HER2-Negative Locally Advanced Breast CancerPhase 2NCT06908668
Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
A Phase 2 study testing Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy and Neoadjuvant Chemotherapy Combined with Immunotherapy in people with HER2-Negative Locally Advanced Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HER2-Negative Locally Advanced Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy and Neoadjuvant Chemotherapy Combined with Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 10 Sep 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 70 years old.
- Pathologically confirmed as invasive breast cancer, with immunohistochemical staining indicating HER2 negativity, as specifically referenced in the guidelines of the American Society of Clinical
- Oncology/College of American Pathologists (ASCO/CAP).
- Clinical stage II-III, patients who are planned to undergo neoadjuvant treatment to downstage for surgery or who wish to have breast-conserving surgery after neoadjuvant treatment.
- The breast tumor is suitable for SBRT (stereotactic body radiotherapy) (tumor distance from the skin > 5 mm, without invasion of the ribs or intercostal muscles).
- No distant metastasis detected by clinical examination combined with imaging studies (including but not limited to liver ultrasound, chest CT, bone scan, PET-CT).
Show all 10Show fewer
- Adequate organ function (hemoglobin ≥ 100 g/L, white blood cells ≥ 3×10⁹/L, neutrophils ≥ 1.5×10⁹/L, platelets ≥ 80×10⁹/L; creatinine ≤ 132 μmol/L; alanine aminotransferase/aspartate aminotransferase ≤ 2.5×upper normal limit [UNL]).
- Capable of undergoing breast magnetic resonance imaging (MRI) scans. Eligible for follow-up conditions.
- The subject is able to sign the informed consent form to participate in the study.
- Women of childbearing age are not pregnant, not breastfeeding, and are using effective contraception.
Who cannot join
- Prior receipt of chest radiotherapy, chemotherapy, or immunotherapy.
- History of other malignancies, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid cancer.
- Patients with active fibroconnective tissue diseases, risk of active autoimmune diseases, or a history of autoimmune diseases that may involve the central nervous system, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, and autoimmune neuropathies (e.g., Guillain-Barré syndrome). The following exceptions apply: Type I diabetes mellitus, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic therapy, and autoimmune diseases caused by B cells or anti-self-antigen antibodies.
- Pulmonary disease defined as ≥ Grade 3 according to the NCI-CTCAE v5.0; history of interstitial lung disease (ILD) requiring corticosteroid treatment (including pulmonary fibrosis or radiation pneumonitis), or current ILD or ≥ Grade 2 radiation pneumonitis.
- Severe comorbidities or active diseases:
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: i. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or third-degree atrioventricular block; ii. QT interval prolongation at rest (QTc > 450 msec in males or > 470 msec in females); iii. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to the first dose; iv. Presence of heart failure with New York Heart Association (NYHA) functional class ≥ II.
Show all 12Show fewer
- Poorly controlled diabetes for > 1 month: fasting blood glucose > 10 mmol/L, or postprandial 2-hour blood glucose > 13 mmol/L.
- Poorly controlled psychiatric disorders with an episode or exacerbation within the past 6 months.
- Active infection. e) Positive for human immunodeficiency virus (HIV) antibodies. Other diseases that are not suitable for immunotherapy, or a history of other malignancies.
- Presence of severe internal medical conditions that may affect radiotherapy or immunotherapy.
- Pregnant or breastfeeding women.
- History of allergy to components of radiotherapy or immunotherapy.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Ma, 13910217780
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
- Being tested
- Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy, Neoadjuvant Chemotherapy Combined with Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy Combined with Immunotherapy and RadiotherapyDrug
- Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles.
- Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration).
- Radiotherapy:
Preoperative Radiotherapy:
Positioning: Immobilization with a neck-chest integrated frame, combined CT and MRI positioning with image fusion. Diagnostic MRI images can also be fused simultaneously. CT positioning should be performed with a plain scan, with a slice thickness of 3 mm. MRI positioning should include at least three sequences: T1-enhanced, T2 fat-suppressed, and DWI.
Target and Normal Organ Contouring:
GTVp (Gross Tumor Volume - Primary): Define the breast tumor target area based on MRI, CT, physical examination, and ultrasound
Neoadjuvant Chemotherapy Combined with ImmunotherapyDrug
- Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles.
- Recommended Immunotherapy Dose:
Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration).
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy | Experimental | 1. Recommended Chemotherapy Regimen and Doses:
Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles.
2. Recommended Immunotherapy Dose:
Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration).
3. Radiotherapy:
Preoperative Radiotherapy:
Positioning: Immobilization with a neck-chest integrated frame, combined CT and MRI positioning with image fusion. Diagnostic MRI images can also be fused simultaneously. CT positioning should be performed with a plain scan, with a slice thickness of 3 mm. MRI positioning should include at least three sequences: T1-enhanced, T2 fat-suppressed, and DWI.
