Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer

NCT05578053 | Recruiting

• 1 other identifier: 2022106
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  progression free survival

  2 years

• AE

  the incidence of adverse event

  2 years

Study Arms (1)

locally advanced/metastatic HR+ breast cancer patients

HR+ postmenopausal or premenopausal and locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy.

Drug: Dalpiciclib

Interventions

Dalpiciclib DRUG

a new, orally administered, selective CDK4/6 inhibitor

Also known as: SHR-6390

locally advanced/metastatic HR+ breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HR+ postmenopausal/premenopausal locally advanced/metastatic breast cancer patients who had received or had not received prior systemic therapy were planned to be enrolled in the study

You may qualify if:

• 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;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• 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;
• non-pregnant or non-lactating female patients；
• do not participate in other ongoing studies at the same time ；
• 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.

You may not qualify if:

• 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.
• at the time of initiation of dalpiciclib treatment, the patient has not recovered from any CTCAE grade ≥ 3 toxicity caused by previous treatment
• known history of hypersensitivity to dalpiciclib or excipients or drugs with similar chemical structure to dalpiciclib

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth hospital of Hebei University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cuizhi Geng Cuizhi Geng, archiater

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cuizhi Geng Cuizhi Geng, archiater

CONTACT

+8613503216325; gengcuizhi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Hebei Medical University Fourth Hospital

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)