Breast CancerNCT05132790
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
A study testing SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily and SBRT in people with Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily and SBRT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2023to 31 Dec 2028
- Phase
- Interventional
- 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
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
- ER, PR and HER2 testing, and
- TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
- ER-positive and HER2-negative breast cancer
- tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
- Any nodal status
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- ECOG Performance Status of 0 -1
- Screening laboratory values must meet the following criteria:
- Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%.
Who cannot join
- Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
- Inflammatory breast cancer
- Pregnant and lactating women;
- distant metastasis
- patients who have participated in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment for Patients With Triple-negative and Hormone Receptor-positive, HER2-negative Breast Cancer
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer
- Conditions
- Breast Cancer
- Being tested
- SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily, SBRT
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316 at a dose 20mg/kg q3wDrug
Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin
SHR6390 at a dose of 150mg orally, dailyDrug
SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT
SBRTRadiation
radiation therapy for breast cance before surgery.
| Study group | Role | What they receive |
|---|---|---|
| TNBC | Experimental | Not described Receives: Drug: SHR-1316 at a dose 20mg/kg q3w; Radiation: SBRT |
| HER2-/HR+BC | Experimental | Not described Receives: Drug: SHR6390 at a dose of 150mg orally, daily; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) for TNBC group
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Measured: Up to11 months
Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome
Measured: Up to11 months
Secondary outcomes (2)
Pathological complete response (pCR) forHER2-/HR+BC group
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Measured: Up to11 months
Residual cancer burden (RCB) 0-I index for TNBC group
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome
Measured: Up to11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132790
- Sponsor's protocol ID
- BC-NEO-IIT-SHR1316-SHR6390-RT
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Findings from this study will indicate whether stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer is safe and effective.
Publications
Zhang Y, Cao S, Niu N, Shan H, Xue J, Chen G, Xu Y, Yin J, Liu C, Sun L, Jiang X, Tang M, Xu Q, Jia M, Zhang X, Zhang Z, Zhang Q, Wang J, Li A, Yang Y, Liu C. Efficacy and safety of neoadjuvant stereotactic body radiation therapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer: A prospective pilot study. Elife. 2025 Jul 28;14:RP101583. doi: 10.7554/eLife.101583.
PubMed 40719174Chen G, Gu X, Xue J, Zhang X, Yu X, Zhang Y, Li A, Zhao Y, He G, Tang M, Xing F, Yin J, Bian X, Han Y, Cao S, Liu C, Jiang X, Zhang K, Xia Y, Li H, Niu N, Liu C; Northeastern Clinical Research Alliance of Oncology (NCRAO). Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study. Elife. 2023 Dec 22;12:e91737. doi: 10.7554/eLife.91737.
PubMed 38131294
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment for Patients With Triple-negative and Hormone Receptor-positive, HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05132790
- Acronym / sponsor ID
- BC-NEO-IIT-SHR1316-SHR6390-RT
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Nov 2021 (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 study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNBC | Experimental | Drug: SHR-1316 at a dose 20mg/kg q3w, Radiation: SBRT |
| HER2-/HR+BC | Experimental | Drug: SHR6390 at a dose of 150mg orally, daily, Radiation: SBRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
- ER, PR and HER2 testing, and
- TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
- ER-positive and HER2-negative breast cancer
- tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
Key exclusion criteria (5 listed)
- Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
- Inflammatory breast cancer
- Pregnant and lactating women;
- distant metastasis
- patients who have participated in other clinical trials.
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 |
|---|---|---|
| SHR-1316 at a dose 20mg/kg q3wCombination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin | Drug | TNBC |
| SHR6390 at a dose of 150mg orally, dailySHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT | Drug | HER2-/HR+BC |
| SBRTradiation therapy for breast cance before surgery. | Radiation | HER2-/HR+BC, TNBC |
Primary outcome
Pathological complete response (pCR) for TNBC group
Time frame: Up to11 months
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group
Time frame: Up to11 months
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome
2 secondary outcomes
Pathological complete response (pCR) forHER2-/HR+BC group
Time frame: Up to11 months
Residual cancer burden (RCB) 0-I index for TNBC group
Time frame: Up to11 months
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 3 Jan 2024.
- Derived from this study: PubMed 40719174Zhang Y, Cao S, Niu N, Shan H, Xue J, Chen G, Xu Y, Yin J, Liu C, Sun L, Jiang X, Tang M, Xu Q, Jia M, Zhang X, Zhang Z, Zhang Q, Wang J, Li A, Yang Y, Liu C. Efficacy and safety of neoadjuvant stereotactic body radiation therapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer: A prospective pilot study. Elife. 2025 Jul 28;14:RP101583. doi: 10.7554/eLife.101583.
- Derived from this study: PubMed 38131294Chen G, Gu X, Xue J, Zhang X, Yu X, Zhang Y, Li A, Zhao Y, He G, Tang M, Xing F, Yin J, Bian X, Han Y, Cao S, Liu C, Jiang X, Zhang K, Xia Y, Li H, Niu N, Liu C; Northeastern Clinical Research Alliance of Oncology (NCRAO). Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study. Elife. 2023 Dec 22;12:e91737. doi: 10.7554/eLife.91737.
- Individual participant dataSharing planned: Yes. Findings from this study will indicate whether stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer is safe and effective.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily and SBRT in people with Breast Cancer, run by Shengjing 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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) for TNBC group (time frame: Up to11 months). The study lists 2 primary outcomes in all. 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 NCT05132790, which also lists 2 linked publications.
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 3 Jan 2024.