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New treatment option for Breast Cancer
Official title Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
ClinicalTrials.gov ID: NCT06227117
What this study is testing
What is Disitamab Vedotin Injection （18 weeks）?
Disitamab Vedotin Injection （18 weeks） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as DV,RC48-ADC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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+...
- Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear...
- Histologically confirmed invasive carcinoma of the breast according to AJCC 8th edition investigator-assessed clinical staging T1cN1-2M0, or...
You likely can't join if
- 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...
- History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation
See the full eligibility criteria
Who can 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...
- 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
- people 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;
- 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...
- 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 people 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. people with...
- 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...
- Male people 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...
- 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.
What rules you out
- 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
- 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...
- 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...
- 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...
- 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);
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Shanghai, Shanghai Municipality, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.