria	Eligible subjects enrolled in JBCRG-C10 (C10 Cohort) or ABCD Project (ABCD Cohort) Eligibility Criteria C10 Cohort: Subjects enrolled in JBCRG-C10 and meeting the following criteria: 1.ABE was initiated as first-line treatment* for AMBC in combination with an aromatase inhibitor (AI) or fulvestrant (FUL) as ET. *Definition of first-line treatment: The first treatment after being diagnosed with AMBC. 2.No intention of refusal for secondary use of data. ABCD Cohort: Subjects enrolled in the ABCD project and meeting the following criteria: 1.Menopausal status is not considered. 2.Confirmed to be estrogen receptor (ER) positive (1% or more) or progesterone receptor (PgR) positive (1% or more). 3.Confirmed to be HER2 negative (Definition of HER2 negative: IHC 1+ or less, or FISH/DISH negative). 4.ABE was initiated as first-line treatment* for AMBC in combination with AI or FUL as ET (ABE+ET combination group). Alternatively, AI or FUL as ET was initiated as first-line treatment (ET alone group). *Definition of first-line treatment: The first treatment after being diagnosed with AMBC. 5.In the case of the ET monotherapy group, ET was administered as first-line treatment for more than 2 months (in case of the comparative analysis with the C10 cohort). 6.If ABE was used as perioperative treatment, the period from the last administration date to the AMBC diagnosis date is 6 months or more. 7.Treatment was initiated on or after January 1, 2019. 8.No indication of refusal for secondary use of data.
Exclude criteria	None