Target and Normal Organ Contouring:
GTVp (Gross Tumor Volume - Primary): Define the breast tumor target area based on MRI, CT, physical examination, and ultrasoun Receives: Drug: Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy |
| Neoadjuvant Chemotherapy Combined with Immunotherapy | Active comparator | 1. Recommended Chemotherapy Regimen and Doses:
Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles.
2. Recommended Immunotherapy Dose:
Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). Receives: Drug: Neoadjuvant Chemotherapy Combined with Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
For binary efficacy endpoints (including pCR, ORR, etc.), the number of subjects and percentage in each category will be summarized, and the 95% confidence interval for the rate will be calculated using the Clopper-Pearson method.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start31 Mar 2025
- Primary completion10 Sep 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Negative Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908668
- Sponsor's protocol ID
- NCC5177
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06908668
- Acronym / sponsor ID
- NCC5177
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 3 Apr 2025 (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.
A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy | Experimental | Drug: Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). 3. Radiotherapy: Preoperative Radiotherapy: Positioning: Immobilization with a neck-chest integrated frame, combined CT and MRI positioning with image fusion. Diagnostic MRI images can also be fused simultaneously. CT positioning should be performed with a plain scan, with a slice thickness of 3 mm. MRI positioning should include at least three sequences: T1-enhanced, T2 fat-suppressed, and DWI. Target and Normal Organ Contouring: GTVp (Gross Tumor Volume - Primary): Define the breast tumor target area based on MRI, CT, physical examination, and ultrasoun |
| Neoadjuvant Chemotherapy Combined with Immunotherapy | Active comparator | Drug: Neoadjuvant Chemotherapy Combined with Immunotherapy1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged between 18 and 70 years old.
- Pathologically confirmed as invasive breast cancer, with immunohistochemical staining indicating HER2 negativity, as specifically referenced in the guidelines of the American Society of Clinical
- Oncology/College of American Pathologists (ASCO/CAP).
- Clinical stage II-III, patients who are planned to undergo neoadjuvant treatment to downstage for surgery or who wish to have breast-conserving surgery after neoadjuvant treatment.
- The breast tumor is suitable for SBRT (stereotactic body radiotherapy) (tumor distance from the skin > 5 mm, without invasion of the ribs or intercostal muscles).
Key exclusion criteria (12 listed)
- Prior receipt of chest radiotherapy, chemotherapy, or immunotherapy.
- History of other malignancies, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid cancer.
- Patients with active fibroconnective tissue diseases, risk of active autoimmune diseases, or a history of autoimmune diseases that may involve the central nervous system, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, and autoimmune neuropathies (e.g., Guillain-Barré syndrome). The following exceptions apply: Type I diabetes mellitus, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic therapy, and autoimmune diseases caused by B cells or anti-self-antigen antibodies.
- Pulmonary disease defined as ≥ Grade 3 according to the NCI-CTCAE v5.0; history of interstitial lung disease (ILD) requiring corticosteroid treatment (including pulmonary fibrosis or radiation pneumonitis), or current ILD or ≥ Grade 2 radiation pneumonitis.
- Severe comorbidities or active diseases:
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 |
|---|---|---|
| Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). 3. Radiotherapy: Preoperative Radiotherapy: Positioning: Immobilization with a neck-chest integrated frame, combined CT and MRI positioning with image fusion. Diagnostic MRI images can also be fused simultaneously. CT positioning should be performed with a plain scan, with a slice thickness of 3 mm. MRI positioning should include at least three sequences: T1-enhanced, T2 fat-suppressed, and DWI. Target and Normal Organ Contouring: GTVp (Gross Tumor Volume - Primary): Define the breast tumor target area based on MRI, CT, physical examination, and ultrasound | Drug | Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy |
| Neoadjuvant Chemotherapy Combined with Immunotherapy1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). | Drug | Neoadjuvant Chemotherapy Combined with Immunotherapy |
Primary outcome
Pathological Complete Response (pCR)
Time frame: 24 months
For binary efficacy endpoints (including pCR, ORR, etc.), the number of subjects and percentage in each category will be summarized, and the 95% confidence interval for the rate will be calculated using the Clopper-Pearson method.
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 10 Jun 2026.
Related trials for HER2-Negative Locally Advanced Breast Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Breast Cancer
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 Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy and Neoadjuvant Chemotherapy Combined with Immunotherapy in people with HER2-Negative Locally Advanced 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 10 inclusion and 12 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 10 Jun 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 Fei Ma (13910217780, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: 24 months). 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 10 Jun 2026.