Dalpiciclib for hormone receptor–positive advanced or metastatic breast cancer

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study

This study will test dalpiciclib-containing regimens in adults with hormone receptor–positive advanced or metastatic breast cancer to see if they control the disease and are safe.

Quick facts

• Study type: Observational
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT05578053 on ClinicalTrials.gov

What this trial studies

This is a multicenter, observational real-world study enrolling patients with HR-positive locally advanced or metastatic breast cancer who are receiving or planning to receive dalpiciclib-containing regimens. The protocol planned to include about 420 patients regardless of prior systemic therapy, with treatment choices and regimens determined by the treating physician. Participants undergo routine imaging and safety assessments during treatment, and investigators record outcomes according to usual clinical practice. The study captures effectiveness and tolerability of dalpiciclib in a broad, real-world patient population.

Who should consider this trial

Good fit: Adults (≥18 years) with pathology-confirmed hormone receptor–positive locally advanced or metastatic breast cancer who are appropriate for systemic therapy and have ECOG performance status 0–2, including premenopausal patients willing to use LHRH agonist therapy.

Not a fit: Patients whose tumors are not hormone receptor–positive, those eligible for curative surgery or radiotherapy, or those with contraindications to CDK4/6 inhibitors may not be expected to benefit from dalpiciclib in this setting.

Why it matters

Potential benefit: If successful, dalpiciclib-containing regimens could offer an additional effective and tolerable treatment option to help control disease in HR-positive advanced breast cancer patients.

How similar studies have performed: Other CDK4/6 inhibitors have demonstrated clinical benefit in HR-positive advanced breast cancer, and dalpiciclib is an investigational agent with emerging real-world and clinical data supporting its activity.

Eligibility criteria

Inclusion Criteria:

1. age ≥ 18 years, postmenopausal or premenopausal female or male patients, female patients must meet one of the following: a) previous bilateral oophorectomy, or age ≥ 60 years; b) age \< 60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; c) premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist therapy during the study;
2. pathological examination confirmed HR-positive male/female breast cancer patients, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy with the purpose of cure;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Serum pregnancy test must be performed within 28 days before enrollment in women of childbearing age and the result is negative,And male/female patients are willing to use a medically recognized highly effective contraceptive during the study and within 1 year after the last dose of study drug;
5. non-pregnant or non-lactating female patients；
6. do not participate in other ongoing studies at the same time ；
7. agreed by the patient himself or her legal representative and have signed an informed consent form, willing and able to comply with scheduled visits, study treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria:

1. any evidence of serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections, including hepatitis B, C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney damage, which, in the opinion of the investigator, would greatly alter the balance of wind benefit/risk.
2. at the time of initiation of dalpiciclib treatment, the patient has not recovered from any CTCAE grade ≥ 3 toxicity caused by previous treatment
3. known history of hypersensitivity to dalpiciclib or excipients or drugs with similar chemical structure to dalpiciclib
4. patients who are considered unsuitable for inclusion by the investigator.

Where this trial is running

Shijiazhuang, Hebei

• The Fourth hospital of Hebei University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Principal investigator: Cuizhi Geng Cuizhi Geng, archiater — Hebei Medical University Fourth Hospital
• Study coordinator: cuizhi Geng Cuizhi Geng, archiater

Conditions Breast Cancer