Breast CancerPhase 2NCT06178159
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
A Phase 2 study testing Disitamab Vedotin Injection, Pertuzumab Injection and Toripalimab in people with Breast Cancer, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disitamab Vedotin Injection, Pertuzumab Injection and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign the informed consent form;
- Ages≥18 years;
- Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter > 2 cm), cN0- 3, M0;
- Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;
- Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic therapy for breast cancer, as assessed by site.
- At least one measurable lesion according to RECIST v1.1 criteria;
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- Cardiac function: New York Heart Association (NYHA) class <3; left ventricular ejection fraction ≥55%;
- Bone marrow or organ function, the following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial centre, no transfusion of blood, haematopoietic stimulating factors, albumin or blood products within 14 days prior to the test): haemoglobin ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; platelets ≥ 100 × 109 /L; serum total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN); Albuminous Transaminase (AST) and Albuminous Transaminase (ALT) ≤ 2.5 × ULN; International Normalised Ratio (INR) and Activated Fractional Thromboplastin Time ≤ 1.5 × ULN; and Creatinine Clearance (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula method;
- Subjects of childbearing potential who meet the following criteria:
- A serum pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of β-human chorionic gonadotropin [β-hCG]) must be negative within 72 hours prior to the first dose of study intervention. Subjects with false-positive results and confirmed non-pregnancy will be eligible for participation in the study.
- Must agree to contraception for the duration of the study and for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
- Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
- If sexually active and likely to result in pregnancy, use of at least 2 acceptable contraceptive methods, at least 1 of which must be highly effective, must be continued from the time of informed consent for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
- Subjects of childbearing potential who meet the following criteria:
- Must agree not to donate sperm from the time of signing the informed consent until at least 4 months after the last dose of study drug (7 months after the last dose of patulizumab).
- If sexual intercourse with a person of childbearing potential is likely to result in pregnancy, the use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective, must be continuous, beginning at the time of informed consent and continuing until at least 4 months after the last dose of study drug (7 months after the last dose of patuximab).
- If sex with a pregnant or breastfeeding patient, condom use must be continued from the start of informed consent and continue until at least 4 months after the last dose of study drug (7 months after the last dose of patuximab).
- 12. Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow up procedural arrangements.
Who cannot join
- With bilateral invasive breast cancer
- Previous history of invasive breast cancer
- Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
- Prior anti-HER2 therapy including but not limited to ADC
- Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
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- Vaccination with live or live attenuated vaccine within 4 weeks prior to the start of study drug administration or planned for the duration of the study;
- History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation;
- Uncontrolled or significant cardiovascular disease, including (but not limited to): any of the following within 6 months prior to the first dose: e.g., congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (except for lacunar cerebral infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathy (e.g., dilated cardiomyopathy, Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); history of clinically significant prolongation of the QTc period, grade II type II AV block or grade III AV block or QTc interval (F method) >470 msec (women) or >450 msec (men); atrial fibrillation (EHRA grade ≥2b); uncontrolled hypertension that is judged by the investigator to be unsuitable; and Hypertension, judged by the investigator to be unsuitable for participation in the study;
- History of interstitial lung disease requiring treatment or current severe lung disease including, but not limited to, active tuberculosis, interstitial lung disease;
- A clear past or present history of a neurological or psychiatric disorder, including epilepsy or dementia;
- Persistent grade ≥2 sensory or motor neuropathy;
- Active infection requiring systemic therapy; active infection requiring systemic therapy ≤7 days prior to study drug administration, with routine antimicrobial prophylaxis permitted; positive HIV test results; patients with active hepatitis B or C (HBsAg positivity with HBV DNA titres above the upper limit of normal; HCVAb positivity with HCV RNA titres above the upper limit of normal); and persistent coronavirus (COVID-19) infection.
- Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of corticosteroids or immunosuppressive drugs, etc.), allowing for related replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency);
- Other malignancy within 5 years prior to signing the Informed Consent Form (with the exception of non-melanoma skin cancer, cervical carcinoma in situ, limited prostate cancer, stage I endometrial cancer, or other tumours that have been effectively treated and are considered to have been cured);
- Hypersensitivity reactions or delayed hypersensitivity reactions to certain components of vedicilizumab, patulizumab and treprostinil or similar drugs are known;
- A concomitant disease that, in the judgement of the investigator, is a serious hazard to the safety of the subject or interferes with the subject's ability to complete the clinical study;
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433
Jiong Wu, Ph.D
About this study
Official title: A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
Read the detailed description
This is an open-label, randomized, multicenter, Phase II Study designed to evaluate safety and efficacy of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy inr patients with HER2-positive breast cancer.
The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HER2-positive breast cancer, by assessment of pCR .
- Conditions
- Breast Cancer
- Being tested
- Disitamab Vedotin Injection, Pertuzumab Injection, Toripalimab
- Keywords
- Breast Cancer, HER2-positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin InjectionDrug
Also called DV,RC48-ADC
2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.
