Not Yet RecruitingPhase 2

Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer

272 participantsStarted 2026-02-01

Plain-language summary

▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Participants must be at least 19 years of age at the time of signing the informed consent.
✓. Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
✓. Patient has HR-positive/HER2-negative invasive breast cancer (based on most recently analyzed biopsy)
✓. HER2 status is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing, according to ASCO/CAP guidelines for HER2 testing (Wolff et al. 2018).
✓. HR status is defined as positive in ER expression by IHC, according to the relevant ASCO/CAP Guidelines (Allison et al. 2020)
✓. Patient must have received either at least 1 year of adjuvant abemaciclib or ribociclib.
✓. Recurrence of advanced breast cancer was diagnosed ≥1 year from the last dose of adjuvant CDK4/6 inhibitor.
✓. Patients must have received a minimum of 2 years of adjuvant endocrine therapy (either alone or in combination with CDK4/6 inhibitors)

Exclusion criteria

✕. Patients whose cancer recurs one year or later after completing adjuvant endocrine therapy
✕. Patients who have been free from endocrine therapy for at least 2 years
✕. Patient whose disease recurred during or within 1 year from adjuvant CDK4/6 inhibitor treatment.
✕. Patient who did receive adjuvant palbociclib irrespective of disease-free interval.
✕. Patients who did not receive adjuvant CDK4/6 inhibitor treatment or who received less than 1 year of adjuvant CDK4/6 inhibitor treatment.
✕. Patients who have received fulvestrant in adjuvant setting before randomization.
✕. Patients who have received any line of systemic treatment for advanced breast cancer is not eligible.
✕. Participant has not recovered from clinical, and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: participants with grade 2 taxane-induced neuropathy, any grade of alopecia, amenorrhea or other toxicities not considered a safety risk for the participant as per investigator's discretion, are allowed to enter the study.

What they're measuring

Progression Free Survival

Timeframe: Up to 5 years

Trial details

NCT IDNCT06849947

SponsorYeon Hee Park

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06-30

Contact for this trial

Yeon Hee Park, Ph.D

0234103459 yhparkhmo@gmail.com

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