A Real-World Study in Patients With HR+/HER2- Advanced Breast Cancer

NCT ID: NCT07076680

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-07-01

Brief Summary

The goal of this observational study is to learn about the safety and effectiveness of people with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-).

Participants will:

Allow researchers to collect medical data during routine care

Be followed for signs of treatment effectiveness and any medical problems that happen while taking the drug

Conditions

Breast Cancer Metastatic; HR+/HER2- Advanced Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

endocrine therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 1. must have a histologically or cytologically confirmed diagnosis of breast cancer and evidence of locally advanced or metastatic disease that is not amenable to surgical resection.

2. Women or men ≥ 18 years of age. 3. must be confirmed as HR+ and HER2- by local laboratory tests. Confirmation of this status can be done by a first visit tissue sample or a post-treatment sample (recent biopsy sample preferred if available).

4. Testing to confirm ESR1 mutation positivity should be performed on tumor DNA taken from tissue samples or circulating tumor DNA (ctDNA) obtained from plasma samples using a well-validated assay. Accept the results of the central laboratory or local laboratory tests, and in the event of inconsistency between the two test results, the investigator determines whether enrollment is possible.

5. previous treatment with at least one endocrine therapy, either as monotherapy or in combination with another drug, at an advanced stage.

6. have a life expectancy greater than 3 months and normal organ function (as assessed by the investigator).

Exclusion Criteria

• 1. Pregnant or lactating females. 2. Known difficulty tolerating oral medications, or the presence of conditions that would interfere with the absorption of oral medications or allergies to medications and their excipients.

3. Other conditions that the investigator considers inappropriate for enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SciClone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianli Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, , China

Countries

China

Other Identifiers

RWS

Identifier Type: -

Identifier Source: org_study_id