Breast CancerPhase 2NCT06500208
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
A Phase 2 study testing Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \> 20%;
- IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
- At least one measurable lesion according to RECIST 1.1;
- Available core needle biopsy samples for PD-L1 status testing;
- ECOG 0 or 1 within 10 days prior to initiation of treatment;
- Not currently pregnant or breastfeeding, agree to strict contraception during treatment and at least 6 months after last dose;
- Intact hematologic, liver, renal and heart functions;
- Signed written informed consent.
Who cannot join
- Bilateral invasive breast cancer or Stage IV breast cancer;
- Severe heart disease;
- Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment;
- Had active autoimmune diseases requiring systemic therapy within the past 2 years;
- Severe systemic infections or other serious medical conditions;
- Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
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- History of HIV infection;
- Active HBV or HCV infection;
- Known allergies or intolerance to the therapeutic drug or its excipients;
- History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors;
- Judged by the investigator to be unsuitable to participate 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, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Haoyu Wang, 86 021-64370045, meredithwhy@163.com
Xiaosong Chen, chenxiaosong0156@hotmail.com
About this study
Official title: An Open-label, One-arm Phase II Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for High-risk, Early-stage and Locally Advanced Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer.
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
- Conditions
- Breast Cancer
- Being tested
- Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
- Keywords
- breast cancer, ER+/HER2-, neoadjuvant, Adebrelimab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamideDrug
Adebrelimab 1200mg i.v. q3w combined with nab-paclitaxel 100mg/m2 qw*12w followed by epirubicin 90mg/m2 and cyclophosphamide 600mg/m2 q3w for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab and chemotherapy | Experimental | Adebrelimab 1200 mg Q3W combined with nab-paclitaxel (100 mg/m2 Q1W) for 4 cycles followed by epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) Q3W for 4 cycles. Receives: Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes
Measured: up to 8 months, after patients complete surgery
Secondary outcomes (3)
ORR
Objective Response Rate: patients achieving partial response and complete response during treatment
Measured: up to 8 months, after patients complete surgery
Incidence of adverse events (Safety)
adverse events of patients receiving at least one cycle of treatment
Measured: up to 8 months, after patients complete surgery
pCR rate in PD-L1 CPS≥1 subgroup
pathological complete response rate in patients with PD-L1 CPS score ≥1
Measured: up to 8 months, after patients complete surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500208
- Sponsor's protocol ID
- RJBC-2402
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-arm Phase II Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for High-risk, Early-stage and Locally Advanced Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer.
- ClinicalTrials.gov ID
- NCT06500208
- Acronym / sponsor ID
- RJBC-2402
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ER+/HER2-, neoadjuvant, Adebrelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 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.
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab and chemotherapy | Experimental | Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamideAdebrelimab 1200 mg Q3W combined with nab-paclitaxel (100 mg/m2 Q1W) for 4 cycles followed by epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) Q3W for 4 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \> 20%;
- IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
- At least one measurable lesion according to RECIST 1.1;
- Available core needle biopsy samples for PD-L1 status testing;
- ECOG 0 or 1 within 10 days prior to initiation of treatment;
Key exclusion criteria (11 listed)
- Bilateral invasive breast cancer or Stage IV breast cancer;
- Severe heart disease;
- Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment;
- Had active autoimmune diseases requiring systemic therapy within the past 2 years;
- Severe systemic infections or other serious medical conditions;
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 |
|---|---|---|
| Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamideAdebrelimab 1200mg i.v. q3w combined with nab-paclitaxel 100mg/m2 qw*12w followed by epirubicin 90mg/m2 and cyclophosphamide 600mg/m2 q3w for 4 cycles | Drug | Adebrelimab and chemotherapy |
Primary outcome
pCR rate
Time frame: up to 8 months, after patients complete surgery
pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes
3 secondary outcomes
ORR
Time frame: up to 8 months, after patients complete surgery
Incidence of adverse events (Safety)
Time frame: up to 8 months, after patients complete surgery
pCR rate in PD-L1 CPS≥1 subgroup
Time frame: up to 8 months, after patients complete surgery
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 26 Jun 2025.
- 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.
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 combined with nab-paclitaxel, epirubicin and cyclophosphamide in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 8 inclusion and 11 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 26 Jun 2025. 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 Haoyu Wang (86 021-64370045, meredithwhy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: up to 8 months, after patients complete surgery). 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 26 Jun 2025.