Pertuzumab InjectionDrug
Initial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks
ToripalimabDrug
Also called JS001
3.0 mg/kg, intravenous infusion, D1, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin + Pertuzumab | Experimental | Disitamab Vedotin With Pertuzumab arm Receives: Drug: Disitamab Vedotin Injection; Drug: Pertuzumab Injection |
| Disitamab Vedotin + Toripalimab+ Pertuzumab | Experimental | Disitamab Vedotin+ Toripalimab with Pertuzumab arm Receives: Drug: Disitamab Vedotin Injection; Drug: Pertuzumab Injection; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate (ypT0/is ypN0)
Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ);
Measured: 1 month after surgery
Secondary outcomes (10)
Objective remission rate (ORR)
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Measured: Up to approximately 2 years
Disease free survival（DFS）
From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause including 3- and 5-year event-free survival
Measured: Up to approximately 5 years
Event free survival (EFS)
The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause;
Measured: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from the date of randomisation until the date of death due to any cause.
Measured: Date of randomization to date of death due to any cause, up to 5 years after the last subject randomized
Adverse events
To evaluate safety including adverse event rate and adverse event grade
Measured: Up to approximately 2 months after surgery
Change in cluster of differentiation 8 (CD8)
CD8 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.
Measured: At baseline to surgery
Health-related quality of life - EORTC-QLQ-C30
Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden
Measured: Up to approximately 2 years
Residual cancer burden score
According to the extent of the residual cancer in the primary breast cancer site (mm*mm), the residual cancer (mm*mm), cell density of residual cancer (%), proportion of carcinoma in situ (%), number of positive lymph nodes and maximum diameter of lymph node metastasis (mm), the RCB index and corresponding RCB classification can be obtained. The RCB index and the corresponding RCB grade can be obtained based on the maximum diameter of the cancer (mm).
Measured: 1 month after surgery
Change in tumor-infiltrating lymphocytes (TILs)
Defined as infiltrating lymphocytes isolated from tumor tissue.TILs in tumor samples by biopsy right before the first neoadjuvant therapy (baseline) and by surgery immediately after surgery would be evaluated by HE or immune staining。
Measured: At baseline to surgery
Change in programmed cell death protein L1 (PD-L1)
PD1 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.
Measured: At baseline to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start28 Nov 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Fang, Ph.D, Study director, RemeGen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178159
- Sponsor's protocol ID
- RC48-C026
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2023
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06178159
- Acronym / sponsor ID
- RC48-C026
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, HER2-positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2023 (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 purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
Detailed description
This is an open-label, randomized, multicenter, Phase II Study designed to evaluate safety and efficacy of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy inr patients with HER2-positive breast cancer.
The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HER2-positive breast cancer, by assessment of pCR .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin + Pertuzumab | Experimental | Drug: Disitamab Vedotin Injection, Drug: Pertuzumab InjectionDisitamab Vedotin With Pertuzumab arm |
| Disitamab Vedotin + Toripalimab+ Pertuzumab | Experimental | Drug: Disitamab Vedotin Injection, Drug: Pertuzumab Injection, Drug: ToripalimabDisitamab Vedotin+ Toripalimab with Pertuzumab arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily participate and sign the informed consent form;
- Ages≥18 years;
- Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter > 2 cm), cN0- 3, M0;
- Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;
- Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic therapy for breast cancer, as assessed by site.
Key exclusion criteria (17 listed)
- With bilateral invasive breast cancer
- Previous history of invasive breast cancer
- Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
- Prior anti-HER2 therapy including but not limited to ADC
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 |
|---|---|---|
| Disitamab Vedotin InjectionAlso: DV,RC48-ADC2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed. | Drug | Disitamab Vedotin + Pertuzumab, Disitamab Vedotin + Toripalimab+ Pertuzumab |
| Pertuzumab InjectionInitial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks | Drug | Disitamab Vedotin + Pertuzumab, Disitamab Vedotin + Toripalimab+ Pertuzumab |
| ToripalimabAlso: JS0013.0 mg/kg, intravenous infusion, D1, every 2 weeks | Drug | Disitamab Vedotin + Toripalimab+ Pertuzumab |
Primary outcome
Pathological complete response (pCR) rate (ypT0/is ypN0)
Time frame: 1 month after surgery
Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ);
10 secondary outcomes
Objective remission rate (ORR)
Time frame: Up to approximately 2 years
Disease free survival（DFS）
Time frame: Up to approximately 5 years
Event free survival (EFS)
Time frame: Up to approximately 5 years
Overall survival (OS)
Time frame: Date of randomization to date of death due to any cause, up to 5 years after the last subject randomized
Adverse events
Time frame: Up to approximately 2 months after surgery
Change in cluster of differentiation 8 (CD8)
Time frame: At baseline to surgery
Health-related quality of life - EORTC-QLQ-C30
Time frame: Up to approximately 2 years
Residual cancer burden score
Time frame: 1 month after surgery
Change in tumor-infiltrating lymphocytes (TILs)
Time frame: At baseline to surgery
Change in programmed cell death protein L1 (PD-L1)
Time frame: At baseline to surgery
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 1 Oct 2025.
- 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.
Jianmin Fang, Ph.D study director
RemeGen Co., Ltd.
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 Disitamab Vedotin Injection, Pertuzumab Injection and Toripalimab in people with Breast Cancer, run by RemeGen Co., Ltd. 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 18 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 1 Oct 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 Jianmin Fang, Ph.D (+8610-58075763, Jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (ypT0/is ypN0) (time frame: 1 month after surgery). 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 1 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.