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Therapeutic effect of darceline on HR+ advanced breast cancer: Real-world research on security

Therapeutic effect of darceline on HR+ advanced breast cancer: Real-world research on security

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058860
Enrollment
Unknown
Registered
2022-04-18
Start date
2022-04-30
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Case series:Dalceli: 150mg orally, every 28 days is a treatment cycle, in which the first 3 weeks (day 1 to day 21) are taken continuously, and the last 1 week (day 22 to day 28) is rested (no medicat

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal female patients >=18 years old, who meet one of the following: (1) bilateral ovariectomy has been performed in the past, or the age is >=60 years old; (2) Age = 1% (verified by the researchers in the experimental center); 3. The score of the physical condition of Eastern Cancer Cooperative Group (ECOG) is 0-2; 4. Women of childbearing age must have a serum pregnancy test within 28 days before joining the group, and the result is negative, and they are willing to adopt a medically recognized high-efficiency contraceptive measure during the study period and within one year after the last administration of the study drug; 5. Patients who have already started to receive the treatment plan containing dalcicil before joining the group can also join the study if the baseline information, previous treatment and tumor curative effect evaluation information of the patients are complete; 6. With my consent and signed informed consent, I am willing and able to follow the planned visit, research and treatment plan, laboratory examination and other test procedures;

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating female patients; 2. Patients who are participating in other studies; 3. The researcher thinks it is not suitable for the selected patients.

Design outcomes

Primary

MeasureTime frame
Adverse events (AE);Severe adverse events (SAE);

Secondary

MeasureTime frame
Progression-free survival (PFS);Overall survival (OS);Objective response rate (ORR);Clinical benefit rate (CBR);

Countries

China

Contacts

Public ContactZhong Jincai

The First Affiliated Hospital of Guangxi Medical University

13907719863@163.com+86 13907719863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026