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A real world study of fulvestrant(qingkeyi) in hormone receptor positive advanced breast cancer

A real world study of fulvestrant(qingkeyi) in hormone receptor positive advanced breast cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046365
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

breast cancer

Interventions

Test group:Fulvestrant

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed advanced breast cancer, including inoperable locally advanced breast cancer, newly diagnosed stage IV (staging according to AJCC 8th Edition), or recurrent / metastatic breast cancer; 2. Estrogen receptor (ER) positive and (or) progesterone (PR) receptor positive; 3. Had at least one measurable lesion (RECIST 1.1); 4. The patient voluntarily joined this project to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. HER2 overexpression or gene amplification, such as immunohistochemical detection of HER2 (3 +) or fluorescence in situ hybridization positivity; 3. Serious harms to patient safety or concomitant diseases affecting the completion of the study by the patient, as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Progression free survival time;

Secondary

MeasureTime frame
Objective response rate;Overall Survival time;Treatment failure time;

Countries

China

Contacts

Public ContactZhong Jincai, Deng Lili

The First Affiliated Hospital of Guangxi Medical University

570435088@qq.com+86 13907719863

Outcome results

None listed

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