Breast AdenocarcinomaPhase 2NEOTRIO-HRNCT06671262
Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer
A Phase 2 study testing SBRT and Immuno-chemotherapy in people with Breast Adenocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are: Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Adenocarcinoma
- What is being tested?
- SBRT and Immuno-chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 1 Nov 2027
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk HR+/HER2-negative breast cancer is defined as ER≥1%, HER2-negative (<2+ Her2 IHC or <2.2 HER2/CEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;
- Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;
- The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)< 10%;
- ECOG score of 0-1;
- Screening laboratory values must meet the following criteria: i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
Who cannot join
- Inflammatory breast cancer
- Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);
- Clinically symptomatic heart disease;
- Previous systemic treatment or radiotherapy for breast cancer;
- Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;
- Radiotherapy contraindications: history of radiotherapy;
- Women shall not be breastfeeding.
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
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Ting Zhang, phD, +86-571-87783521, zezht@zju.edu.cn
About this study
Official title: Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer（NEOTRIO-HR）
The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are:
- Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？
- Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?
Read more
Participants will be randomly assigned to one of three treatment regimens:
- Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;
- Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;
- Preoperative toripalimab combined with chemotherapy alone.
Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.
The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.
Read the detailed description
Breast cancer is a leading malignancy among women globally, with early diagnosis and treatment being crucial for better outcomes. Over 90% of breast cancer patients are diagnosed at an early stage, and approximately two-thirds have the hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) subtype. Despite this, these patients often exhibit resistance to neoadjuvant chemotherapy, with a pathologic complete response (pCR) rate of only 5-15%, which is significantly lower compared to other subtypes and is associated with poor prognosis. This indicates the necessity for optimizing current treatment strategies.
In recent years, significant advancements have been made in the application of immunotherapy for breast cancer. The studies demonstrated that the addition of immune checkpoint inhibitors to neoadjuvant chemotherapy for patients with high-risk early-stage HR+/HER2- breast cancer significantly improved pCR rates.
Building on these findings, this study proposes a novel strategy of dose-intensified radiation to the tumor (tumor boost) during the neoadjuvant immuno-chemotherapy phase. The advantage of this approach is that it can activate the immune system while the tumor tissue is still intact, providing a rich source of tumor antigens, which aids in enhancing the immune system's recognition and destruction of cancer cells.
Toripalimab is an optimal immunotherapy agent to study, as this agent has recently been approved by the FDA for use in multiple tumor types. It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments. This study will provide valuable insights into the potential of immunotherapy in combination with radiotherapy to improve outcomes for patients with lymph nodes-positive, high-risk HR+/HER2- breast cancer.
- Conditions
- Breast Adenocarcinoma
- Being tested
- SBRT, Immuno-chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Target the primary tumor region with a single dose of 8Gy, or deliver a dose of 3Gy to the axillary lymph nodes, administered once a day for three consecutive days.
Immuno-chemotherapyDrug
Standard new adjuvant treatment with toripalimab combined with chemotherapy, that is in the first phase consisting of paclitaxel and toripalimab for four cycles, followed by epirubicin, cyclophosphamide, and toripalimab for another four cycles.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | Patients in this arm receive only a single injection of toripalimab without any radiotherapy as an initial treatment. After a three-week interval, patients receive the standard neoadjuvant chemotherapy in combination with toripalimab, starting with four cycles of paclitaxel and toripalimab, followed by four cycles of epirubicin and toripalimab. Receives: Drug: Immuno-chemotherapy |
| The SBRT-combined group 1 | Experimental | Patients enrolled in this treatment arm will undergo SBRT focused on the primary tumor, receiving a total dose of 24Gy divided into three fractions over the course of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days post-treatment. After a three-week rest period, patients will commence the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen will begin with four cycles of paclitaxel combined with toripalimab and followed by four cycles of epirubicin combined with toripalimab. Receives: Radiation: SBRT; Drug: Immuno-chemotherapy |
| The SBRT-combined group 2 | Experimental | In this treatment protocol, patients will receive a total radiation dose of 24Gy in three fractions, specifically targeting the primary tumor. Concurrently, the axillary lymph nodes will be treated with a dose of 9Gy in three fractions. This radiation therapy will be conducted over a period of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days after the completion of the radiation treatment. After a three-week interval, patients will proceed with the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen includes an initial phase of four cycles of paclitaxel paired with toripalimab, which will be followed by a subsequent phase of four cycles of epirubicin paired with toripalimab. Receives: Radiation: SBRT; Drug: Immuno-chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathological Complete Response (pCR) is characterized by the absence of any invasive residual primary tumor in both the breast and lymph nodes. The primary objective of this study is to compare the pCR rates between two treatment approaches: neoadjuvant toripalimab combined with SBRT followed by immuno-chemotherapy, and neoadjuvant toripalimab combined with chemotherapy.
