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NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

ConditionBreast Cancer Invasive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are:

Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.

Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age>=18 years old

cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；

positive for ER or PR (IHC nuclear staining >1%)

Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；

Disqualifiers

The patient has evidence of metastatic breast cancer；

For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;

The patient has a second primary malignancy other than adequately treated skin cancer;

The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；

Trial population

All female breast cancer patients diagnosed and scheduled to receive neoadjuvant chemotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serplulimab

    Drug

    Serplulimab

  • NabPE

    Drug

    Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2

Treatment groups

709 Participants
are divided into 2 treatment groups
Group A: NabPE+Serplulimab group2 interventions
Group B: NabPE1 intervention

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
24 weeks

Secondary outcomes

1

Event-Free Survival (EFS)

EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.

Time frame
5-10 years
2

DFS

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 years
3

Objective Response Rate (ORR)

ORR is defined as the number of target lesion responders as assessed by MRI

Time frame
24 WEEKS
4

adverse events

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

Time frame
After each cycle of chemotherapy (21 days as 1 cycle)]

Other outcomes

Sponsors and contacts

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

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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