Neoadjuvant Radiation in Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether neoadjuvant radiation therapy is effective in improving local-regional control and to explore predictors of response to treatment in inoperable breast cancer patients after 2-6 courses of neoadjuvant chemotherapy.

Detailed Description
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RATIONALE: The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. It is currently accepted that the administration of radiation therapy prior to surgery might result in higher surgery rate or improvement of clinical outcomes. OUTLINE： This is a prospective phase II study. The purpose is to evaluate the effectiveness of neoadjuvant radiotherapy in combination with chemotherapy. The primary objective in this study is to assess clinical outcomes of these patients. A secondary objective in this study is to identify biomarkers and imaging parameters that can be used as early predictors of treatment response in women with locally advanced breast cancer. Fresh tumor tissue or fresh peripheral blood should be collected as the test sample and stored before treatment. Ultrasound spectroscopy including shear wave elastography parameters should be done before and after treatment.

Official Title
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Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Radiation: Neoadjuvant radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed locally advanced breast carcinoma Inoperable with with 4-6 courses of prior chemotherapy No contradiction of radiation or chemo-radiotherapy Patients should have the ability to understand and the willingness to sign a written informed consent document Signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS Coagulation disorders Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia Serious underlying medical illness with life expectancy less than 2 years. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Preoperative radiotherapy and concurrent chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant radiotherapy<br>Group 1:Patients undergo mastectomy or Breast conserving surgery after radiotherapy Group 2:Patients receive boost in the area of residual breast mass and regional lymph node. A total dose of 66Gy will be given. | Radiation: Neoadjuvant radiotherapy<br>* radiation therapy combined with chemotherapy prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response rate | only for operable patients | 1 year | 
| Fbjective response rate(ORR) | for inoperable patients | 3 year | 
| Event free survival(EFS) | for all patients | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | including local-regional recurrence, disease-free survival, overall survival | 3 year | 
| Radiation Toxicity | using CTCAE 4.0 and RTOG classification | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant radiotherapy, biomarkers