Breast Cancer InvasivePhase 2NCT06691594
Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy
A Phase 2 study testing neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in people with Breast Cancer Invasive, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Nov 2030
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to enrollment
- Age ≥ 18 years
- ECOG PS score 0-1
- Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
- Triple-negative breast cancer with PD-L1 CPS < 10
- Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L
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- BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN
- Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN
- Women of childbearing potential must be willing to use contraception during the study
- Negative serum or urine pregnancy test within 7 days prior to treatment
Who cannot join
- Occult breast cancer
- Bilateral breast cancer
- Breast tumor unsuitable for SBRT
- Unable to undergo MRI scanning
- History of other malignancies that may affect survival
- Active autoimmune disease or history of autoimmune disease
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- Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)
- Known allergy to any component of the investigational drugs
- Uncontrolled cardiac symptoms or diseases
- Active infection or unexplained fever > 38.5°C during screening/before first dose
- Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.
- Conditions
- Breast Cancer Invasive
- Being tested
- neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
- Keywords
- preoperative radiothrapy, immunotherapy, triple-negative breast cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapyRadiation
Also called radiotherapy combined with chemotherapy and immunotherapy
Eligible participants will receive neoadjuvant treatment consisting of:
SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).
Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).
Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.
Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy | Experimental | Eligible participants will receive neoadjuvant treatment consisting of:
SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).
Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).
Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.
Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year. Receives: Radiation: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment
Measured: From enrollment to the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study startFeb 2025 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691594
- Sponsor's protocol ID
- NCC4456
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06691594
- Acronym / sponsor ID
- NCC4456
- Conditions
- Breast Cancer Invasive
- Keywords
- preoperative radiothrapy, immunotherapy, triple-negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 15 Nov 2024 (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 primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy | Experimental | Radiation: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapyEligible participants will receive neoadjuvant treatment consisting of: SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor). Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5). Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response. Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent prior to enrollment
- Age ≥ 18 years
- ECOG PS score 0-1
- Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
- Triple-negative breast cancer with PD-L1 CPS < 10
Key exclusion criteria (11 listed)
- Occult breast cancer
- Bilateral breast cancer
- Breast tumor unsuitable for SBRT
- Unable to undergo MRI scanning
- History of other malignancies that may affect survival
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 |
|---|---|---|
| neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapyAlso: radiotherapy combined with chemotherapy and immunotherapyEligible participants will receive neoadjuvant treatment consisting of: SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor). Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5). Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response. Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year. | Radiation | neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy |
Primary outcome
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
Time frame: From enrollment to the completion of surgery
pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment
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 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in people with Breast Cancer Invasive, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 10 inclusion and 11 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xuran Zhao, Doctor (13661135602, 923791362@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy (time frame: From enrollment to the completion of surgery). 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 20 Feb 2025.