Neoadjuvant Radiation in Locally Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479409
• Other study ID #: FDRT-BC016
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: July 2022
• Source: Fudan University
• Contact: Xiaoli Yu
• Phone: +86-021-64175590
• Email: stephanieyxl[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Radiation:
• Neoadjuvant radiotherapy
radiation therapy combined with chemotherapy prior to surgery

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biologic predictor for treatment response	biopsies of the original tumor before treatment for future molecular biology studies in LABC	before treatment
Other	The role of ultrasound in predicting treatment response	shear wave elastography(SWE) technology	before and 1 month after treatment
Primary	Pathological response rate	only for operable patients	1 year
Primary	Fbjective response rate(ORR)	for inoperable patients	3 year
Primary	Event free survival(EFS)	for all patients	3 year
Secondary	Time to progression	including local-regional recurrence, disease-free survival, overall survival	3 year
Secondary	Radiation Toxicity	using CTCAE 4.0 and RTOG classification	6 months