An observational study in Breast Cancer Metastatic and HR+/HER2- Advanced Breast Cancer, sponsored by SciClone Pharmaceuticals. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by SciClone Pharmaceuticals · Observational
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →SciClone Pharmaceuticals is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. must have a or cytologically confirmed diagnosis of breast cancer and evidence of locally advanced or disease that is not amenable to surgical resection.
2. Women or men ≥ 18 years of age. 3. must be confirmed as HR+ and - by local laboratory tests. Confirmation of this status can be done by a first visit tissue sample or a post-treatment sample (recent 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 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 .
3. Other conditions that the investigator considers inappropriate for enrollment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)
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.
Time frame: From first dose until 30 days after last dose or end of follow-up
Rate of Dose Modifications Due to Adverse Events
The number and percentage of participants who require dose reductions or interruptions due to treatment-related adverse events.
Time frame: From Day 1 (first dose) through the end of treatment (up to 24 months)
Rate of Discontinuation Due to Adverse Events
The number and percentage of participants who permanently stop treatment due to treatment-related adverse events.
Time frame: From Day 1 (first dose) through the end of treatment (up to 24 months)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Feb 2027, 18 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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SciClone Pharmaceuticals