Neoadjuvant Radiation in Locally Advanced Breast Cancer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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.
OUTLINEļ¼ 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Neoadjuvant radiotherapy 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
radiation therapy combined with chemotherapy prior to surgery
|
Outcome Measures
Primary Outcome Measures
- Pathological response rate [1 year]
only for operable patients
- Fbjective response rate(ORR) [3 year]
for inoperable patients
- Event free survival(EFS) [3 year]
for all patients
Secondary Outcome Measures
- Time to progression [3 year]
including local-regional recurrence, disease-free survival, overall survival
- Radiation Toxicity [6 months]
using CTCAE 4.0 and RTOG classification
Other Outcome Measures
- Biologic predictor for treatment response [before treatment]
biopsies of the original tumor before treatment for future molecular biology studies in LABC
- The role of ultrasound in predicting treatment response [before and 1 month after treatment]
shear wave elastography(SWE) technology
Eligibility Criteria
Criteria
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
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Serious underlying medical illness with life expectancy less than 2 years.
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Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Xiaoli Yu, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FDRT-BC016