Response-Based Local Therapy for Regionally Advanced Breast Cancer
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:
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Shulian Wang, M.D.
- Phone Number: +86-010-87787659
- Email: wangsl@cicams.ac.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Response-Adapted comprehensive treatment strategy
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-Free Survival (PFS)
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Cumulative Incidence of Locoregional Recurrence
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Cumulative Incidence of Distant Metastasis
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Incidence of Treatment-Related Toxicities
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC5176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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