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HR+/HER2- Breast CancerPhase 2CISN-LNCT07254858

Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer

A Phase 2 study testing Neoadjuvant radiotherapy, Neoadjuvant Chemotherapy (NACT) and Immunotherapy (Sintilimab) in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+/HER2- breast cancer patients. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HR+/HER2- Breast Cancer
What is being tested?
Neoadjuvant radiotherapy, Neoadjuvant Chemotherapy (NACT) and Immunotherapy (Sintilimab)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
1 siteChina
Study dates
Dec 2025to 30 Dec 2029
Phase
Phase 2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, untreated breast cancer;
  • Age: 18 years ≤ age ≤ 75 years;
  • Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor [ER] ≥ 10%);
  • Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0/1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;
  • Histologically confirmed cell proliferation index (Ki67) ≥ 20%;
  • Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh/archived specimens);
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  • Good pulmonary function;
  • Adequate hepatic and renal function;
  • Histological grade ≥ 2;
  • cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);
  • Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:
  • 1.Pregnancy; 2.Tumor > 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) >3.2cm； (2) maximum heart distance(MHD) <2.4cm。

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Professor Wang, 86+13957706099, woc099@163.com

Other trials in China

About this study

Official title: Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer: A Prospective Multicenter Randomized Controlled Trial

This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+/HER2- breast cancer patients.

The study plans to enroll treatment-naïve HR+/HER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day.

Read more

The study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits.

The study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+/HER2- breast cancer patients and improve their therapeutic outcomes.

Being tested
Neoadjuvant radiotherapy, Neoadjuvant Chemotherapy (NACT), Immunotherapy (Sintilimab)
Keywords
Breast Cancer, Radiotherapy, Immunotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant radiotherapyRadiation

    Neoadjuvant Radiotherapy Regimen:

    1. Radiotherapy Technique: Stereotactic Body Radiation Therapy (SBRT) Radiation Dose and Fractionation: 8 Gy per fraction, for a total of 3 fractions, amounting to a total dose of 24 Gy
    2. Radiotherapy Schedule: Irradiation begins on the second day of the first chemotherapy cycle and is administered every other day
    3. Target Volume Definition: The radiotherapy target volume is defined based on baseline imaging (e.g., CT, MRI, or PET-CT)
    4. Radiotherapy Equipment and Planning: Treatment is delivered using a linear accelerator equipped with Image-Guided Radiotherapy (IGRT) technology to ensure precise irradiation and dose optimization

  • Neoadjuvant Chemotherapy (NACT)Drug

    Neoadjuvant Chemotherapy Regimen:

    A sequential chemotherapy strategy is adopted, with the specific regimen as follows:

    Taxane-based Chemotherapy Phase (T Phase):

    Nab-paclitaxel (125 mg/m²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles.

    Anthracycline-based Combination Chemotherapy Phase (EC Phase):

    Epirubicin (75-100 mg/m²) in combination with cyclophosphamide (600 mg/m²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles.

    The EC phase commences upon completion of the T phase.

  • Immunotherapy (Sintilimab)Drug

    Immunotherapy Regimen:

    Sintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W).

    Dosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.

Study groups in NCT07254858
Study groupRoleWhat they receive
Chemotherapy+ImmunotherapyExperimentalControl Group: Neoadjuvant chemotherapy combined with immunotherapy, wherein the neoadjuvant chemotherapy regimen follows the clinical standard protocol. Neoadjuvant Chemotherapy Regimen: A sequential chemotherapy strategy is adopted, with the specific regimen as follows: Taxane-based Chemotherapy Phase (T Phase): Nab-paclitaxel (125 mg/m²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles. Anthracycline-based Combination Chemotherapy Phase (EC Phase): Epirubicin (75-100 mg/m²) in combination with cyclophosphamide (600 mg/m²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles. The EC phase commences upon completion of the T phase. Immunotherapy Regimen: Sintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W). Dosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.
Receives: Drug: Neoadjuvant Chemotherapy (NACT); Drug: Immunotherapy (Sintilimab)
Chemotherapy + Immunotherapy + RadiotherapyExperimentalNeoadjuvant chemotherapy combined with immunotherapy（same as Arm1) + Neoadjuvant Radiotherapy
Receives: Radiation: Neoadjuvant radiotherapy; Drug: Neoadjuvant Chemotherapy (NACT); Drug: Immunotherapy (Sintilimab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate（pCR）

    Postoperative pathological assessment (tumor Miller-Payne system grading and axillary lymph node pathological assessment)

    Measured: Pathological diagnosis results were obtained tithin one month after the operation

Secondary outcomes (3)

  1. Objective response rate(ORR)

    The proportion of patients achieving complete response (CR) and partial response (PR) after tumor treatment was used as the second endpoint of the primary endpoint for hierarchical testing.

    Measured: At the end of Cycle 8 (each cycle is 28 days)

  2. Event-free survival rate

    The time from randomization to the event (recurrence, metastasis or death)

    Measured: Long-term follow-up monitoring was conducted until 3 years after enrollment

  3. Incidence of adverse reactions

    Continuous monitoring, assessment and patient feedback.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study startDec 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
302 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254858
Sponsor's protocol ID
KY2025-301
Acronym
CISN-L
Status last verified
Sep 2025
First submitted
8 Sep 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant radiotherapy, Neoadjuvant Chemotherapy (NACT) and Immunotherapy (Sintilimab) in people with HR+/HER2- Breast Cancer, run by First Affiliated Hospital of Wenzhou Medical University 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 0 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: opening soon, as of the sponsor's last update on 28 Nov 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate（pCR） (time frame: Pathological diagnosis results were obtained tithin one month after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254858.

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 28 Nov 2025.

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