Neoadjuvant Radiation in Locally Advanced Breast Cancer

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05479409
Collaborator
(none)
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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
  • Radiation: Neoadjuvant radiotherapy
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.

OUTLINEļ¼š 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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Preoperative radiotherapy and concurrent chemotherapyPreoperative radiotherapy and concurrent chemotherapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

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

  1. Pathological response rate [1 year]

    only for operable patients

  2. Fbjective response rate(ORR) [3 year]

    for inoperable patients

  3. Event free survival(EFS) [3 year]

    for all patients

Secondary Outcome Measures

  1. Time to progression [3 year]

    including local-regional recurrence, disease-free survival, overall survival

  2. Radiation Toxicity [6 months]

    using CTCAE 4.0 and RTOG classification

Other Outcome Measures

  1. Biologic predictor for treatment response [before treatment]

    biopsies of the original tumor before treatment for future molecular biology studies in LABC

  2. The role of ultrasound in predicting treatment response [before and 1 month after treatment]

    shear wave elastography(SWE) technology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts 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.

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.
Responsible Party:
Xiaoli Yu, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT05479409
Other Study ID Numbers:
  • FDRT-BC016
First Posted:
Jul 29, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaoli Yu, Professor, Fudan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022