Breast CancerPhase 3NCT07382687
Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype
A Phase 3 study testing SHR-A1811 and Famitinib+SHR-A1811 in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. This study aims to investigate the efficacy and safety of Famitinib combination with SHR-A1811 in CDK4/6 inhibitors-resistent advanced HR+/HER2- breast cancer with SNF4 subtype. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-A1811 and Famitinib+SHR-A1811
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2026to 31 Dec 2029
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-70 years old;
- Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER >10% of tumor cells positive by immunohistochemistry is defined as ER positive, PR >10% of tumor cells positive by immunohistochemistry is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 low expression or ultra-low expression [FISH/CISH- and IHC+/++ or IHC 0 but with ≤10% of tumor cells showing incomplete and weak cell membrane staining]);
- SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections and artificial intelligence;
- Locally advanced breast cancer (unresectable locally) or recurrent and metastatic breast cancer;
- Have used CDK4/6 inhibitors in the recurrent and metastatic stage, or have relapsed and metastasized within 1 year of adjuvant CDK4/6 inhibitor use;
- At least one measurable lesion according to RECIST 1.1 criteria (≥20 mm by conventional CT scan, ≥10 mm by spiral CT scan, and the measurable lesion has not received radiotherapy), or in the absence of measurable lesions, have non-measurable osteolytic or mixed (osteolytic + osteoblastic) bone lesions;
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- Basic normal major organ function, meeting the following conditions: (a) Blood routine examination standards need to meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109/L; PLT ≥75×109/L;(b) Biochemical examination needs to meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; if there is liver metastasis, ALT and AST ≤5×ULN; serum Cr ≤1.5×ULN, endogenous creatinine clearance rate >50 ml/min (Cockcroft-Gault formula);(c) Electrocardiogram: Fridericia's corrected QT interval (QTcF) < 450 ms for men and < 470 ms for women;
- ECOG score ≤2, and expected survival ≥3 months;
- Female subjects who are capable of bearing children need to adopt a medically approved contraceptive measure during the study treatment period and for at least 3 months after the last use of study medication;
- Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up
Who cannot join
- Uncontrolled central nervous system metastasis (referring to symptoms or the need for corticosteroids or mannitol to control symptoms);
- Left ventricular ejection fraction (LVEF) <50% (as determined by echocardiography);
- History of any of the following cardiac diseases: (1) angina pectoris; (2) clinically significant arrhythmia requiring medication; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease deemed unsuitable for participation in this trial by the investigator;
- previously suffered from clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or have been found to have suspected such diseases during screening period examinations;
- Individuals who have received radiotherapy, chemotherapy, surgical treatment (excluding minor outpatient surgeries such as placement of vascular access) or other targeted and immunotherapy treatments for advanced HR+/HER2- breast cancer within 3 weeks prior to the first administration of study drugs;
- Individuals who have ongoing ≥ Grade 1 adverse reactions due to previous treatments. Exceptions to this include hair loss or conditions that the investigator deems should not be excluded. Such cases should be clearly documented in the investigator's notes;
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- Pregnant or lactating patients;
- Individuals who have had malignant tumors within the past three years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Significant comorbidities, including mental illnesses that the investigator believes may adversely affect the patient's participation in the study;
- Patients with a history of gastrointestinal bleeding within the past 6 months or a clear tendency for gastrointestinal bleeding, such as esophageal varices with bleeding risk, localized active ulcer lesions, and occult blood in stool ≥ (++), are not eligible for enrollment; if occult blood in stool is (+), gastroscopy is required;
- Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days before participating in this study;
- Patients with imaging findings indicating tumor invasion around important blood vessels or, in the judgment of the investigator, a high likelihood of tumor invasion during treatment causing fatal massive hemorrhage;
- Patients who have experienced arterial/venous thromboembolic events within one year before screening, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis (excluding cases where venous thrombosis caused by venous catheterization during previous chemotherapy has been judged by the investigator to have healed), and pulmonary embolism;
- Patients with urine routine test showing urine protein ≥++ or confirmed 24-hour urine protein quantitation >1.0g;
- Patients with hypertension who cannot be brought to normal range by antihypertensive medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);
- Patients with swallowing difficulties, chronic diarrhea, and intestinal obstruction, which affect drug administration and absorption in various ways;
- Patients with third-space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites);
- Patients with allergic constitution, or known history of allergy to components of the study drugs; or patients allergic to other monoclonal antibodies;
- Patients with known active HBV or HCV infection or HBV DNA ≥500, or chronic phase with abnormal liver function;
- Any other situations where the investigator deems the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, 200032
Zhimin Shao, +8808 +86-021-64175590, zhimingshao@yahoo.com
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Trial of Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. This study aims to investigate the efficacy and safety of Famitinib combination with SHR-A1811 in CDK4/6 inhibitors-resistent advanced HR+/HER2- breast cancer with SNF4 subtype.
