Status and phase
Conditions
Treatments
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
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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;
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):
Female subjects of childbearing potential who meet the following criteria:
Male subjects of fertile potential who meet the following criteria:
Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow up procedural arrangements.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups
Loading...
Central trial contact
Changling Li
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal