Breast CancerPhase 2NCT06227117
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
A Phase 2 study testing Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks） and Carboplatin in people with Breast Cancer, run by RemeGen Co., Ltd. at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing 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 （18 weeks）, Toripalimab （18weeks） and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesChina
- Study dates
- 27 Jul 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;
- Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC 2+ with no amplification by in situ hybridisation (ISH) (according to the Breast Cancer HER2 Detection Guidelines, 2019 edition) by immunohistochemistry; and specimens from the primary site of the tumour for HER2 detection (wax blocks, biopsies, or fresh tissues are acceptable) are available for HER2 detection
- Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of <1% according to ASCO/CAP guideline 2020;
- Histologically confirmed invasive carcinoma of the breast according to AJCC 8th edition investigator-assessed clinical staging T1cN1-2M0, or T2-3N0-2M0
- 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 the research centre;
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- ECOG PS 0 or 1 point
- At least one measurable lesion according to RECIST v1.1 criteria;
- 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;
- Creatinine Clearance (CrCl) ≥ 60 mL/min according to the Cockcroft-Gault formula method;
- Female 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 .
- 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 .
- 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
- Male subjects of fertile potential who meet the following criteria:
- It is necessary to agree not to donate sperm from the time of signing the informed consent form until at least 4 months after the last dose of study drug.
- If sexual intercourse with a person of childbearing potential is likely to result in pregnancy, continuous use of at least 2 acceptable contraceptives, at least 1 of which must be highly effective, beginning at the time of informed consent and continuing until at least 4 months after the last dose of study drug. Beginning at the time of informed consent and continuing for at least 4 months after the last dose of study drug.
- If sex with a pregnant or breastfeeding patient, condom use must be continuous from the time of informed consent and continue until at least 4 months after the last dose of study drug.
- 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
- Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
- Live or live attenuated vaccine administered within 4 weeks prior to the start of study drug administration or planned to be administered during the study period
- History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation
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- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs;
- 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;
- Ongoing active infection that requires systemic treatment;
- Have an active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of corticosteroids or immunosuppressive drugs, etc.), allowing for relevant replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency)
- A clear past or present history of a neurological or psychiatric disorder, including epilepsy or dementia
- Ongoing grade ≥2 sensory or motor neuropathy;
- Concomitant disease that, in the investigator's judgement, is a serious hazard to the subject's safety or interferes with the subject's ability to complete the clinical study;
- Positive HIV test results; patients with active hepatitis B or C (HBsAg positivity accompanied by HBV DNA titres above the upper limit of normal; HCVAb positivity accompanied by HCV RNA titres above the upper limit of normal); and persistent coronavirus (COVID-19) infection.
- Hypersensitivity reactions or delayed hypersensitivity reactions to components of Disitamab Vedotin and Toripalimab or analogues are known;
- Known hypersensitivity or delayed hypersensitivity to epirubicin, cyclophosphamide, carboplatin preparations or components or similar drugs;
- Other malignancy within 5 years prior to signing the informed consent (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumours that have been effectively treated and are considered cured);
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Juan Huang, M.D
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Quzhang Ouyang, M.D
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Yang Yu, M.D
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhimin Shao, M.D.
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jin Zhang, M.D
About this study
Official title: A Randomized, Multicenter, Open-Label Phase II Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination Toripalimab or Sequence Chemotherapy in Participants With HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
Read the detailed description
This is an open-label, randomized, multicenter, Phase II Neoadjuvant Therapy Study designed to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HR-negative, HER2 low-expressing breast cancer, by assessment of tpCR and EFS.
- Conditions
- Breast Cancer
- Being tested
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin, Disitamab Vedotin Injection （12 weeks）, Sequential Epirubicin
- Keywords
- Breast Cancer, HR-negative, HER2 low-expressing
- 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 Injection （18 weeks）Drug
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.
Toripalimab （18weeks）Drug
Also called JS001
3.0 mg/kg, intravenous infusion, D1, every 2 weeks
CarboplatinDrug
AUC 3 Q2W or AUC1.5 QW intravenous infusion
Disitamab Vedotin Injection （12 weeks）Drug
Also called DV,RC48-ADC
2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.
Sequential EpirubicinDrug
Also called Epirubicin
According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.
Sequential CTXDrug
Also called CTX, cyclophosphamide
According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.