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811, Famitinib+SHR-A1811
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811 4.8mg/kg iv q3w
Famitinib+SHR-A1811Drug
Famitinib 10mg po qd SHR-A1811 4.8mg/kg iv q3w
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | SHR-A1811 Receives: Drug: SHR-A1811 |
| Experimental | Experimental | Famitinib+SHR-A1811 Receives: Drug: Famitinib+SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS) Based on Investigator Assessment
Measured: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Secondary outcomes (6)
Overall survival (OS)
Measured: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Objective response rate (ORR)
Measured: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Clinical benefit rate(CBR)
Measured: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Duration of Response(DOR)
Measured: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Time to Response(TTR)
Measured: from randomization to the achievement of first objective response, up to approximately 3 years
Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(TESAEs)
Measured: From first dose of study drug (Day 1) up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start26 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382687
- Sponsor's protocol ID
- SCHBCC-N099
- Other IDs
- MA-BC-III-133
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Trial of Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype
- ClinicalTrials.gov ID
- NCT07382687
- Acronym / sponsor ID
- SCHBCC-N099
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Feb 2026 (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.
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. This study aims to investigate the efficacy and safety of Famitinib combination with SHR-A1811 in CDK4/6 inhibitors-resistent advanced HR+/HER2- breast cancer with SNF4 subtype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: SHR-A1811SHR-A1811 |
| Experimental | Experimental | Drug: Famitinib+SHR-A1811Famitinib+SHR-A1811 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged 18-70 years old;
- Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER >10% of tumor cells positive by immunohistochemistry is defined as ER positive, PR >10% of tumor cells positive by immunohistochemistry is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 low expression or ultra-low expression [FISH/CISH- and IHC+/++ or IHC 0 but with ≤10% of tumor cells showing incomplete and weak cell membrane staining]);
- SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections and artificial intelligence;
- Locally advanced breast cancer (unresectable locally) or recurrent and metastatic breast cancer;
- Have used CDK4/6 inhibitors in the recurrent and metastatic stage, or have relapsed and metastasized within 1 year of adjuvant CDK4/6 inhibitor use;
Key exclusion criteria (20 listed)
- Uncontrolled central nervous system metastasis (referring to symptoms or the need for corticosteroids or mannitol to control symptoms);
- Left ventricular ejection fraction (LVEF) <50% (as determined by echocardiography);
- History of any of the following cardiac diseases: (1) angina pectoris; (2) clinically significant arrhythmia requiring medication; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease deemed unsuitable for participation in this trial by the investigator;
- previously suffered from clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or have been found to have suspected such diseases during screening period examinations;
- Individuals who have received radiotherapy, chemotherapy, surgical treatment (excluding minor outpatient surgeries such as placement of vascular access) or other targeted and immunotherapy treatments for advanced HR+/HER2- breast cancer within 3 weeks prior to the first administration of study drugs;
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 |
|---|---|---|
| SHR-A1811SHR-A1811 4.8mg/kg iv q3w | Drug | Control |
| Famitinib+SHR-A1811Famitinib 10mg po qd SHR-A1811 4.8mg/kg iv q3w | Drug | Experimental |
Primary outcome
Progression Free Survival(PFS) Based on Investigator Assessment
Time frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
6 secondary outcomes
Overall survival (OS)
Time frame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Objective response rate (ORR)
Time frame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Clinical benefit rate(CBR)
Time frame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Duration of Response(DOR)
Time frame: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Time to Response(TTR)
Time frame: from randomization to the achievement of first objective response, up to approximately 3 years
Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(TESAEs)
Time frame: From first dose of study drug (Day 1) up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1811 and Famitinib+SHR-A1811 in people with Breast Cancer, run by Fudan University 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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 3 Feb 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.
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?
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 Zhimin Shao (+8808 +86-021-64175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) Based on Investigator Assessment (time frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years). 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 3 Feb 2026.