Neoadjuvant Radiation in Locally Advanced Breast Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Radiation: Neoadjuvant radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jin Meng; Phone Number: +86 18121299532; Email: jademj@126.com
• Study Contact Backup: Name: Xiaoli Yu; Phone Number: +86-021-64175590; Email: stephanieyxl@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xiaoli Yu; Email: stephanieyxl@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biologic predictor for treatment response	biopsies of the original tumor before treatment for future molecular biology studies in LABC	before treatment
The role of ultrasound in predicting treatment response	shear wave elastography(SWE) technology	before and 1 month after treatment

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Xiaoli Yu, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; biomarkers; neoadjuvant radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FDRT-BC016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No