Toripalimab （12weeks）Drug
Also called JS001
3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin + Toripalimab | Experimental | Disitamab Vedotin with Toripalimab Arm Receives: Drug: Disitamab Vedotin Injection （18 weeks）; Drug: Toripalimab （18weeks） |
| Disitamab Vedotin + Toripalimab+Carboplatin | Experimental | Disitamab Vedotin + Toripalimab with Carboplatin Arm Receives: Drug: Disitamab Vedotin Injection （18 weeks）; Drug: Toripalimab （18weeks）; Drug: Carboplatin |
| Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab | Experimental | Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX with Toripalimab Arm Receives: Drug: Disitamab Vedotin Injection （12 weeks）; Drug: Sequential Epirubicin; Drug: Sequential CTX; Drug: Toripalimab （12weeks） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (tpCR) rate (ypT0/Tis ypN0)
Defined as the proportion of participants with a pathological assessment of pCR (ypTO/Tis, ypNO) in the analyzed population;
Measured: 1 month after surgery
Secondary outcomes (11)
Breast pathological complete response（bpCR）
Defined as the proportion of participants with a pathological assessment of bpCR in the analyzed population
Measured: 1 month after surgery
Objective remission rate (ORR)
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Measured: Baseline to surgery
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 3 or 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 3 or 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 posted26 Jan 2024
- Study start27 Jul 2023
- Primary completionDec 2025 (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.
- More trials run by RemeGen Co., Ltd.The 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changling Li, Study director, RemeGen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227117
- Sponsor's protocol ID
- RC48-C024
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 19 Mar 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label Phase II Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination Toripalimab or Sequence Chemotherapy in Participants With HR-negative, HER2 Low-expressing Breast Cancer
- ClinicalTrials.gov ID
- NCT06227117
- Acronym / sponsor ID
- RC48-C024
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, HR-negative, HER2 low-expressing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 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 purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
Detailed description
This is an open-label, randomized, multicenter, Phase II Neoadjuvant Therapy Study designed to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HR-negative, HER2 low-expressing breast cancer, by assessment of tpCR and EFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin + Toripalimab | Experimental | Drug: Disitamab Vedotin Injection （18 weeks）, Drug: Toripalimab （18weeks）Disitamab Vedotin with Toripalimab Arm |
| Disitamab Vedotin + Toripalimab+Carboplatin | Experimental | Drug: Disitamab Vedotin Injection （18 weeks）, Drug: Toripalimab （18weeks）, Drug: CarboplatinDisitamab Vedotin + Toripalimab with Carboplatin Arm |
| Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab | Experimental | Drug: Disitamab Vedotin Injection （12 weeks）, Drug: Sequential Epirubicin, Drug: Sequential CTX, Drug: Toripalimab （12weeks）Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX with Toripalimab Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Voluntarily participate and sign the informed consent form;
- Ages≥18 years;
- Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC 2+ with no amplification by in situ hybridisation (ISH) (according to the Breast Cancer HER2 Detection Guidelines, 2019 edition) by immunohistochemistry; and specimens from the primary site of the tumour for HER2 detection (wax blocks, biopsies, or fresh tissues are acceptable) are available for HER2 detection
- Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of <1% according to ASCO/CAP guideline 2020;
- Histologically confirmed invasive carcinoma of the breast according to AJCC 8th edition investigator-assessed clinical staging T1cN1-2M0, or T2-3N0-2M0
Key exclusion criteria (18 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
- Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
- Live or live attenuated vaccine administered within 4 weeks prior to the start of study drug administration or planned to be administered during the study period
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 Injection （18 weeks）Also: 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 + Toripalimab, Disitamab Vedotin + Toripalimab+Carboplatin |
| Toripalimab （18weeks）Also: JS0013.0 mg/kg, intravenous infusion, D1, every 2 weeks | Drug | Disitamab Vedotin + Toripalimab, Disitamab Vedotin + Toripalimab+Carboplatin |
| CarboplatinAUC 3 Q2W or AUC1.5 QW intravenous infusion | Drug | Disitamab Vedotin + Toripalimab+Carboplatin |
| Disitamab Vedotin Injection （12 weeks）Also: DV,RC48-ADC2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. | Drug | Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab |
| Sequential EpirubicinAlso: EpirubicinAccording to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed. | Drug | Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab |
| Sequential CTXAlso: CTX, cyclophosphamideAccording to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed. | Drug | Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab |
| Toripalimab （12weeks）Also: JS0013.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. | Drug | Disitamab Vedotin + Toripalimab sequential Epirubicin+ CTX+ Toripalimab |
Primary outcome
Total pathological complete response (tpCR) rate (ypT0/Tis ypN0)
Time frame: 1 month after surgery
Defined as the proportion of participants with a pathological assessment of pCR (ypTO/Tis, ypNO) in the analyzed population;
11 secondary outcomes
Breast pathological complete response（bpCR）
Time frame: 1 month after surgery
Objective remission rate (ORR)
Time frame: Baseline to surgery
Disease free survival（DFS）
Time frame: Up to approximately 3 or 5 years
Event free survival (EFS)
Time frame: Up to approximately 3 or 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 19 Mar 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.
Changling Li study director
RemeGen Co., Ltd.
5 sites 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 （18 weeks）, Toripalimab （18weeks） and Carboplatin in people with Breast Cancer, run by RemeGen Co., Ltd. at 5 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 27 inclusion and 18 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 Changling Li (+8610-58075763, changling.li@remegen.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) rate (ypT0/Tis 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 19 Mar 2024.