Breast CancerPhase 2NCT06149130
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
A Phase 2 study testing Adebrelimab and dalpiciclib in people with Breast Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter Phase II study of patients with advanced HR+/HER2- breast cancer who are untreated or have failed previous first-line endocrine therapy。The primary objective of this study was to explore the efficacy and safety of the PD-L1 inhibitor adebrelimab in combination with the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adebrelimab and dalpiciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to 30 Nov 2026
- Phase
- Phase 2
- 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
- Premenopausal/perimenopausal or postmenopausal women aged ≥18 years and ≤75 years;
- Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER >10% tumor cell positive is defined as ER positive, PR >10% tumor cell positive is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
- Locally advanced breast cancer (radical local treatment is not possible) or recurrent metastatic breast cancer;
- Did not receive any systemic anti-cancer therapy at the stage of recurrence and metastasis or failed to receive first-line endocrine therapy at the advanced stage;
- Allowed to receive ≤1 line of chemotherapy
- Have at least one measurable lesion according to RECIST version 1.1
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- Adequate hematology and organ function, including:
- hemoglobin > 9 g/dL without blood transfusion or erythropoietin in the past 14 days.
- ANC ≥ 1.5×109/L without using granulocyte colony stimulating factor in the past 14 days.
- PLT ≥ 75×109/L without blood transfusion in the past 14 days. TBIL ≤ 1.5 ×ULN (Gilbert syndrome allows ≤ 3 × ULN). ALT and AST ≤ 3 × ULN (if there is liver metastasis, ALT and AST ≤ 5 × ULN). Serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
- ECOG score 0 or 1, and life expectancy ≥3 months;
- Fertile female subjects are required to use a medically approved contraceptive during the study treatment period and for at least 3 months after the last use of the study drug;
- Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Previous use of CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibody
- Uncontrolled central nervous system metastasis (meaning symptoms or the use of glucocorticoids or mannitol to control symptoms);
- 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, surgery, or other targeted and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of the study drug;
- Pregnant or lactating patients;
- Malignant tumors within the past three years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
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- Significant comorbidities, including mental illnesses that the investigator believes will adversely affect the patient's participation in the study;
- Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug;
- Patients with known HBV or HCV infection active phase or HBV DNA≥500, or chronic phase with abnormal liver function;
- History of active autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
- A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia;
- Patients with active infection or who had been treated with systemic immune stimulating factors within 4 weeks prior to enrollment;
- Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
- Previous thyroid dysfunction;
- The investigator did not consider the patient suitable for participation in any other conditions of the 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, 1 recruiting
- Recruiting
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Huihua Xiong, PI, 027-83663405, xionghuihua@hotmail.com
Huihua Xiong, PI
About this study
Official title: Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer:a Single-arm, Phase II Exploratory Clinical Study
This is a prospective, single-arm, multicenter Phase II study of patients with advanced HR+/HER2- breast cancer who are untreated or have failed previous first-line endocrine therapy。The primary objective of this study was to explore the efficacy and safety of the PD-L1 inhibitor adebrelimab in combination with the CDK4/6 inhibitor Dalpiciclib and standard endocrine therapy in advanced HR+/ HER2-breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Adebrelimab, dalpiciclib
- Keywords
- HR+/HER2- breast cancer, adebrelimab, dalpiciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
adebrelimab:1200mg intravenously, Q3W.
dalpiciclibDrug
Also called SHR-6390
dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 1. Adebrelimab: 1200mg intravenously ,Q3W
2. dalpiciclib : 150mg once a day for 3 weeks, stop for 1 week, Q4W
3. Endocrine recommended drugs untreated: aromatase inhibitors (letrozole/anastrozole/exemestane), given orally once daily at a specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, exemestane 25mg/ day); first-line endocrine therapy failed: fluvestrant was given once every 28 days, 500mg intramuscular injection, and then 500mg intramuscular injection 2 weeks after the first administration; Receives: Drug: Adebrelimab; Drug: dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.
Measured: Up to 3 years
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.
Measured: Up to 3 years
Overall survival (OS)
OS is defined as the time between enrollment and the patient's death due to any OS is defined as the time between enrollment and the patient's death due to any cause
Measured: Up to 5 years
Incidence of Treatment-Emergent Adverse Events
Includes the Treatment-Emergent adverse event profile and rates according to the Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start11 Jan 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (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 Tongji HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huihua Xiong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149130
- Sponsor's protocol ID
- TJ-IRB20231105
- Status last verified
- Apr 2024
- First submitted
- 20 Nov 2023
- Last updated
- 15 Apr 2024
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer:a Single-arm, Phase II Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06149130
- Acronym / sponsor ID
- TJ-IRB20231105
- Conditions
- Breast Cancer
- Keywords
- HR+/HER2- breast cancer, adebrelimab, dalpiciclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 28 Nov 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.
This is a prospective, single-arm, multicenter Phase II study of patients with advanced HR+/HER2- breast cancer who are untreated or have failed previous first-line endocrine therapy。The primary objective of this study was to explore the efficacy and safety of the PD-L1 inhibitor adebrelimab in combination with the CDK4/6 inhibitor Dalpiciclib and standard endocrine therapy in advanced HR+/ HER2-breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Adebrelimab, Drug: dalpiciclib1. Adebrelimab: 1200mg intravenously ,Q3W 2. dalpiciclib : 150mg once a day for 3 weeks, stop for 1 week, Q4W 3. Endocrine recommended drugs untreated: aromatase inhibitors (letrozole/anastrozole/exemestane), given orally once daily at a specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, exemestane 25mg/ day); first-line endocrine therapy failed: fluvestrant was given once every 28 days, 500mg intramuscular injection, and then 500mg intramuscular injection 2 weeks after the first administration; |
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)
- Premenopausal/perimenopausal or postmenopausal women aged ≥18 years and ≤75 years;
- Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER >10% tumor cell positive is defined as ER positive, PR >10% tumor cell positive is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
- Locally advanced breast cancer (radical local treatment is not possible) or recurrent metastatic breast cancer;
- Did not receive any systemic anti-cancer therapy at the stage of recurrence and metastasis or failed to receive first-line endocrine therapy at the advanced stage;
- Allowed to receive ≤1 line of chemotherapy
Key exclusion criteria (15 listed)
- Previous use of CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibody
- Uncontrolled central nervous system metastasis (meaning symptoms or the use of glucocorticoids or mannitol to control symptoms);
- 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, surgery, or other targeted and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of the study drug;
- Pregnant or lactating patients;
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 |
|---|---|---|
| AdebrelimabAlso: SHR-1316adebrelimab:1200mg intravenously, Q3W. | Drug | treatment group |
| dalpiciclibAlso: SHR-6390dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W. | Drug | treatment group |
Primary outcome
Progression-free survival(PFS)
Time frame: Up to 3 years
PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.
3 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 5 years
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 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 15 Apr 2024.
- 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 2 study testing Adebrelimab and dalpiciclib in people with Breast Cancer, run by Tongji Hospital 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 15 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 15 Apr 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiong huihua (027-83663405, xionghuihua@hotmail.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) (time frame: Up to 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 15 Apr 2024.