Advanced Breast CancerPhase 3NCT06447623
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
A Phase 3 study testing Apatinib, CDK4/6 Inhibitor and Aromatase inhibitor and Fulvestrant in people with Advanced Breast Cancer and HR+/HER2- Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer, HR+/HER2- Breast Cancer
- What is being tested?
- Apatinib, CDK4/6 Inhibitor and Aromatase inhibitor and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 1 Feb 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients need to meet all of the following conditions
- Patients must be ≥18 and ≤ 75 years of age;
- Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER \>10%, or/and PR\>10%, HER 0 OR +, if HER2++, FISH negative);
- SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections;
- Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended);
- No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
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- Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;
- The functions of the main organs are basically normal, and the following conditions are met:
- Blood routine examination standards should meet: HB≥90g/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 ≤1.5×ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula);
- ECOG performance status 0 or 1; The expected survival is more than 3 months;
- Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
- Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
Who cannot join
- Patients with any of the following conditions were excluded from the study
- Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
- Pregnant or lactating patients;
- Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;
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- Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\'s participation in the study;
- Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
- The investigator does not consider the patient suitable for participation in any other circumstances of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
- Conditions
- Advanced Breast Cancer, HR+/HER2- Breast Cancer
- Being tested
- Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant
- Keywords
- HR+/HER2- breast cancer, Advanced Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib is a kind of TKI inhibitor.
CDK4/6 InhibitorDrug
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Aromatase inhibitor and FulvestrantDrug
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | Apatinib combined with cdk4/6i and Endocrine therapy. Receives: Drug: Apatinib; Drug: CDK4/6 Inhibitor; Drug: Aromatase inhibitor and Fulvestrant |
| Arm-B | Active comparator | cdk4/6i and Endocrine therapy. Receives: Drug: CDK4/6 Inhibitor; Drug: Aromatase inhibitor and Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
Measured: Approximately 5 years
Secondary outcomes (4)
Clinical Benefit Rate (CBR)
CBR is the total percentage of participants who achieved a complete response, partial response, or had stable disease for 6 months or more.
Measured: Approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Measured: Approximately 5 years
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Approximately 5 years
Safety and tolerability
Number of adverse events according to NCI-CTCAE Version 5.0 per each treatment arm.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start11 Jun 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 184 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
- NCT06447623
- Sponsor's protocol ID
- SCHBCC-N068
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2024
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
- ClinicalTrials.gov ID
- NCT06447623
- Acronym / sponsor ID
- SCHBCC-N068
- Conditions
- Advanced Breast Cancer, HR+/HER2- Breast Cancer
- Keywords
- HR+/HER2- breast cancer, Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 7 Jun 2024 (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 is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Drug: Apatinib, Drug: CDK4/6 Inhibitor, Drug: Aromatase inhibitor and FulvestrantApatinib combined with cdk4/6i and Endocrine therapy. |
| Arm-B | Active comparator | Drug: CDK4/6 Inhibitor, Drug: Aromatase inhibitor and Fulvestrantcdk4/6i and Endocrine therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients need to meet all of the following conditions
Key exclusion criteria (9 listed)
- Patients with any of the following conditions were excluded from the study
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 |
|---|---|---|
| ApatinibApatinib is a kind of TKI inhibitor. | Drug | Arm-A |
| CDK4/6 InhibitorDalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer. | Drug | Arm-A, Arm-B |
| Aromatase inhibitor and FulvestrantEndocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin. | Drug | Arm-A, Arm-B |
Primary outcome
Progression Free Survival (PFS)
Time frame: Approximately 5 years
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
4 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: Approximately 5 years
Objective Response Rate (ORR)
Time frame: Approximately 5 years
Overall Survival (OS)
Time frame: Approximately 5 years
Safety and tolerability
Time frame: Approximately 5 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 25 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Apatinib, CDK4/6 Inhibitor and Aromatase inhibitor and Fulvestrant in people with Advanced Breast Cancer and HR+/HER2- 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 13 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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?
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?
Progression Free Survival (PFS) (time frame: Approximately 5 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 25 Sep 2026.