Actively Recruiting
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
Led by RemeGen Co., Ltd. · Updated on 2024-03-19
120
Participants Needed
5
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent
- Age 18 years or older
- Invasive breast tumor with low HER2 expression confirmed by central lab
- Hormone receptor-negative tumor (ER and PgR less than 1%)
- Invasive breast cancer stage T1cN1-2M0 or T2-3N0-2M0
- Scheduled for radical breast cancer surgery without prior anti-tumor systemic therapy
- ECOG performance status 0 or 1
- At least one measurable lesion by RECIST v1.1
- Cardiac function NYHA class less than 3 and left ventricular ejection fraction 55% or higher
- Adequate bone marrow and organ function within 7 days prior to dosing
- Female participants of childbearing potential must have negative pregnancy test and agree to contraception and breastfeeding restrictions
- Male participants of fertile potential must agree to sperm donation restrictions and contraception
- Able to understand and comply with trial procedures
You will not qualify if you...
- Bilateral invasive breast cancer
- Previous invasive breast cancer
- Previous carcinoma in situ with endocrine therapy within 5 years
- Use of investigational drugs or major surgery within 4 weeks before study
- Live or attenuated vaccine within 4 weeks before or planned during study
- History of allogeneic stem cell or organ transplantation
- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors or antibody-coupled drugs
- Uncontrolled or significant cardiovascular disease within 6 months
- History of interstitial lung disease or severe lung disease
- Active infection requiring systemic treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of neurological or psychiatric disorder including epilepsy or dementia
- Ongoing grade 2 or higher sensory or motor neuropathy
- Serious concomitant disease affecting safety or study completion
- Positive HIV or active hepatitis B, C, or persistent COVID-19 infection
- Known hypersensitivity to study drugs or related compounds
- Other malignancy within 5 years except certain treated cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
4
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
5
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
Research Team
C
Changling Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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