Breast CancerPhase 2NCT07376538
Response-Based Local Therapy for Regionally Advanced Breast Cancer
A Phase 2 study testing Response-adapted comprehensive treatment strategy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary… 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?
- Response-adapted comprehensive treatment strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Feb 2033
- 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
- Female patients aged 18 to 75 years.
- ECOG performance status ≤ 2.
- Histologically confirmed invasive breast cancer.
- Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable.
- Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection.
- Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN.
- Able and willing to comply with study procedures and scheduled follow-up.
- Written informed consent obtained prior to any study-related procedures.
Who cannot join
- Evidence of distant metastatic disease.
- Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.
- Prior radiotherapy to the chest wall or supraclavicular region.
- Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy.
- History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.
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, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Shulian Wang, M.D., +86-010-87787659, wangsl@cicams.ac.cn
About this study
Official title: A Prospective Phase II Clinical Study of Response-Based Local Therapy After Systemic Therapy in Regionally Advanced Breast Cancer
The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN).
The main questions it aims to answer are:
Read more
Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment?
Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment?
How effective is intensified systemic therapy when tailored to the patient's molecular subtype?
- Conditions
- Breast Cancer
- Being tested
- Response-adapted comprehensive treatment strategy
- Keywords
- Regionally Advanced Breast Cancer, Hypofractionated Radiotherapy, Systemic Consolidation Therapy, Breast Surgery, Regional Lymph Node Dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response-adapted comprehensive treatment strategyRadiation
Participants will receive a response-adapted comprehensive treatment strategy following neoadjuvant systemic therapy (NST). The strategy includes:
Surgery: Patients with residual ISLN/IMLN ≥ 0.5 cm after NST are assigned (1:1) to receive either regional lymph node dissection or no dissection, in addition to standard breast and axillary surgery.
Radiotherapy: Patients receive individualized, dose-adaptive hypofractionated or conventional fractionation radiotherapy guided by the response of the breast and regional nodes to NST.
Systemic Therapy: Intensified consolidation systemic therapy is administered based on NST efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Response-Adapted comprehensive treatment strategy | Experimental | Not described Receives: Radiation: Response-adapted comprehensive treatment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: Up to 5 years
Secondary outcomes (4)
Overall Survival (OS)
Measured: Up to 5 years
Cumulative Incidence of Locoregional Recurrence
Measured: Up to 5 years
Cumulative Incidence of Distant Metastasis
Measured: Up to 5 years
Incidence of Treatment-Related Toxicities
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2033 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376538
- Sponsor's protocol ID
- NCC5176
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 11 Feb 2026
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Study of Response-Based Local Therapy After Systemic Therapy in Regionally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07376538
- Acronym / sponsor ID
- NCC5176
- Conditions
- Breast Cancer
- Keywords
- Regionally Advanced Breast Cancer, Hypofractionated Radiotherapy, Systemic Consolidation Therapy, Breast Surgery, Regional Lymph Node Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 29 Jan 2026 (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 interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN).
The main questions it aims to answer are:
Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment?
Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment?
How effective is intensified systemic therapy when tailored to the patient's molecular subtype?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Response-Adapted comprehensive treatment strategy | Experimental | Radiation: Response-adapted comprehensive treatment strategy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 18 to 75 years.
- ECOG performance status ≤ 2.
- Histologically confirmed invasive breast cancer.
- Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable.
- Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection.
Key exclusion criteria (5 listed)
- Evidence of distant metastatic disease.
- Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.
- Prior radiotherapy to the chest wall or supraclavicular region.
- Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy.
- History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.
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 |
|---|---|---|
| Response-adapted comprehensive treatment strategyParticipants will receive a response-adapted comprehensive treatment strategy following neoadjuvant systemic therapy (NST). The strategy includes: Surgery: Patients with residual ISLN/IMLN ≥ 0.5 cm after NST are assigned (1:1) to receive either regional lymph node dissection or no dissection, in addition to standard breast and axillary surgery. Radiotherapy: Patients receive individualized, dose-adaptive hypofractionated or conventional fractionation radiotherapy guided by the response of the breast and regional nodes to NST. Systemic Therapy: Intensified consolidation systemic therapy is administered based on NST efficacy. | Radiation | Response-Adapted comprehensive treatment strategy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 5 years
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years
Cumulative Incidence of Locoregional Recurrence
Time frame: Up to 5 years
Cumulative Incidence of Distant Metastasis
Time frame: Up to 5 years
Incidence of Treatment-Related Toxicities
Time frame: Up to 5 years
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 11 Feb 2026.
- 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.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Response-adapted comprehensive treatment strategy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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?
Progression-Free Survival (PFS) (time frame: Up to 5 years). 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 11 Feb 2026.