OncoMatch/Clinical Trials/NCT06167694
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
Is NCT06167694 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies HRS-8080; Dalpiciclib Isethionate Tablets for unresectable or metastatic breast cancer.
Treatment: HRS-8080; Dalpiciclib Isethionate Tablets — This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: endocrine therapy — advanced/metastatic
Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past
Cannot have received: nitrosourea
Received nitrosourea or mitomycin within 6 weeks before the first dose in this study
Cannot have received: mitomycin
Received nitrosourea or mitomycin within 6 weeks before the first dose in this study
Cannot have received: cytotoxic chemotherapy
cytotoxic drugs ... within 4 weeks before the first medication
Cannot have received: immunotherapy
immunotherapy ... within 4 weeks before the first medication
Cannot have received: targeted therapy
targeted therapy ... within 4 weeks before the first medication
Cannot have received: anti-tumor traditional Chinese medicine
anti-tumor traditional Chinese medicine ... within 4 weeks before the first medication
Cannot have received: other clinical investigational drugs
other clinical investigational drugs within 4 weeks before the first medication
Cannot have received: endocrine therapy
He received endocrine therapy ... within 2 weeks before the first dose
Cannot have received: palliative radiotherapy
He received ... palliative radiotherapy within 2 weeks before the first dose
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06167694 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior nitrosourea, mitomycin, cytotoxic chemotherapy disqualifies patients from 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