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

NCT07076680 | Withdrawn

• 1 other identifier: RWS
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

HR+/HER2- advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  The number and percentage of participants who experience any adverse event (AE) during treatment, regardless of severity or causality. Events will be coded using standard terminology (e.g., MedDRA).

  From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)

Secondary Outcomes (3)

• Incidence of Serious Adverse Events (SAEs)

  From first dose until 30 days after last dose or end of follow-up

• Rate of Dose Modifications Due to Adverse Events

  From Day 1 (first dose) through the end of treatment (up to 24 months)

• Rate of Discontinuation Due to Adverse Events

  From Day 1 (first dose) through the end of treatment (up to 24 months)

Study Arms (1)

endocrine therapy

Eligibility Criteria

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

Study Population

This study will include adults with advanced or metastatic breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-), and has an ESR1 gene mutation. Participants will be receiving elacestrant as part of routine clinical care. They may be receiving treatment at cancer centers or hospitals across multiple regions in China. Both premenopausal and postmenopausal individuals may be eligible, based on local clinical practice.

You may qualify if:

• \. 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.
• \. 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).
• \. 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.
• \. previous treatment with at least one endocrine therapy, either as monotherapy or in combination with another drug, at an advanced stage.
• \. have a life expectancy greater than 3 months and normal organ function (as assessed by the investigator).

You may not qualify if:

• \- 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.
• \. Other conditions that the investigator considers inappropriate for enrollment.

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (1)

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

Guangzhou, China

Location

Study Officials

• Jianli Zhao, Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)