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HR+/HER2- Advanced or Metastatic Breast CancerNCT07476170

Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China

An observational study of HR+/HER2- Advanced or Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of sufficient evidence for ribociclib as a most recently marketed drug in the real-world… Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
14,000 participants
Where
1 siteChina
Study dates
20 Mar 2026to 1 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HR+/HER2- ABC adult patients (aged 18 years or older) with 1L treatment being initiated between Jan. 1, 2024 and Jan. 1, 2027, and have at least 3 months of follow-up records after the initiation of 1L treatment.

Who may be able to join

  • Diagnosed with HR+/HER2- ABC:
  • HR+ is defined as ER+ or PR+, and HER2+ is defined as immunohistochemistry 3+, or 2+ with positive in situ hybridization (amplification). Advanced or metastatic breast cancer is defined as having a documented inoperable clinical or pathological stage IIIB, IIIC, or IV, or the records indicating distant metastasis.
  • Initiation of 1L anti-cancer treatment between Jan. 1, 2024 and Jan. 1, 2027; Defined as having records of systemic anti-cancer treatment in disease course records or order records within 90 days after the initial diagnosis of ABC, and receiving the first dose between Jan. 1, 2024 and Jan. 1, 2027, as recorded in the NATDSS database.
  • Aged 18 years or older at the time of receiving the 1L treatment; Definition: The initiation date (index date) of 1L treatment is defined as the initiation date of systemic anti-cancer treatment for HR+/HER2- ABC first recorded in the database. Age will be preferentially calculated based on the date of birth (or year of birth) and the initiation date of 1L treatment in the database. If the birth information is not included in the database but shown in an "Age" field in the medical visit/hospitalization record associated with 1L treatment, this age field will be used as the basis for age.
  • At least 3 months of follow-up records after the initiation of 1L treatment. Defined as having at least one outpatient or inpatient medical visit record in the NATDSS at least 3 months after the index date.

Who cannot join

  • Patients with any other concomitant invasive malignancies Defined as patients meeting any of the following conditions based on their diagnosis records in the cancer registry/medical database used for the study: 1. Within 5 years before the diagnosis of HR+/HER2- ABC, there is a diagnosis record of invasive malignancy other than breast cancer in the database (based on the International Classification of Diseases [ICD] diagnosis code or cancer registry code), and the diagnosis is not carcinoma in situ or benign/borderline tumor; 2. On the day of, or within 3 months after, the diagnosis of HR+/HER2- ABC, there is a new diagnosis record of invasive malignancy at another site (also based on the ICD diagnosis code or cancer registry code) indicating a concomitant active malignancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

China1 site, 1 recruiting

  • Novartis Investigative SIte

    Bingjie, Beijing Municipality, 100021

    Recruiting

Other trials in China

About this study

Official title: Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China: A Retrospective Analysis Based on a Database

This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of sufficient evidence for ribociclib as a most recently marketed drug in the real-world setting.

Read the detailed description

This study is a longitudinal, non-interventional, retrospective, and observational study based on secondary real-world data in the National Anti-Tumor Drug Surveillance System (NATDSS) database. The study will not involve any active intervention, randomization, or control group.

All analyses will be conducted using Electronic Health Record (EHR) routinely collected in clinical practice and additional secondary data sources

Keywords
HR+/HER2- advanced or metastatic breast cancer, China,, NIS
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of first-line treatment regimens

    Proportion of patients receiving each first line treatment category and specific regimen

    Measured: Up to 39 months

  2. Proportion of patients with treatment changes

    Proportion of patients who discontinue or switch first line treatment

    Measured: Up to 39 months

  3. Time to treatment initiation, time to discontinuation, and time to next line therapy

    Time to treatment initiation (TTI), time to discontinuation (TTD), and time to next-line therapy (TTNT)

    Measured: Up to 39 months

  4. Proportion of patients by initial CDK4 6 inhibitor dose

    Proportion of patients treated with a CDK4 6 inhibitor, stratified by initial dose level

    Measured: Up to 39 months

  5. Proportion of patients with dose modifications of CDK4/6 inhibitor therapy

    Proportion of patients treated with CDK4/6 inhibitor who experience any dose modification (including dose reduction and interruption)

    Measured: Up to 39 months

  6. Time to first dose modification of CDK4/6 inhibitor therapy

    Time from initiation of CDK4/6 inhibitor therapy to the first dose modification, including dose reduction or interruption

    Measured: Up to 39 months

Secondary outcomes (5)

  1. rwPFS of 1L treatment patterns

    rwPFS is defined as the duration from the initiation date of 1L treatment to documented disease progression or death from any cause. If a patient has not experienced disease progression or death, the last confirmed survival time will be used as the censoring time to calculate the rwPFS censoring duration

    Measured: Up to 39 months

  2. rwPFS of HR+/HER2- ABC patients

    rwPFS of HR+/HER2- ABC patients adhering or not adhering to the highest level of first-line treatment recommendation in the guidelines in the real-world setting based on the NATDSS database

    Measured: Up to 39 months

  3. rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens

    rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens in the real-world setting based on the NATDSS database

    Measured: Up to 39 months

  4. Number of subjects with AESIs

    AESIs under different treatment patterns, including:

    • Hematology: neutropenia, leukopenia, anemia, and thrombocytopenia;
    • Gastrointestinal tract: diarrhea, nausea, vomiting, stomatitis/mucositis;
    • QTc prolongation;
    • Hepatotoxicity: alanine transaminase (ALT)/aspartate transaminase (AST) increased, and total bilirubin increased.

    Measured: Up to 39 months

  5. Baseline demographics

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start20 Mar 2026
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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
Retrospective
Enrolment
14,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476170
Sponsor's protocol ID
CLEE011ACN01
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HR+/HER2- Advanced or Metastatic Breast Cancer, run by Novartis 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 1 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of first-line treatment regimens (time frame: Up to 39 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07476170.

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 2 Apr 2026.

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