OncoMatch/Clinical Trials/NCT07666555
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.
Is NCT07666555 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including CDK4/6 inhibitor and Culmerciclib for breast cancer.
Treatment: CDK4/6 inhibitor · Culmerciclib · Fulvestrant — To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
positive ER expression
Required: HER2 (ERBB2) wild-type (absence)
negative HER2 expression
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: CDK4/6 inhibitor combined with endocrine therapy — adjuvant or first-line metastatic
Received CDK4/6 inhibitor combined with endocrine therapy as adjuvant endocrine therapy, experienced recurrence or progression during or within 1 year after completion of adjuvant CDK4/6 inhibitor therapy, and did not receive subsequent endocrine therapy; OR recurrence or progression more than 1 year after completion of adjuvant endocrine monotherapy, followed by progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy; OR newly diagnosed locally advanced or metastatic disease, with disease progression after receiving CDK4/6 inhibitor combined with endocrine therapy as first-line salvage endocrine therapy
Lab requirements
Blood counts
Kidney function
Liver function
The functions of vital organs meet the requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07666555 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received CDK4/6 inhibitor combined with endocrine therapy.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages