Breast Neoplasms
Conditions
Keywords
breast cancer, neoadjuvant radiotherapy, biomarkers
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.
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. 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.
Interventions
RADIATIONNeoadjuvant radiotherapy
radiation therapy combined with chemotherapy prior to surgery
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Preoperative radiotherapy and concurrent chemotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fbjective response rate(ORR) | 3 year | for inoperable patients |
| Pathological response rate | 1 year | only for operable patients |
| Event free survival(EFS) | 3 year | for all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Toxicity | 6 months | using CTCAE 4.0 and RTOG classification |
| Time to progression | 3 year | including local-regional recurrence, disease-free survival, overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXiaoli Yu
Backup ContactJin Meng
Outcome results
None listed