Clinical trial NCT05479409: Neoadjuvant Radiation in Locally Advanced Breast Cancer
Official title: Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast cancer
neoadjuvant radiotherapy
biomarkers
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Preoperative radiotherapy and concurrent chemotherapy
Primary purpose: TREATMENT

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.

Eligibility 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
* 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.

Primary outcomes:
measure: Pathological response rate
timeFrame: 1 year
measure: Fbjective response rate(ORR)
timeFrame: 3 year
measure: Event free survival(EFS)
timeFrame: 3 year
Secondary outcomes:
measure: Time to progression
timeFrame: 3 year
measure: Radiation Toxicity
timeFrame: 6 months
Other outcomes:
measure: Biologic predictor for treatment response
timeFrame: before treatment
measure: The role of ultrasound in predicting treatment response
timeFrame: before and 1 month after treatment
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaoli Yu
role: PRINCIPAL_INVESTIGATOR
References: