HR+HER2- Breast CancerPhase 2NCT06639672
Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer
A Phase 2 study testing Chemotherapy+PD-1 inhibitor+8Gy x 3f, Chemotherapy+PD-1 inhibitor+16Gy x 1f and Chemotherapy+PD-1 inhibitor+2.67Gy x 15f in people with HR+HER2- Breast Cancer, run by Lei Liu.
Trial summary
For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HR+HER2- Breast Cancer
- What is being tested?
- Chemotherapy+PD-1 inhibitor+8Gy x 3f, Chemotherapy+PD-1 inhibitor+16Gy x 1f and Chemotherapy+PD-1 inhibitor+2.67Gy x 15f
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 May 2031
- 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
- 1. Histologically or cytologically confirmed HR+/HER2- breast cancer
- 2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）
- 3. ECOG performance status of 0-1;
- 4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;
- 5. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;
- 6. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;
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- 7. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area;
- 8. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);
- 9. No severe organic heart disease or arrhythmias;
- 10. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;
- 11. Voluntary signed informed consent by the study participant.
Who cannot join
- 1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.
- 2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.
- 3. Poorly controlled tumor-related pain.
- 4. Patients participating in other clinical studies simultaneously.
- 5. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
- 6. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.
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- 7. Active pulmonary tuberculosis.
- 8. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.
- 9. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.
- 10. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death , such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.
- 11. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.
- 12. Patients who have previously received allogeneic stem cell or solid organ transplants.
- 13. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer: A Phase II Study
For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+/HER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+/HER2- breast cancer.
- Conditions
- HR+HER2- Breast Cancer
- Being tested
- Chemotherapy+PD-1 inhibitor+8Gy x 3f, Chemotherapy+PD-1 inhibitor+16Gy x 1f, Chemotherapy+PD-1 inhibitor+2.67Gy x 15f, Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f
- Keywords
- HR+/HER2- breast cancer, Neoadjuvant chemotherapy, Immunotherapy, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy+PD-1 inhibitor+8Gy x 3fDrug
Radiotherapy: 8Gy x 3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+16Gy x 1fDrug
Radiotherapy: 16Gy x 1f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+2.67Gy x 15fDrug
Radiotherapy: 2.67Gy x 15f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18fDrug
Radiotherapy: 0.5Gy x 12-18f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 8Gy x 3f + Chemotherapy+Immunotherapy Receives: Drug: Chemotherapy+PD-1 inhibitor+8Gy x 3f |
| Arm 2 | Experimental | 16Gy x 1f + Chemotherapy+Immunotherapy Receives: Drug: Chemotherapy+PD-1 inhibitor+16Gy x 1f |
| Arm 3 | Experimental | 2.76Gy x 15f + Chemotherapy+Immunotherapy Receives: Drug: Chemotherapy+PD-1 inhibitor+2.67Gy x 15f |
| Arm 4 | Experimental | 0.5Gy x 12-18f + Chemotherapy+Immunotherapy Receives: Drug: Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
The percentage of patients showing no evidence of invasive cancer cells in the tissue samples after treatment
Measured: Up to approximately 2 years
Secondary outcomes (4)
Ipsilateral breast recurrence or local regional recurrence
The percentage of patients experiencing a recurrence of cancer in the same breast or in the nearby lymph nodes
Measured: 5 year
Overall survival
The time from the start of treatment until the occurrence of death
Measured: 5 year
Distant metastasis-free survival
the time from the start of treatment until the occurrence of distant metastasis
Measured: 5 year
Incidence of Treatment-Emergent Adverse Events
the incidence of adverse events
Measured: Up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HR+HER2- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639672
- Sponsor's protocol ID
- 20241777
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan J, Sun X, Huang X, Zhao Y, Bi Z, Huang W, Luo T, Jing J, Wu X, Liu L. A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer. Front Immunol. 2026 Jul 9;17:1836220. doi: 10.3389/fimmu.2026.1836220. eCollection 2026.
PubMed 42495649
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT06639672
- Acronym / sponsor ID
- 20241777
- Conditions
- HR+HER2- Breast Cancer
- Keywords
- HR+/HER2- breast cancer, Neoadjuvant chemotherapy, Immunotherapy, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lei LiuUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 15 Oct 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.
For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+/HER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Chemotherapy+PD-1 inhibitor+8Gy x 3f8Gy x 3f + Chemotherapy+Immunotherapy |
| Arm 2 | Experimental | Drug: Chemotherapy+PD-1 inhibitor+16Gy x 1f16Gy x 1f + Chemotherapy+Immunotherapy |
| Arm 3 | Experimental | Drug: Chemotherapy+PD-1 inhibitor+2.67Gy x 15f2.76Gy x 15f + Chemotherapy+Immunotherapy |
| Arm 4 | Experimental | Drug: Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f0.5Gy x 12-18f + Chemotherapy+Immunotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Histologically or cytologically confirmed HR+/HER2- breast cancer
- 2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）
- 3. ECOG performance status of 0-1;
- 4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;
- 5. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;
Key exclusion criteria (13 listed)
- 1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.
- 2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.
- 3. Poorly controlled tumor-related pain.
- 4. Patients participating in other clinical studies simultaneously.
- 5. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
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 |
|---|---|---|
| Chemotherapy+PD-1 inhibitor+8Gy x 3fRadiotherapy: 8Gy x 3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks | Drug | Arm 1 |
| Chemotherapy+PD-1 inhibitor+16Gy x 1fRadiotherapy: 16Gy x 1f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks | Drug | Arm 2 |
| Chemotherapy+PD-1 inhibitor+2.67Gy x 15fRadiotherapy: 2.67Gy x 15f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks | Drug | Arm 3 |
| Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18fRadiotherapy: 0.5Gy x 12-18f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks | Drug | Arm 4 |
Primary outcome
pCR
Time frame: Up to approximately 2 years
The percentage of patients showing no evidence of invasive cancer cells in the tissue samples after treatment
4 secondary outcomes
Ipsilateral breast recurrence or local regional recurrence
Time frame: 5 year
Overall survival
Time frame: 5 year
Distant metastasis-free survival
Time frame: 5 year
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to approximately 1 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 Oct 2024.
- Derived from this study: PubMed 42495649Lan J, Sun X, Huang X, Zhao Y, Bi Z, Huang W, Luo T, Jing J, Wu X, Liu L. A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer. Front Immunol. 2026 Jul 9;17:1836220. doi: 10.3389/fimmu.2026.1836220. eCollection 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy+PD-1 inhibitor+8Gy x 3f, Chemotherapy+PD-1 inhibitor+16Gy x 1f and Chemotherapy+PD-1 inhibitor+2.67Gy x 15f in people with HR+HER2- Breast Cancer, run by Lei Liu.
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 11 inclusion and 13 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Wang, MD (18805053037, 13882713780@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639672, which also lists 1 linked publication.
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 Oct 2024.