Measured: At the end of immuno-chemotherapy up to 4-6 months
Secondary outcomes (3)
RCB level
Residual Cancer Burden (RCB) level is a classification system used to assess the amount of cancer remaining in the breast tissue and lymph nodes after neoadjuvant chemotherapy. It is determined by evaluating several factors including the primary tumor area, the percentage of the tumor area that is invasive cancer, and the extent of lymph node involvement. The RCB index categorizes patients into four groups from group 0 to III indicating none to extensive residual cancer burden.
Measured: breast surgery up to 4-6 months after trial initiation
TILs
Changes in the tumor-infiltrating lymphocyte score (TILs), as determined by the Salgado criteria, indicate an engagement of the immune system in cancer, with scores ranging from 0 to 100%. A higher score in TILs correlates with improved patient outcomes. The planned collection of biopsy samples at three critical points-before treatment, after the initial dose of Toripalimab with or without radiation therapy, and at the time of surgical resection-will enable a comprehensive serial evaluation of TILs. This approach will help to quantify the impact of radiation therapy on the immune response induced by Toripalimab.
Measured: Pre-treatment, post-initial dose of Toripalimab with or without radiation up to 4 weeks, and at surgical resection up to 4-6 months.
SBRT-related Adverse Events
Treatment toxicities. radiation-related AEs, especially Acute Radiation Dermatitis.
Measured: at least once a week within 2-4 weeks after the start of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start26 Dec 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 74 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671262
- Sponsor's protocol ID
- Y2024-0857
- Acronym
- NEOTRIO-HR
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer（NEOTRIO-HR）
- ClinicalTrials.gov ID
- NCT06671262
- Acronym / sponsor ID
- NEOTRIO-HR / Y2024-0857
- Conditions
- Breast Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 4 Nov 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.
The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are:
- Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？
- Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?
Participants will be randomly assigned to one of three treatment regimens:
- Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;
- Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;
- Preoperative toripalimab combined with chemotherapy alone.
Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.
The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.
Detailed description
Breast cancer is a leading malignancy among women globally, with early diagnosis and treatment being crucial for better outcomes. Over 90% of breast cancer patients are diagnosed at an early stage, and approximately two-thirds have the hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) subtype. Despite this, these patients often exhibit resistance to neoadjuvant chemotherapy, with a pathologic complete response (pCR) rate of only 5-15%, which is significantly lower compared to other subtypes and is associated with poor prognosis. This indicates the necessity for optimizing current treatment strategies.
In recent years, significant advancements have been made in the application of immunotherapy for breast cancer. The studies demonstrated that the addition of immune checkpoint inhibitors to neoadjuvant chemotherapy for patients with high-risk early-stage HR+/HER2- breast cancer significantly improved pCR rates.
Building on these findings, this study proposes a novel strategy of dose-intensified radiation to the tumor (tumor boost) during the neoadjuvant immuno-chemotherapy phase. The advantage of this approach is that it can activate the immune system while the tumor tissue is still intact, providing a rich source of tumor antigens, which aids in enhancing the immune system's recognition and destruction of cancer cells.
Toripalimab is an optimal immunotherapy agent to study, as this agent has recently been approved by the FDA for use in multiple tumor types. It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments. This study will provide valuable insights into the potential of immunotherapy in combination with radiotherapy to improve outcomes for patients with lymph nodes-positive, high-risk HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Drug: Immuno-chemotherapyPatients in this arm receive only a single injection of toripalimab without any radiotherapy as an initial treatment. After a three-week interval, patients receive the standard neoadjuvant chemotherapy in combination with toripalimab, starting with four cycles of paclitaxel and toripalimab, followed by four cycles of epirubicin and toripalimab. |
| The SBRT-combined group 1 | Experimental | Radiation: SBRT, Drug: Immuno-chemotherapyPatients enrolled in this treatment arm will undergo SBRT focused on the primary tumor, receiving a total dose of 24Gy divided into three fractions over the course of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days post-treatment. After a three-week rest period, patients will commence the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen will begin with four cycles of paclitaxel combined with toripalimab and followed by four cycles of epirubicin combined with toripalimab. |
| The SBRT-combined group 2 | Experimental | Radiation: SBRT, Drug: Immuno-chemotherapyIn this treatment protocol, patients will receive a total radiation dose of 24Gy in three fractions, specifically targeting the primary tumor. Concurrently, the axillary lymph nodes will be treated with a dose of 9Gy in three fractions. This radiation therapy will be conducted over a period of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days after the completion of the radiation treatment. After a three-week interval, patients will proceed with the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen includes an initial phase of four cycles of paclitaxel paired with toripalimab, which will be followed by a subsequent phase of four cycles of epirubicin paired with toripalimab. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High-risk HR+/HER2-negative breast cancer is defined as ER≥1%, HER2-negative (<2+ Her2 IHC or <2.2 HER2/CEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;
- Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;
- The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)< 10%;
- ECOG score of 0-1;
- Screening laboratory values must meet the following criteria: i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
Key exclusion criteria (7 listed)
- Inflammatory breast cancer
- Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);
- Clinically symptomatic heart disease;
- Previous systemic treatment or radiotherapy for breast cancer;
- Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;
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 |
|---|---|---|
| SBRTTarget the primary tumor region with a single dose of 8Gy, or deliver a dose of 3Gy to the axillary lymph nodes, administered once a day for three consecutive days. | Radiation | The SBRT-combined group 1, The SBRT-combined group 2 |
| Immuno-chemotherapyStandard new adjuvant treatment with toripalimab combined with chemotherapy, that is in the first phase consisting of paclitaxel and toripalimab for four cycles, followed by epirubicin, cyclophosphamide, and toripalimab for another four cycles. | Drug | The SBRT-combined group 1, The SBRT-combined group 2, The control group |
Primary outcome
pCR rate
Time frame: At the end of immuno-chemotherapy up to 4-6 months
Pathological Complete Response (pCR) is characterized by the absence of any invasive residual primary tumor in both the breast and lymph nodes. The primary objective of this study is to compare the pCR rates between two treatment approaches: neoadjuvant toripalimab combined with SBRT followed by immuno-chemotherapy, and neoadjuvant toripalimab combined with chemotherapy.
3 secondary outcomes
RCB level
Time frame: breast surgery up to 4-6 months after trial initiation
TILs
Time frame: Pre-treatment, post-initial dose of Toripalimab with or without radiation up to 4 weeks, and at surgical resection up to 4-6 months.
SBRT-related Adverse Events
Time frame: at least once a week within 2-4 weeks after the start of radiotherapy.
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 11 Feb 2025.
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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 SBRT and Immuno-chemotherapy in people with Breast Adenocarcinoma, run by Second Affiliated Hospital, Zhejiang 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 5 inclusion and 7 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 11 Feb 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 Jian Huang (+86-13958123068, drhuangjian@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: At the end of immuno-chemotherapy up to 4-6 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 11 Feb 2025.