Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Iparomlimab and Tuvonralimab
Drug5.0mg/kg qw, start from C1D15
Paclitaxel
Drug80mg/m\^2 qw
Carboplatin
DrugAUC=1.5, D1, 8, 15, every 28 days
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: neoadjuvant Iparomlimab and Tuvonralimab (QL1706)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients with pCR
Number of patients with pathological complete response/Number of all eligible patients
Time frame
1-2 weeks after surgerySecondary outcomes
1
Proportion of patients with adverse events
Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients
Time frame
From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)Sponsors and contacts
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Source ClinicalTrials.gov