Actively Recruiting
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
Led by RemeGen Co., Ltd. · Updated on 2024-05-23
79
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
CONDITIONS
Official Title
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older
- Histologically confirmed invasive breast cancer with clinical stage T1c-T2 (≥2cm) cN1-2M0 or T3cN0-2M0
- Able to tolerate and plan to undergo radical surgery for breast cancer without prior anti-tumor systemic therapy
- Low HER2 expression in tumor tissue confirmed by central lab as IHC 1+ or IHC 2+ without ISH amplification
- Tumor tissue estrogen receptor (ER) and progesterone receptor (PgR) expression ≥ 1%
- Histological grade G3 or G2 with ER expression
- ECOG physical status 0 or 1
- At least one measurable lesion per RECIST v1.1
- Heart function NYHA Grade < 3 and left ventricular ejection fraction ≥ 50%
- Bone marrow and organ function within specified limits including hemoglobin ≥ 90g/L, ANC ≥ 1.5×10⁹/L, platelet ≥100×10⁹/L, and appropriate liver and kidney function
- Fertile female subjects must have negative pregnancy test, agree to contraception during and 6 months after treatment, avoid breastfeeding and egg donation
- Fertile male subjects must agree to contraception during and 4 months after treatment, and avoid sperm donation
- Able to understand and willing to follow trial and follow-up procedures
You will not qualify if you...
- Bilateral invasive breast cancer
- Previous history of invasive breast cancer
- Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years
- Use of investigational drug or major surgery within 4 weeks before dosing
- Receipt or planned receipt of live or attenuated vaccine within 4 weeks before dosing
- Previous allogeneic hematopoietic stem cell or organ transplantation
- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors or antibody-drug conjugates
- Uncontrolled or significant cardiovascular and cerebrovascular diseases
- Other serious lung diseases including active tuberculosis or interstitial lung disease
- Active infection requiring systemic treatment
- Active autoimmune diseases needing systemic therapy within past 2 years
- History of neurological or psychiatric disorders including epilepsy or dementia
- Persistent grade ≥ 2 sensory or motor neuropathy
- Serious concomitant diseases affecting safety or study completion
- Positive HIV test, active hepatitis B or C, or persistent COVID-19 infection
- Known hypersensitivity to study drugs or similar agents
- Another malignancy within 5 years prior to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiong Wu
Shanghai, Fudan University Shanghai Cancer Center, China, 200032
Actively Recruiting
Research Team
L
Leng Kang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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