Dalpiciclib for hormone receptor–positive advanced or metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gengcuizhi@hotmail.com
• Phone: +8613503216325

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.