QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:
Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
QL1706
Drugbispecific antibody targeting PD-1 and CLTA-4
Nab-PE
DrugNab-paclitaxel+Epirubicin
Treatment groups
238 Participants
are divided into 2 treatment groupsGroup A: QL1706 groupExperimental treatment 2 interventions
Group B: NabPE groupActive comparator 0 interventions
Trial outcomes
Primary outcomes
1
pathological complete response
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Time frame
up to 24 weeks2
pathological complete response in PDL1 positive subgroup
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Time frame
up to 24 weeksSecondary outcomes
1
Event-Free Survival (EFS)
Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Time frame
5-10 years2
Objective Response Rate (ORR)
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
Time frame
up to 24 weeks3
adverse events
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Time frame
up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov