Breast CancerNCT07164872
Neoadjuvant Chemotherapy Combined With Preoperative Radiotherapy for Locally Advanced Breast Cancer
A study testing preoperative radiotherapy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
Approximately 20% of breast cancer patients in our country are in the locally advanced stage. The relatively low overall survival rate, high recurrence rate and distant metastasis risk of these patients significantly affect the therapeutic efficacy and survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- preoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2032
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pathological diagnosis was invasive breast cancer.
- cT3-4, cN1-2, M0 (according to the 8th edition of the AJCC Cancer Staging Manual), molecular typing is Luminal type (HER2-) or triple-negative type. The volume of the primary lesion did not decrease by more than 50% after 2 cycles of neoadjuvant chemotherapy.
- Generally in good condition (KPS score > 70), organ functions are tolerable, and there are no severe complications due to poor control.
- Acceptable for magnetic resonance imaging scan
- Have the conditions for follow-up
- Sign the informed consent form
Who cannot join
- gestation period
- Simultaneous bilateral breast cancer
- History of chest wall radiotherapy
- Active connective tissue disease
- Inflammatory breast cancer
- Excessive breast volume (>600ml), BMI > 30
Show all 9Show fewer
- diabetes
- Positive lymph nodes in the upper and lower regions of the clavicle and the internal mammary region
- Using immunotherapy drugs such as PD-1/PD-L1
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
Approximately 20% of breast cancer patients in our country are in the locally advanced stage. The relatively low overall survival rate, high recurrence rate and distant metastasis risk of these patients significantly affect the therapeutic efficacy and survival. Preoperative radiotherapy is a treatment option for many tumors. It is recommended to administer radiotherapy and systemic chemotherapy before surgery to enhance preoperative tumor downstaging, eliminate micrometastatic lesions and improve overall survival rate. Preoperative radiotherapy combined with chemotherapy for breast cancer patients further shrinks the tumor, increases the probability of breast preservation, and may also eliminate the need for axillary lymph node dissection, thereby improving the quality of life of patients. Pathological complete response (pCR) not only helps with subsequent surgery but also has significant advantages in improving survival rate. Neoadjuvant radiotherapy is also one of the treatment options for reducing tumor stage, but it has not been widely applied to breast cancer patients. Among breast cancer subtypes, Luminal type accounts for 50-70%, among which HR+ HER2- breast cancer patients have poor efficacy from neoadjuvant chemotherapy and pCR rate is below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes. It has the characteristics of poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit. This study aims to explore the efficacy and safety of neoadjuvant radiotherapy for locally advanced breast cancer.
Read the detailed description
Approximately one fifth of the patients in China have non-metastatic locally advanced breast cancer. Due to their relatively low overall survival rate, high recurrence rate, and risk of distant metastasis, this significantly affects the therapeutic efficacy and survival of the patients. Preoperative neoadjuvant radiotherapy is a common treatment option for many tumors (such as esophageal cancer, rectal cancer, soft tissue sarcoma, etc.), by advancing radiotherapy and systemic chemotherapy to before surgery to enhance preoperative treatment for tumor downstaging and early elimination of micrometastatic lesions to improve overall survival rate. In breast cancer patients, preoperative radiotherapy combined with chemotherapy has the opportunity to further shrink the tumor, increase the probability of breast preservation, and possibly avoid axillary lymph node dissection, thereby improving the quality of life of the patients. Pathological complete response (pCR) not only helps subsequent surgical treatment but also has significant advantages in improving survival rate, significantly improving the overall prognosis of patients. Neoadjuvant radiotherapy is also one of the treatment options for reducing the stage. However, this combination has not been widely applied to breast cancer patients yet and further clinical research is needed. Among all breast cancers, Luminal-type breast cancer accounts for 50-70%, among which patients with HR+HER2- type breast cancer have poor efficacy of neoadjuvant chemotherapy and the pCR rate is usually below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes, characterized by poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit and the pCR rate hovers around 35%. This study aims to explore the pCR rate, effectiveness and safety of preoperative chemotherapy combined with preoperative medium-dose fractionated radiotherapy in patients with locally advanced HR+HER2- type and triple-negative breast cancer, to improve the overall survival of these patients.
- Conditions
- Breast Cancer
- Being tested
- preoperative radiotherapy
- Keywords
- breast cancer; preoperative radiotherapy; pCR
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative radiotherapyRadiation
preoperative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| preoperative radiotherapy | Experimental | whole breast irradiation of the affected side ± chest wall + regional lymph node drainage area irradiation: whole breast ± chest wall + supraclavicular and internal mammary regional lymph node drainage area 40.05Gy/152.67Gy/ day per session, axillary regional lymph node drainage area 37.5Gy/15f,2.5Gy/ per session Receives: Radiation: preoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete respons
pathological complete
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164872
- Sponsor's protocol ID
- JS2025-6-1
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Combined With Preoperative Radiotherapy for Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07164872
- Acronym / sponsor ID
- JS2025-6-1
- Conditions
- Breast Cancer
- Keywords
- breast cancer; preoperative radiotherapy; pCR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 10 Sep 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.
