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HR+/HER2- Breast CancerPhase 3NCT06977893

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)

A Phase 3 study testing Neoadjuvant Chemotherapy in Combination with Toripalimab and Neoadjuvant Chemotherapy in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HR+/HER2- Breast Cancer
What is being tested?
Neoadjuvant Chemotherapy in Combination with Toripalimab and Neoadjuvant Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
13 sitesChina
Study dates
24 Mar 2025to 23 Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-75 years old;
  • ECOG score is 0-1 points;
  • breast cancer meets the following standards: Histologically confirmed invasive breast cancer with tumor diameter\>1cm (T1c-3; N0-3; M0). All patients were pathohistologically confirmed as HR+/HER2- breast cancer. According to the breast cancer diagnosis and treatment guidelines and specifications of the Chinese Anti Cancer Association (2021 version), Luminal B is divided into Luminal B (HER2 negative) and Luminal B (HER2 positive). Luminal B (HER2 negative) is ER/PR positive, HER2 negative and Ki-67 proliferation index is high or PR low expression. Luminal type B (HER2 positive) is ER/PR positive, HER2 positive (protein overexpression or gene amplification), and Ki-67 in any state. Therefore, HR+/HER2- breast cancer is a Luminal type breast cancer patient excluding HER2+.
  • Pathological examination of PD-L1 expression:
  • The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.
  • The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of...)
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  • Using leukocyte and platelet boosting drugs:
  • Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; platelet count (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater than 90g/L; Lymphocyte count ≥ 1.5 × 109/L
  • Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanine aminotransferase ALT and aspartate levels are less than 1.5 × ULN; Alkaline phosphatase is less than 2.5 × ULN; Urea nitrogen/ Urea (BUN/UREA) and creatinine (Cr) are less than 1.5 × ULN.
  • Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.
  • 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
  • 6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

Who cannot join

  • Stage IV breast cancer.
  • Inflammatory breast cancer.
  • Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
  • Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
  • The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
  • Serious heart disease or discomfort, including but not limited to the following diseases:
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  • 1) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).
  • 2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).
  • 3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg). 7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
  • 8. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment [HBV-DNA test negative or\<50IU/ml] and cured hepatitis C patients [HCV RNA test negative]).
  • 9. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.
  • 10. Individuals with a known history of allergies to the components of this medication regimen.
  • 11. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.
  • 12. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhijun Dai, Professor contact

+86 157 0581 9132

dzj0911@126.com

13 sites in 1 country

China13 sites, 13 recruiting
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou

    Heming Zheng

    Not yet recruiting
  • The First Affiliated Hospital of Zhejiang University

    Hangzhou

    Zhijun Dai, Professor, +86 157 0581 9132, dzj0911@126.com

    Youyi Chen Chen, 913589289@qq.com

    Recruiting
  • Zhejiang Cancer Hospital

    Hangzhou

    Yang Yu

    Recruiting
  • Harbin Medical University Cancer Hospital

    Harbin

    Tong Liu

    Not yet recruiting
  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Ying Chen

    Not yet recruiting
  • Jinhua Municipal Central Hospital

    Jinhua

    Chaoyang Xu

    Not yet recruiting
  • Nanchang People's Hospital

    Nanchang

    Yili Wang

    Not yet recruiting
  • Nantong First People's Hospital

    Nantong

    Jian Qiu

    Not yet recruiting
  • Zhongshan Hospitall, Fudan University

    Shanghai

    Wei Zhu

    Not yet recruiting
  • Xinjiang Medical University Affiliated Cancer Hospital

    Ürümqi

    Hongtao Li

    Not yet recruiting
  • Shaanxi Provincial Cancer Hospital

    Xi'an

    Xiaomin Yang

    Not yet recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Huafeng Kang

    Not yet recruiting
  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Pengwei Lv

    Not yet recruiting

Other trials in China

About this study

Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response(PCR)and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.

Being tested
Neoadjuvant Chemotherapy in Combination with Toripalimab, Neoadjuvant Chemotherapy
Keywords
Breast cancer, Toripalimab, Adjuvant Chemotherapy, Immunotherapy, HR-positive HER2-negative
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant Chemotherapy in Combination with ToripalimabDrug

    Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.

  • Neoadjuvant ChemotherapyDrug

    Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks.

Study groups in NCT06977893
Study groupRoleWhat they receive
Experimental Group: Neoadjuvant Chemotherapy in Combination with ToripalimabExperimentalDrug: Neoadjuvant Chemotherapy in Combination with Toripalimab Description: Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.
Receives: Drug: Neoadjuvant Chemotherapy in Combination with Toripalimab
Control Group: Neoadjuvant ChemotherapySham comparatorDrug: Neoadjuvant Chemotherapy Description: Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks.
Receives: Drug: Neoadjuvant Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response(PCR)

    The primary study objective is to evaluate the pathologic complete response(PCR) of the control group and experimental group.

    Measured: 2 years

  2. RCB 0-1 Ratio

    Measured: 2 years

Secondary outcomes (2)
  1. Event Free Survival(EFS)

    Event Free Survival (EFS) refers to the time from the start of randomization (the start of treatment in a single-arm trial) to the first occurrence of any of the following events: disease progression that makes surgical treatment impossible, local or distant recurrence, death due to any cause, etc. It can be used to evaluate the effectiveness of the drug.

    Measured: 5 years

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is a key indicator used in medical research, especially in oncology, to evaluate the effectiveness of a treatment. It refers to the proportion of patients whose tumor volume shrinks to a certain extent and remains in that state for a specific period of time after receiving a particular treatment.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start24 Mar 2025
  3. Primary completion23 Mar 2027 (estimated)
  4. Study completion23 Mar 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06977893
Sponsor's protocol ID
IIT20250026C
Status last verified
May 2025
First submitted
12 May 2025
Last updated
18 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant Chemotherapy in Combination with Toripalimab and Neoadjuvant Chemotherapy in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 13 sites 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 12 inclusion and 14 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Zhijun Dai, Professor (+86 157 0581 9132, dzj0911@126.com), 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: 2 years). The study lists 2 primary outcomes in all. 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 18 May 2025.

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