HR+/HER2-breast CancerPhase 3NCT05889871

A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer

A Phase 3 study testing Standard endocrine therapy plus Apatinib in people with HR+/HER2-breast Cancer, run by Fudan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing. A randomized, controlled, open Phase III study to explore the efficacy and safety of Apatinib combined with standard endocrine therapy in adjuvant intensive… Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: HR+/HER2-breast Cancer
What is being tested?: Standard endocrine therapy plus Apatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 916 participants
Where: No sites listed yet
Study dates: 1 Jun 2023to 1 Jun 2026
Phase: Phase 3
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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged ≥18 years and ≤70 years;
Histologically confirmed HR+/HER2- invasive breast cancer (defined by immunohistochemical detection of ER \> 10% positive tumor cells were defined as ER positive, PR \> 10% positive tumor cells were defined as positive PR, and ER and/or PR were defined as positive HR. HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
Definition of SNF4 subtype: SNF4 subtype confirmed by digital pathology of H\&E sections;
High-risk early breast cancer, which was pathologically confirmed as HR+/HER2- and SNF4 subtypes; pT2-4N0-3M0;
Complete the adjuvant chemotherapy selected by the doctor;
No more than 16 months from surgery to randomization, and no more than 12 weeks after non-endocrine therapy;

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The functions of major organs are basically normal, meeting the following conditions:
The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥75×109 /L;
Biochemical examination shall meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);
ECOG score 0 or 1;
Fertile female subjects are required to use a medically approved contraceptive for the duration of the study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

bilateral breast cancer;
A history of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
transfer of any part;
Pregnant or lactating women, women of childbearing age can not effectively contraceptive;
Patients participating in other clinical trials;
Severe organ dysfunction (heart, lung, liver and kidney); 50% (cardiac hypertrophy); Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, myocardial infarction, or cerebrovascular accident) within 6 months before randomization; Diabetics with poor blood sugar control;

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Patients with a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), shall not be included in the group; If fecal occult blood (+), gastroscopy is required;
Abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days before the study;
Urine routine showed urine protein ≥++ or confirmed 24 hours urine protein quantity > 1.0g;
Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg).
Allergic constitution, or known allergic history of the drug components of the program;
Previous thyroid dysfunction;
Severe or uncontrolled infection;
Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders; The researchers determined that the patients were not suitable for the study.

About this study

Official title: A Randomized, Controlled, Open-label, Phase III Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer Based on SNF Molecular Classification

Read the detailed description

584 patients with lumofacial breast cancer (ER and PR positive, HER2 negative) who received surgery in the Breast Surgery Department of the Affiliated Cancer Hospital of Fudan University were previously collected. The main work was genome sequencing (514 cases of whole exon sequencing, 527 cases of OncoScan microarray), 573 cases of transcriptome sequencing, 228 cases of proteomics (TMT mass spectrometry), 384 cases of metabolomics (liquid chromatography), 439 cases of digital pathology, and partial paired single cell transcriptome sequencing. This group ranks as the largest Asian coelfacial breast cancer multiomics cohort to date. All patients could be divided into four categories by SNF algorithm fusion clustering, namely SNF1 (classical coelateral type), SNF2 (immune-mediated type), SNF3 (proliferative type) and SNF4 (receptor tyrosine kinase-driven type). Different types had unique multiomics and clinicopathological characteristics, which fully analyzed the molecular heterogeneity of coelateral type breast cancer.

Conditions: HR+/HER2-breast Cancer
Being tested: Standard endocrine therapy plus Apatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard endocrine therapy plus ApatinibDrug
Standard endocrine therapy plus Apatinib

Study groups in NCT05889871
Study group	Role	What they receive
Standard endocrine therapy plus Apatinib	Experimental	5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications. plus Apatinib, 250mg orally once a day; Receives: Drug: Standard endocrine therapy plus Apatinib
Standard endocrine therapy	Active comparator	5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications. Receives: Drug: Standard endocrine therapy plus Apatinib

What is being measured

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

3-year survival without invasive disease (iDFS)
3-year survival without invasive disease (iDFS)
Measured: 3 years

Secondary outcomes (4)

3-year distant disease free survival (DDFS)
3-year distant disease free survival (DDFS)
Measured: 3 years
5-year overall survival (OS)
5-year overall survival (OS)
Measured: 5 years
security
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
Measured: through study completion, an average of 1 year
PRO (patient reported outcome)
Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.
Measured: 5 years

Timeline

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

1 Jun 20231 Jun 2026

First posted5 Jun 2023
Study start1 Jun 2023 (estimated)
Primary completion1 Jun 2026 (estimated)
Study completion1 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HR+/HER2-breast CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 916 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05889871
Sponsor's protocol ID: SCHBCC-N050
Status last verified: Jun 2023
First submitted: 23 May 2023
Last updated: 5 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer

All HR+/HER2-breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Open-label, Phase III Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer Based on SNF Molecular Classification
ClinicalTrials.gov ID: NCT05889871
Acronym / sponsor ID: SCHBCC-N050
Conditions: HR+/HER2-breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 916 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 1 Jun 2023 (estimated)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Jun 2026 (estimated)
First posted: 5 Jun 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard endocrine therapy plus Apatinib	Experimental	Drug: Standard endocrine therapy plus Apatinib5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications. plus Apatinib, 250mg orally once a day;
Standard endocrine therapy	Active comparator	Drug: Standard endocrine therapy plus Apatinib5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Women aged ≥18 years and ≤70 years;
Histologically confirmed HR+/HER2- invasive breast cancer (defined by immunohistochemical detection of ER \> 10% positive tumor cells were defined as ER positive, PR \> 10% positive tumor cells were defined as positive PR, and ER and/or PR were defined as positive HR. HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
Definition of SNF4 subtype: SNF4 subtype confirmed by digital pathology of H\&E sections;
High-risk early breast cancer, which was pathologically confirmed as HR+/HER2- and SNF4 subtypes; pT2-4N0-3M0;
Complete the adjuvant chemotherapy selected by the doctor;

Key exclusion criteria (14 listed)

bilateral breast cancer;
A history of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
transfer of any part;
Pregnant or lactating women, women of childbearing age can not effectively contraceptive;
Patients participating in other clinical trials;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard endocrine therapy plus ApatinibStandard endocrine therapy plus Apatinib	Drug	Standard endocrine therapy, Standard endocrine therapy plus Apatinib

Primary outcome

3-year survival without invasive disease (iDFS)
Time frame: 3 years
3-year survival without invasive disease (iDFS)

4 secondary outcomes

3-year distant disease free survival (DDFS)
Time frame: 3 years
5-year overall survival (OS)
Time frame: 5 years
security
Time frame: through study completion, an average of 1 year
PRO (patient reported outcome)
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Individual participant dataSharing planned: No

Related trials for HR+/HER2-breast Cancer

Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard endocrine therapy plus Apatinib in people with HR+/HER2-breast Cancer, run by Fudan University.

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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

3-year survival without invasive disease (iDFS) (time frame: 3 years). 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 NCT05889871.

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 5 Jun 2023.