New study tailors surgery and radiation to each Patient's response in advanced breast cancer
NCT ID NCT07376538
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for women with advanced breast cancer that has spread to nearby lymph nodes. After initial chemotherapy, doctors will adjust the next steps—surgery and radiation—based on how much cancer remains. The goal is to see if this personalized approach can help people live longer without the cancer coming back. About 157 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- response-adapted radiation and surgery
- What this could lead to
- If successful, this could lead to more personalized, effective treatment for advanced breast cancer, potentially improving survival and reducing unnecessary procedures.
- What could go wrong
- This is a phase 2 trial with only 157 participants, so results may not apply to everyone. The approach is complex and may not improve outcomes or could cause side effects from intensified therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 157 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100021, China
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