Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 2NCT07317778
Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer
A Phase 2 study testing SHR-A1811, Adebrelimab (PD-L1 inhibitor) and Taxane Chemotherapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and HR Positive/HER2 Low Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer
- What is being tested?
- SHR-A1811, Adebrelimab (PD-L1 inhibitor) and Taxane Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 15 Sep 2033
- 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
- ECOG score: 0-1;
- Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;
- HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative);
- Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;
- Sufficient organ function
- Female patients who have not undergone menopause or sterilization, accept for abstain from sexual activity or use an effective contraceptive method during the treatment period and at least 7 months after the last administration of the study medication;
- Voluntarily participate and sign the informed consent form.
Who cannot join
- Inflammatory breast cancer;
- Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);
- Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;
- Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period;
- Had any cardiac diseases, including: (1) Severe / unstable angina pectoris; (2) Requires drug treatment or has clinically significant arrhythmia; (3) Had a myocardial infarction within 6 months before enrollment; (4) Has symptomatic congestive heart failure with NYHA grade ≥ II; (5) Any other heart diseases judged by the researcher as not suitable for participation in this trial;
- Known to have had an allergic history to the components of the drug in this protocol; have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- Had severe comorbidities or other conditions that would interfere with the planned treatment, or any other situation that the researcher considered the patient was not suitable 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
National Cancer Center/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
About this study
Official title: Chemotherapy Combine With or Without Adebrelimab and Trastuzumab Rezetecan(SHR-A1811) as Neoadjuvant Therapy for Hormone Receptor Positive/HER2 Low Early Stage Breast Cancer: A Randomized Phase II Trial
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are:
Is Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+/HER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and/or Adebrelimab plus chemotherapy
Read more
Participants will:
Take 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1).
Visit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.
- Being tested
- SHR-A1811, Adebrelimab (PD-L1 inhibitor), Taxane Chemotherapy, Anthracycline & Cyclophosphamide treatment scheme
- Keywords
- SHR-A1811, adebrelimab, Trastuzumab Rezetecan, HR+/HER2-low, early stage breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Also called Trastuzumab Rezetecan, T-DXh
An anti-HER2 ADC injection, administered on day 1 of each cycle, with one cycle every 3 weeks. 4.8mg/kg or 5.6mg/kg IV, according to the outcomes of the safety run in process.
Adebrelimab (PD-L1 inhibitor)Drug
Also called SHR-A1316
A PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle.
Taxane ChemotherapyDrug
Could be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice.
Anthracycline & Cyclophosphamide treatment schemeDrug
Anthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: SHR-A1811-EC + Adebrelimab | Experimental | 4 cycles of SHR-A1811 follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. Receives: Drug: SHR-A1811; Drug: Adebrelimab (PD-L1 inhibitor); Drug: Anthracycline & Cyclophosphamide treatment scheme |
| Arm 2: T-EC + Adebrelimab | Experimental | 4 cycles of taxane follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. Receives: Drug: Adebrelimab (PD-L1 inhibitor); Drug: Taxane Chemotherapy; Drug: Anthracycline & Cyclophosphamide treatment scheme |
| Arm 3: T-EC | Active comparator | 4 cycles of taxane follow by 4 cycles of EC chemotherapy Receives: Drug: Taxane Chemotherapy; Drug: Anthracycline & Cyclophosphamide treatment scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR(ypT0/Tis ypN0M0)
total pathological complete response, define as ypT0/Tis ypN0 M0 assessed according to the AJCC staging criteria
Measured: After surgery (within 1 month)
Secondary outcomes (3)
EFS
event free survival, defined as the time from randomization to disease progression that precluded surgery, local or distant recurrence, second primary cancer or death due to any cause, whichever occurred first.
Measured: from enrollment to completion of 3 years of follow up after surgery
OS
overall survival, define as the time from randomization to death due to any cause.
Measured: from enrollment to complete of 5 years follow up after surgery
Adverse Events
The safety assessment includes the categories and incidence rates of adverse events, as well as the severity grade according to CTCAE 6.0
Measured: AEs were assessed from enrollment throughout the trial and for 30 days after discontinuation of treatment (90 days for serious AEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YING FAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317778
- Sponsor's protocol ID
- MA-BC-II-094
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Combine With or Without Adebrelimab and Trastuzumab Rezetecan(SHR-A1811) as Neoadjuvant Therapy for Hormone Receptor Positive/HER2 Low Early Stage Breast Cancer: A Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT07317778
- Acronym / sponsor ID
- MA-BC-II-094
- Keywords
- SHR-A1811, adebrelimab, Trastuzumab Rezetecan, HR+/HER2-low, early stage breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Sep 2033 (estimated)
- First posted
- 5 Jan 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.
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are:
Is Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+/HER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and/or Adebrelimab plus chemotherapy
Participants will:
Take 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1).
Visit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: SHR-A1811-EC + Adebrelimab | Experimental | Drug: SHR-A1811, Drug: Adebrelimab (PD-L1 inhibitor), Drug: Anthracycline & Cyclophosphamide treatment scheme4 cycles of SHR-A1811 follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. |
| Arm 2: T-EC + Adebrelimab | Experimental | Drug: Adebrelimab (PD-L1 inhibitor), Drug: Taxane Chemotherapy, Drug: Anthracycline & Cyclophosphamide treatment scheme4 cycles of taxane follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. |
| Arm 3: T-EC | Active comparator | Drug: Taxane Chemotherapy, Drug: Anthracycline & Cyclophosphamide treatment scheme4 cycles of taxane follow by 4 cycles of EC chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG score: 0-1;
- Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;
- HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative);
- Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;
- Sufficient organ function
Key exclusion criteria (8 listed)
- Inflammatory breast cancer;
- Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);
- Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;
- Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period;
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-A1811Also: Trastuzumab Rezetecan, T-DXhAn anti-HER2 ADC injection, administered on day 1 of each cycle, with one cycle every 3 weeks. 4.8mg/kg or 5.6mg/kg IV, according to the outcomes of the safety run in process. | Drug | Arm 1: SHR-A1811-EC + Adebrelimab |
| Adebrelimab (PD-L1 inhibitor)Also: SHR-A1316A PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle. | Drug | Arm 1: SHR-A1811-EC + Adebrelimab, Arm 2: T-EC + Adebrelimab |
| Taxane ChemotherapyCould be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice. | Drug | Arm 2: T-EC + Adebrelimab, Arm 3: T-EC |
| Anthracycline & Cyclophosphamide treatment schemeAnthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle. | Drug | Arm 1: SHR-A1811-EC + Adebrelimab, Arm 2: T-EC + Adebrelimab, Arm 3: T-EC |
Primary outcome
tpCR(ypT0/Tis ypN0M0)
Time frame: After surgery (within 1 month)
total pathological complete response, define as ypT0/Tis ypN0 M0 assessed according to the AJCC staging criteria
3 secondary outcomes
EFS
Time frame: from enrollment to completion of 3 years of follow up after surgery
OS
Time frame: from enrollment to complete of 5 years follow up after surgery
Adverse Events
Time frame: AEs were assessed from enrollment throughout the trial and for 30 days after discontinuation of treatment (90 days for serious AEs)
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 5 Jan 2026.
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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 SHR-A1811, Adebrelimab (PD-L1 inhibitor) and Taxane Chemotherapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and HR Positive/HER2 Low Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 8 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 5 Jan 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 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 Yiqun Li (+86-010-87788120, Liyiqun_chcams@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR(ypT0/Tis ypN0M0) (time frame: After surgery (within 1 month)). 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 5 Jan 2026.