HR-positive,HER2-negative Breast CancerPhase 2NCT06705127
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
A Phase 2 study testing TORIPALIMAB INJECTION(JS001 ) and Stereotactic Body Radiation Therapy (SBRT) in people with HR-positive,HER2-negative Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HR-positive,HER2-negative Breast Cancer
- What is being tested?
- TORIPALIMAB INJECTION(JS001 ) and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender is not limited;
- Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67>20%;
- T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;
- No previous treatment;
- ECOG PS 0-1 score;
- The subject or legal representative has been informed of the nature of the study, understands the protocol, is able to guarantee compliance, and signs the informed consent
Who cannot join
- Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components;
- Currently participating in and receiving other research treatment;
- Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.;
- Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;
- Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening;
- Uncontrolled or symptomatic hypercalcemia (\> 1.5mmol/L calcium ion or calcium \> 12mg/dL or corrected serum \> ULN);
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- Clinically uncontrolled active infections, including but not limited to acute pneumonia;
- Uncontrollable major seizures or superior vena cava syndrome;
- previous or current co-occurrence of other malignant tumors (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder carcinoma and other in situ cancers that have been treated radically and have no evidence of disease recurrence);
- Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, chest CT screening found evidence of active pneumonia or other moderate to severe lung diseases that seriously affect lung function;
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within the first 6 months of enrollment;
- received systemic immunosuppressive drugs (i.e. use of corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years prior to study initiation;
- Received live virus vaccine within 4 weeks prior to study initiation;
- Patients who have previously received allogeneic stem cells or parenchymal organ transplants;
- Pregnant or lactating women or women who have the possibility of becoming pregnant have tested positive for pregnancy before the first drug use, and patients who are fertile but do not want to take contraceptive measures or their sexual partners do not want to take contraceptive measures
- Any other clinically significant illness or condition that the investigator believes could affect adherence to the protocol (such as a history of mental illness or substance abuse), prevent the patient from benefiting from the clinical study, or prevent the patient from signing informed consent (such as drug use and substance abuse), or make participation in the clinical study inappropriate (including but not limited to: Abnormal laboratory results, clinical active diverticulitis, abdominal abscess, intestinal obstruction, and peritoneal metastases).
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
the First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Peifen Fu, MD, 0571-87236852, fupeifen@zju.edu.cn
About this study
Official title: A Phase II,Single-arm,Multicenter Study of Radiotherapy Followed by Chemotherapy Combined With Toripalimab Immunotherapy in Local Advanced HR-positive,HER2-negative Breast Cancer.
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.
Read the detailed description
Breast cancer is the first malignant tumor in women worldwide, and its incidence is still increasing year by year. Compared with developed countries in Europe and the United States, although the incidence of breast cancer in China is low, it is showing a rapid growth trend, and due to practical factors such as large population base and unbalanced distribution of medical resources, the overall stage of initial diagnosis of breast cancer patients in China is later than that in developed countries in Europe and the United States, and the proportion of local advanced and advanced breast cancer patients is higher. As the overall prognosis of early breast cancer patients is good, how to further improve the therapeutic effect of locally advanced and advanced breast cancer patients has become the main pass to improve the overall prognosis of breast cancer. In the comprehensive treatment strategy of breast cancer, radiotherapy is an indispensable part of local treatment. In the past, the understanding of the antitumor effect of radiotherapy was mainly limited to the dormancy or lytic death of tumor cells caused by DNA damage in tumor cells caused by X-ray. However, in recent years, with the deepening of research on tumor microenvironment and immunotherapy, researchers have gradually revealed the remodeling effect of radiotherapy on tumor microenvironment. We designed this clinical study of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab immunotherapy to explore the effect of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab on postoperative pCR rate and prognosis of patients with locally advanced HR-positive and HER2-negative breast cancer.
- Conditions
- HR-positive,HER2-negative Breast Cancer
- Being tested
- TORIPALIMAB INJECTION(JS001 ), Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- HR-positive,HER2-negative Breast Cancer, Local Advanced, Toripalimab, Radiotherapy, Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORIPALIMAB INJECTION(JS001 )Drug
Also called Epirubicin, cyclophosphamide, nab-paclitaxel
Drug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1, followed by the first day of each course for 18 cycles, a total of 1 year.
Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles.
Drug D:albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab treatment group | Experimental | Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy.
Drug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1,followed by the first day of each course for 18 cycles, a total of 1 year.
Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles.
Drug D: albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles. Receives: Drug: TORIPALIMAB INJECTION(JS001 ); Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response（pCR）
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Measured: Up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-positive,HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peifen Fu, MD, Principal investigator, Zhejiang UniversitySenxiang Yan, MD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705127
- Sponsor's protocol ID
- 2024-114
- Status last verified
- Sep 2024
- First submitted
- 24 Nov 2024
- Last updated
- 26 Nov 2024
- 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II,Single-arm,Multicenter Study of Radiotherapy Followed by Chemotherapy Combined With Toripalimab Immunotherapy in Local Advanced HR-positive,HER2-negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT06705127
- Acronym / sponsor ID
- 2024-114
- Conditions
- HR-positive,HER2-negative Breast Cancer
- Keywords
- HR-positive,HER2-negative Breast Cancer, Local Advanced, Toripalimab, Radiotherapy, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 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.
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.
Detailed description
Breast cancer is the first malignant tumor in women worldwide, and its incidence is still increasing year by year. Compared with developed countries in Europe and the United States, although the incidence of breast cancer in China is low, it is showing a rapid growth trend, and due to practical factors such as large population base and unbalanced distribution of medical resources, the overall stage of initial diagnosis of breast cancer patients in China is later than that in developed countries in Europe and the United States, and the proportion of local advanced and advanced breast cancer patients is higher. As the overall prognosis of early breast cancer patients is good, how to further improve the therapeutic effect of locally advanced and advanced breast cancer patients has become the main pass to improve the overall prognosis of breast cancer. In the comprehensive treatment strategy of breast cancer, radiotherapy is an indispensable part of local treatment. In the past, the understanding of the antitumor effect of radiotherapy was mainly limited to the dormancy or lytic death of tumor cells caused by DNA damage in tumor cells caused by X-ray. However, in recent years, with the deepening of research on tumor microenvironment and immunotherapy, researchers have gradually revealed the remodeling effect of radiotherapy on tumor microenvironment. We designed this clinical study of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab immunotherapy to explore the effect of neoadjuvant radiotherapy sequential chemotherapy combined with terriplizumab on postoperative pCR rate and prognosis of patients with locally advanced HR-positive and HER2-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab treatment group | Experimental | Drug: TORIPALIMAB INJECTION(JS001 ), Radiation: Stereotactic Body Radiation Therapy (SBRT)Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy. Drug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1,followed by the first day of each course for 18 cycles, a total of 1 year. Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles. Drug D: albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years old, gender is not limited;
- Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67>20%;
- T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;
- No previous treatment;
- ECOG PS 0-1 score;
Key exclusion criteria (17 listed)
- Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components;
- Currently participating in and receiving other research treatment;
- Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.;
- Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;
- Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening;
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 |
|---|---|---|
| TORIPALIMAB INJECTION(JS001 )Also: Epirubicin, cyclophosphamide, nab-paclitaxelDrug A: 240mg intravenous infusion of Toripalimab, once every 3 weeks, the first dosing date was C1D1, followed by the first day of each course for 18 cycles, a total of 1 year. Drugs B and C: Epirubicin was administered intravenously after the dosage was calculated at 90mg/m2 body surface area, cyclophosphamide was calculated at 600mg/m2 body surface area by intravenous micropump, both drugs were administered every 3 weeks, the first administration date was C1D1, and then the first day of each course was administered for 4 cycles. Drug D:albumin paclitaxel was given intravenatically at a dose of 125mg/m2 body surface area, once a week, with the first administration date of C5D1, and then on the first day of each course for 12 cycles. | Drug | Toripalimab treatment group |
| Stereotactic Body Radiation Therapy (SBRT)Local radiotherapy: Subjects received stereotactic radiotherapy for the primary breast cancer lesion at 8Gy each time for 3 consecutive days, once a day, 2 weeks before the start of systemic therapy | Radiation | Toripalimab treatment group |
Primary outcome
Pathologic complete response（pCR）
Time frame: Up to12 months
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
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 Nov 2024.
- 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.
Peifen Fu, MD principal investigator
Zhejiang University
Senxiang Yan, MD principal investigator
Zhejiang University
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 TORIPALIMAB INJECTION(JS001 ) and Stereotactic Body Radiation Therapy (SBRT) in people with HR-positive,HER2-negative Breast Cancer, run by First Affiliated Hospital of Zhejiang University 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 6 inclusion and 17 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 Nov 2024. 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 Peifen Fu, MD (0571-87236852, fupeifen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response（pCR） (time frame: Up to12 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 26 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.