Health TrialsbyHealthPanel

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

ConditionHR+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.

The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serplulimab

    Drug

    Serplulimab is administered intravenously

  • Epirubicin

    Drug

    Epirubicin ivgtt

  • Albumin Paclitaxel

    Drug

    Albumin Paclitaxel ivgtt

Treatment groups

357 Participants
are divided into 3 treatment groups
Group A: Experimental: Treatment group1Experimental treatment 3 interventions
Group B: Experimental: Treatment group2Experimental treatment 3 interventions
Group C: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PCR rate

Total pathological complete response

Time frame
At the time of surgery
2

PCR rate in PDL1 positive subgroup

Total pathological complete response

Time frame
At the time of surgery

Secondary outcomes

1

EFS

• Event-free survival (EFS)

Time frame
5-10 years
2

DFS

Disease-free survival (DFS)

Time frame
5-10 years
3

adverse events

Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0

Time frame
up to 1 year

Other outcomes

1

PCR rates in groups defined by combination of PD-L1 and stromal tumor-infiltrating lymphocytes (sTILs) status

Time frame
At the time of surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now