Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

January 31, 2019 updated by: Jinli Ma, Fudan University

Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients

The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age≥ 50 years
  • Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
  • Negative surgical margins
  • Pathologically confirmed invasive breast cancer
  • A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
  • Tumor bed is labeled with Titanium clips
  • Received adjuvant hormonal treatment
  • No adjuvant chemotherapy
  • ECOG:0-1
  • Written informed consent.

Exclusion Criteria:

  • Age<50 years
  • KPS<70
  • Treated with neoadjuvant chemotherapy
  • Treated or being treated with chemotherapy
  • With severe comorbidity
  • Previous breast cancer or other malignant tumor history
  • Previous radiotherapy for breast or thorax
  • Medical contraindication for radiotherapy
  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HF-PBI
Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
Radiation: hypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of breast cosmetic outcome
Time Frame: Baseline, and three years after the completion of radiation therapy
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Baseline, and three years after the completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute radiation-induced toxicity assessed by CTCAE v4.0
Time Frame: 3weeks, 5weeks,1 and 3 months after treatment beginning
acute toxicity related to skin and lung
3weeks, 5weeks,1 and 3 months after treatment beginning
Late complications
Time Frame: 3 years
Complications related to radiation treatment after more than 3 months.
3 years
Ipsilateral breast tumor recurrence rate
Time Frame: 5 years
The pathological confirmed tumor recurrence in the same breast
5 years
Local-regional recurrence
Time Frame: 5 years
Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
5 years
Disease free survival
Time Frame: 5 years
The interval from diagnosis to disease recurrence or death or last visit.
5 years
Overall survival
Time Frame: 5 years
The interval from diagnosis to death or last visit
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jinli Ma, MD,PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-BC003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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