Under construction – not a live service
Sign in
WithdrawnNo phase

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

Key facts

Who runs it
SciClone Pharmaceuticals
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Withdrawn
Started
1 Aug 2025
Expected to end
1 Jul 2027
Type of study
Observational
Record updated
28 November 2025
Why it stopped
Due to a strategic decision by the company, the study will not proceed, and no subjects have been enrolled to date.

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 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; 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)

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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-).

Read full original descriptionShow less

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

The group in the trial

  • endocrine therapy

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Effectiveness in Patients With HR+/HER2- Advanced Breast Cancer: a Prospective, Noninterventional Real-world Study
Record updated
28 November 2025