Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Conditions
Brief summary
This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
Interventions
5.0mg/kg qw, start from C1D15
DRUGPaclitaxel
80mg/m\^2 qw
DRUGCarboplatin
AUC=1.5, D1, 8, 15, every 28 days
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years * Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer * Subjects with at least one evaluable lesion * ECOG 0-1 * Adequate organ function
Exclusion criteria
* Metastatic disease (Stage IV) * Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with pCR | 1-2 weeks after surgery | Number of patients with pathological complete response/Number of all eligible patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with adverse events | From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year) | Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients |
Countries
China
Contacts
CONTACTWenjin Yin
PRINCIPAL_INVESTIGATORWenjin Yin
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed