Breast Cancer InvasiveNCT06781281
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
An observational study of Breast Cancer Invasive, run by Henan Cancer Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- Serplulimab and NabPE
- How many people
- 709 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to 28 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All female breast cancer patients diagnosed and scheduled to receive neoadjuvant chemotherapy
Who may be able to join
- Age>=18 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven HR+/HER2- breast cancer:
- defined as:
- 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)；
Show all 12Show fewer
- Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
- Cardiac ultrasound EF value ≧55%；
- Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
- ECOG score≤1 point;
- Sign informed consent；
Who cannot join
- 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；
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- The patient has severe lung or heart disease;
Show all 10Show fewer
- The patient has active hepatitis B and C;
- The patient has a history of organ transplantation or bone marrow transplantation;
- pregnant or breastfeeding women;
- The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast cancer-an Observational Real-world Study.
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.
Read the detailed description
In recent years, significant progress has been made in the immunotherapy of breast cancer, and PD1/PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer. There have also been many attempts to apply them in HR+/HER2- breast cancer. In the I-SPY2 study, Pembrolizumab combined with chemotherapy increased the pCR rate of HR+/HER2- breast cancer from 13% in the chemotherapy alone group to 30%. In the KEYNOTE756 study, Pembrolizumab in combination with chemotherapy increased the pCR rate by 8.5% (24.3% vs. 15.6%) compared to the chemotherapy-only arm in HR+/HER2- breast cancer. pCR rates in the nivolizumab arm of the CheckMate 7FL study were 24.5% compared with 13.8% in the control arm. While further long-term follow-up data are still needed to confirm patient benefit, it still provides a new treatment option for HR+/HER2- breast cancer patients.
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
- Conditions
- Breast Cancer Invasive
- Being tested
- Serplulimab, NabPE
- Keywords
- HR+/HER2-, PD1, Real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab
NabPEDrug
Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2
| Study group | Role | What they receive |
|---|---|---|
| NabPE+Serplulimab group | Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3, every 3 weeks for 6 cycles. Receives: Drug: Serplulimab; Drug: NabPE | |
| NabPE | Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1, every 3 weeks for 6 cycles. Receives: Drug: NabPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Measured: 24 weeks
Secondary outcomes (4)
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.
Measured: 5-10 years
DFS
Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Measured: 5-10 years
Objective Response Rate (ORR)
ORR is defined as the number of target lesion responders as assessed by MRI
Measured: 24 WEEKS
adverse events
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Measured: After each cycle of chemotherapy (21 days as 1 cycle)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start4 Dec 2024
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 709 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781281
- Sponsor's protocol ID
- HELEN-018RWS
- Status last verified
- Jun 2025
- First submitted
- 5 Dec 2024
- Last updated
- 23 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast cancer-an Observational Real-world Study.
- ClinicalTrials.gov ID
- NCT06781281
- Acronym / sponsor ID
- HELEN-018RWS
- Conditions
- Breast Cancer Invasive
- Keywords
- HR+/HER2-, PD1, Real-world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 709 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2030 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, significant progress has been made in the immunotherapy of breast cancer, and PD1/PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer. There have also been many attempts to apply them in HR+/HER2- breast cancer. In the I-SPY2 study, Pembrolizumab combined with chemotherapy increased the pCR rate of HR+/HER2- breast cancer from 13% in the chemotherapy alone group to 30%. In the KEYNOTE756 study, Pembrolizumab in combination with chemotherapy increased the pCR rate by 8.5% (24.3% vs. 15.6%) compared to the chemotherapy-only arm in HR+/HER2- breast cancer. pCR rates in the nivolizumab arm of the CheckMate 7FL study were 24.5% compared with 13.8% in the control arm. While further long-term follow-up data are still needed to confirm patient benefit, it still provides a new treatment option for HR+/HER2- breast cancer patients.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NabPE+Serplulimab group | – | Drug: Serplulimab, Drug: NabPEEpirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3, every 3 weeks for 6 cycles. |
| NabPE | – | Drug: NabPEEpirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1, every 3 weeks for 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All female breast cancer patients diagnosed and scheduled to receive neoadjuvant chemotherapy
Key inclusion criteria (12 listed)
- Age>=18 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven HR+/HER2- breast cancer:
- Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
Key exclusion criteria (10 listed)
- 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；
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerplulimabSerplulimab | Drug | NabPE+Serplulimab group |
| NabPEEpirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2 | Drug | NabPE, NabPE+Serplulimab group |
Primary outcome
pathological complete response
Time frame: 24 weeks
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
4 secondary outcomes
Event-Free Survival (EFS)
Time frame: 5-10 years
DFS
Time frame: 5-10 years
Objective Response Rate (ORR)
Time frame: 24 WEEKS
adverse events
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2025.
Related trials for Breast Cancer Invasive
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Invasive, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Liu, Dr. (13603862755, zlyyliuzhenzhen0800@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2025.