A Real-World Study in Patients With HR+/HER2- Advanced Br... | NCT07076680

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

NCT07076680

Sponsor

SciClone Pharmaceuticals

Status

Withdrawn

Last Update Posted

Nov 28, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Cancer Metastatic
HR+/HER2- Advanced Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to a strategic decision by the company, the study will not proceed, and no subjects have been enrolled to date.

Expanded Access Info

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Jun 17, 2025

First Submission Date that Met QC Criteria

Jul 21, 2025

First Posted Date

Jul 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Nov 28, 2025Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
endocrine therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of Serious Adverse Events (SAEs)	The number and percentage of participants who experience any serious adverse event (SAE), defined per ICH-GCP and local regulatory standards.	From first dose until 30 days after last dose or end of follow-up
Rate of Dose Modifications Due to Adverse Events

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample