Breast Cancer MetastaticNCT07076680
A Real-World Study in Patients With HR+/HER2- Advanced Breast Cancer
An observational study of Breast Cancer Metastatic and HR+/HER2- Advanced Breast Cancer, run by SciClone Pharmaceuticals at 1 site in China.
Trial 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-). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, HR+/HER2- Advanced Breast Cancer
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness in Patients With HR+/HER2- Advanced Breast Cancer: a Prospective, Noninterventional Real-world Study
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
- Keywords
- HR+/HER2- advanced breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endocrine therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The number and percentage of participants who experience any serious adverse event (SAE), defined per ICH-GCP and local regulatory standards.
Measured: 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.
Measured: 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.
Measured: From Day 1 (first dose) through the end of treatment (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Due to a strategic decision by the company, the study will not proceed, and no subjects have been enrolled to date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianli Zhao, Doctor, Principal investigator, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076680
- Sponsor's protocol ID
- RWS
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness in Patients With HR+/HER2- Advanced Breast Cancer: a Prospective, Noninterventional Real-world Study
- ClinicalTrials.gov ID
- NCT07076680
- Acronym / sponsor ID
- RWS
- Keywords
- HR+/HER2- advanced breast cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to a strategic decision by the company, the study will not proceed, and no subjects have been enrolled to date.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endocrine therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)
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).
3 secondary outcomes
Incidence of Serious Adverse Events (SAEs)
Time frame: From first dose until 30 days after last dose or end of follow-up
Rate of Dose Modifications Due to 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
Time frame: From Day 1 (first dose) through the end of treatment (up to 24 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianli Zhao, Doctor principal investigator
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic and HR+/HER2- Advanced Breast Cancer, run by SciClone Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.