Triple Negative Breast Cancer (TNBC)NCT07187674
The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel
A study testing Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in people with Triple Negative Breast Cancer (TNBC), run by Harbin Medical University.
Trial summary
Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Iparomlimab and tuvonralimab combined with olaparib and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join this study and sign an informed consent form;
- Women aged ≥ 18 years and ≤ 70 years with early breast cancer:According to the definition of the latest ASCO/CAP guidelines, triple negative breast cancer patients with T1cN1-2 or T2-4N0-2 stage confirmed by histopathology;
- Subjects with HRD positive tumor tissue evaluation;
- According to RECIST 1.1, there must be at least one measurable lesion;
- ECOG score: 0 to 1;
- Tumor tissue specimens that can be used for biomarker detection;
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- The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication):
- Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group); Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; AKP≤ 2.5×ULN； Serum creatinine ≤ 1.5 × ULN;
- Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; ; And must be non lactation; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of trial drugs.
Who cannot join
- There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included);
- Currently using immunosuppressants or systemic hormone therapy for immunosuppression (with a dosage of >10mg/day of prednisone or other equally effective hormones), and still continuing to use them within 2 weeks prior to enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Known history or evidence of interstitial lung disease or active non infectious pneumonia;
- Having other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- Have hypertension and can not be well controlled after antihypertensive drug treatment; Had hypertension crisis or hypertensive encephalopathy in the past;
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- There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) qtc>450ms (male); Qtc>470ms (female);
- The urine routine showed that the urine protein was ≥ + +, and the 24-hour urine protein volume was confirmed to be >1.0 g;
- Patients with active infection, unexplained fever ≥ 38.5 ℃ within 7 days before medication, or white blood cell count >15 × 10^9/l at baseline;
- Have congenital or acquired immune deficiency (such as HIV infected persons); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 iu/ml, or hepatitis C virus antibody positive;
- Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period;
- Bilateral breast cancer;
- According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of 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: Single Arm, Prospective, Small Sample, Exploratory Clinical Study on the Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab(QL1706)Combined With Olaparib and Paclitaxel
Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. In 2022, the estimated number of new cases of female breast cancer worldwide is 2.389 million, and the estimated number of deaths is 666000. Triple negative breast cancer (TNBC) refers to breast cancer that is negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, accounting for about 10% - 20% of malignant breast tumors. . At present, chemotherapy is still the main means of clinical treatment of TNBC, but the heterogeneity of TNBC in molecular level, pathology and clinical characteristics leads to different sensitivity of patients to different chemotherapeutic drugs, especially the sensitivity of most elderly patients to chemotherapeutic drugs is not high, and the prognosis is poor.
The development of immunotherapy in the field of breast cancer has witnessed the continuous deepening of medical understanding of cancer treatment. In the past, breast cancer was often regarded as a "cold tumor" insensitive to immunotherapy, but with the deepening of research, immunotherapy gradually occupied an important position in the treatment of breast cancer. The ongoing research hopes to identify patients who may benefit more from immunotherapy according to their respective tumor immune microenvironment.
Read more
Its mechanism of action mainly includes two aspects: one is to restore the normal recognition and attack ability of the immune system to tumor cells and break the immune escape mechanism of tumor cells; The second is to stimulate a lasting immune response, so that the immune system can continuously monitor and clear tumor cells.
Therefore, this study intends to evaluate the efficacy and safety of Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in the neoadjuvant treatment of early high-risk TNBC with HRD positive.
It is planned to enroll 20 subjects. After enrollment, the subjects will receive six cycles of combination therapy with olaparib and docetaxel. Take 3 weeks as a treatment cycle until the treatment termination event specified in the protocol occurs, and the subject will continue to conduct postoperative efficacy and safety visits after the end of treatment.
After neoadjuvant treatment, according to the routine treatment process of breast cancer, the subject will receive breast cancer surgery; After surgical treatment, according to the residual breast lesions of the patient, the attending physician and the subject will agree on the subsequent treatment plan.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Iparomlimab and tuvonralimab combined with olaparib and paclitaxel
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and tuvonralimab combined with olaparib and paclitaxelDrug
The main objective of this study is to evaluate the tpCR of early high-risk TNBC with HRD positive treated with Iparomlimab and tuvonralimab combined with olaparib and paclitaxel as neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and tuvonralimab combined with olaparib and paclitaxel | Experimental | Not described Receives: Drug: Iparomlimab and tuvonralimab combined with olaparib and paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological Complete Response (tpCR)
No invasive cancer cells in breast and axilla（ypT0/is N0）
Measured: 5 months
Secondary outcomes (5)
Breast Pathological Complete Respons(bpCR)
According to the evaluation method recommended by the international breast collaboration group：There is no residual invasive carcinoma in the primary breast lesion and regional lymph nodes, or only carcinoma in situ (such as ductal carcinoma in situ) remains. If there are solitary tumor cells or micrometastases in lymph nodes, it is still judged as non PCR。
Measured: 5 months
Objective Response Rate(ORR)
Objective response rates assessed according to RECIST 1.1 criteria
Measured: 12 months
3-year Disease Free Survival
The 3-year survival of Wu Bing evaluated according to RECIST 1.1 criteria
Measured: 40 months
Ratio of Residual Cancer Burden (RCB) 0-1
The RCB index is calculated by measuring indicators such as the size of the tumor bed, cell density, the proportion of in situ cancer, and lymph node metastasis
Measured: 5 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Dec 2025 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Wang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187674
- Sponsor's protocol ID
- IITGC-1645-0513
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Prospective, Small Sample, Exploratory Clinical Study on the Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab(QL1706)Combined With Olaparib and Paclitaxel
- ClinicalTrials.gov ID
- NCT07187674
- Acronym / sponsor ID
- IITGC-1645-0513
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 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.
Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. In 2022, the estimated number of new cases of female breast cancer worldwide is 2.389 million, and the estimated number of deaths is 666000. Triple negative breast cancer (TNBC) refers to breast cancer that is negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, accounting for about 10% - 20% of malignant breast tumors. . At present, chemotherapy is still the main means of clinical treatment of TNBC, but the heterogeneity of TNBC in molecular level, pathology and clinical characteristics leads to different sensitivity of patients to different chemotherapeutic drugs, especially the sensitivity of most elderly patients to chemotherapeutic drugs is not high, and the prognosis is poor.
The development of immunotherapy in the field of breast cancer has witnessed the continuous deepening of medical understanding of cancer treatment. In the past, breast cancer was often regarded as a "cold tumor" insensitive to immunotherapy, but with the deepening of research, immunotherapy gradually occupied an important position in the treatment of breast cancer. The ongoing research hopes to identify patients who may benefit more from immunotherapy according to their respective tumor immune microenvironment.
Its mechanism of action mainly includes two aspects: one is to restore the normal recognition and attack ability of the immune system to tumor cells and break the immune escape mechanism of tumor cells; The second is to stimulate a lasting immune response, so that the immune system can continuously monitor and clear tumor cells.
Therefore, this study intends to evaluate the efficacy and safety of Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in the neoadjuvant treatment of early high-risk TNBC with HRD positive.
It is planned to enroll 20 subjects. After enrollment, the subjects will receive six cycles of combination therapy with olaparib and docetaxel. Take 3 weeks as a treatment cycle until the treatment termination event specified in the protocol occurs, and the subject will continue to conduct postoperative efficacy and safety visits after the end of treatment.
After neoadjuvant treatment, according to the routine treatment process of breast cancer, the subject will receive breast cancer surgery; After surgical treatment, according to the residual breast lesions of the patient, the attending physician and the subject will agree on the subsequent treatment plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and tuvonralimab combined with olaparib and paclitaxel | Experimental | Drug: Iparomlimab and tuvonralimab combined with olaparib and paclitaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily join this study and sign an informed consent form;
- Women aged ≥ 18 years and ≤ 70 years with early breast cancer:According to the definition of the latest ASCO/CAP guidelines, triple negative breast cancer patients with T1cN1-2 or T2-4N0-2 stage confirmed by histopathology;
- Subjects with HRD positive tumor tissue evaluation;
- According to RECIST 1.1, there must be at least one measurable lesion;
- ECOG score: 0 to 1;
Key exclusion criteria (13 listed)
- There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included);
- Currently using immunosuppressants or systemic hormone therapy for immunosuppression (with a dosage of >10mg/day of prednisone or other equally effective hormones), and still continuing to use them within 2 weeks prior to enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Known history or evidence of interstitial lung disease or active non infectious pneumonia;
- Having other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
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 |
|---|---|---|
| Iparomlimab and tuvonralimab combined with olaparib and paclitaxelThe main objective of this study is to evaluate the tpCR of early high-risk TNBC with HRD positive treated with Iparomlimab and tuvonralimab combined with olaparib and paclitaxel as neoadjuvant therapy | Drug | Iparomlimab and tuvonralimab combined with olaparib and paclitaxel |
Primary outcome
Total Pathological Complete Response (tpCR)
Time frame: 5 months
No invasive cancer cells in breast and axilla（ypT0/is N0）
5 secondary outcomes
Breast Pathological Complete Respons(bpCR)
Time frame: 5 months
Objective Response Rate(ORR)
Time frame: 12 months
3-year Disease Free Survival
Time frame: 40 months
Ratio of Residual Cancer Burden (RCB) 0-1
Time frame: 5 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 40 months
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 23 Sep 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.
Questions about this trial
What is this clinical trial studying?
A study testing Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in people with Triple Negative Breast Cancer (TNBC), run by Harbin Medical University.
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 9 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 23 Sep 2025. 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.
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 Jin song Wang S Wang (0451-86298091, taowangto2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathological Complete Response (tpCR) (time frame: 5 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 23 Sep 2025.