Approximately 20% of breast cancer patients in our country are in the locally advanced stage. The relatively low overall survival rate, high recurrence rate and distant metastasis risk of these patients significantly affect the therapeutic efficacy and survival. Preoperative radiotherapy is a treatment option for many tumors. It is recommended to administer radiotherapy and systemic chemotherapy before surgery to enhance preoperative tumor downstaging, eliminate micrometastatic lesions and improve overall survival rate. Preoperative radiotherapy combined with chemotherapy for breast cancer patients further shrinks the tumor, increases the probability of breast preservation, and may also eliminate the need for axillary lymph node dissection, thereby improving the quality of life of patients. Pathological complete response (pCR) not only helps with subsequent surgery but also has significant advantages in improving survival rate. Neoadjuvant radiotherapy is also one of the treatment options for reducing tumor stage, but it has not been widely applied to breast cancer patients. Among breast cancer subtypes, Luminal type accounts for 50-70%, among which HR+ HER2- breast cancer patients have poor efficacy from neoadjuvant chemotherapy and pCR rate is below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes. It has the characteristics of poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit. This study aims to explore the efficacy and safety of neoadjuvant radiotherapy for locally advanced breast cancer.
Detailed description
Approximately one fifth of the patients in China have non-metastatic locally advanced breast cancer. Due to their relatively low overall survival rate, high recurrence rate, and risk of distant metastasis, this significantly affects the therapeutic efficacy and survival of the patients. Preoperative neoadjuvant radiotherapy is a common treatment option for many tumors (such as esophageal cancer, rectal cancer, soft tissue sarcoma, etc.), by advancing radiotherapy and systemic chemotherapy to before surgery to enhance preoperative treatment for tumor downstaging and early elimination of micrometastatic lesions to improve overall survival rate. In breast cancer patients, preoperative radiotherapy combined with chemotherapy has the opportunity to further shrink the tumor, increase the probability of breast preservation, and possibly avoid axillary lymph node dissection, thereby improving the quality of life of the patients. Pathological complete response (pCR) not only helps subsequent surgical treatment but also has significant advantages in improving survival rate, significantly improving the overall prognosis of patients. Neoadjuvant radiotherapy is also one of the treatment options for reducing the stage. However, this combination has not been widely applied to breast cancer patients yet and further clinical research is needed. Among all breast cancers, Luminal-type breast cancer accounts for 50-70%, among which patients with HR+HER2- type breast cancer have poor efficacy of neoadjuvant chemotherapy and the pCR rate is usually below 5-10%. Triple-negative breast cancer accounts for 15-20% of all breast cancer subtypes, characterized by poor differentiation, strong invasiveness, earlier and more frequent recurrence and metastasis. The efficacy of traditional neoadjuvant chemotherapy has approached its limit and the pCR rate hovers around 35%. This study aims to explore the pCR rate, effectiveness and safety of preoperative chemotherapy combined with preoperative medium-dose fractionated radiotherapy in patients with locally advanced HR+HER2- type and triple-negative breast cancer, to improve the overall survival of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative radiotherapy | Experimental | Radiation: preoperative radiotherapywhole breast irradiation of the affected side ± chest wall + regional lymph node drainage area irradiation: whole breast ± chest wall + supraclavicular and internal mammary regional lymph node drainage area 40.05Gy/152.67Gy/ day per session, axillary regional lymph node drainage area 37.5Gy/15f,2.5Gy/ per session |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The pathological diagnosis was invasive breast cancer.
- cT3-4, cN1-2, M0 (according to the 8th edition of the AJCC Cancer Staging Manual), molecular typing is Luminal type (HER2-) or triple-negative type. The volume of the primary lesion did not decrease by more than 50% after 2 cycles of neoadjuvant chemotherapy.
- Generally in good condition (KPS score > 70), organ functions are tolerable, and there are no severe complications due to poor control.
- Acceptable for magnetic resonance imaging scan
- Have the conditions for follow-up
Key exclusion criteria (9 listed)
- gestation period
- Simultaneous bilateral breast cancer
- History of chest wall radiotherapy
- Active connective tissue disease
- Inflammatory breast cancer
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 |
|---|---|---|
| preoperative radiotherapypreoperative radiotherapy | Radiation | preoperative radiotherapy |
Primary outcome
pathological complete respons
Time frame: 8-12 weeks
pathological complete
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 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Jing Jin principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing preoperative radiotherapy in people with Breast Cancer, 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 6 inclusion and 9 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 10 Sep 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.
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 Yutong Tan (+86-18674776996, yttan1231@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete respons (time frame: 8-12 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 10 Sep 2025.