Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

October 23, 2018 updated by: Michele Tedeschi, Istituto Clinico Humanitas

Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 2

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

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

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

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 55< Age <70
  • Tumor size ≤ 2 cm
  • pN0 (SN biopsy or ALND)
  • ER/PgR positive
  • Margins > 5 mm (either at initial surgery or at re-excision)
  • Clips placed in the surgical bed (minimum of 4 clips)
  • Unicentric only
  • No lymphovascular invasion
  • Any grade
  • No extensive intraductal component (>25%)
  • Written informed consent

Exclusion Criteria:

  • Prior thoracic radiation therapy
  • Oncoplastic surgery / No clips in the surgical bed
  • Multicentric cancer
  • Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypofractionated WBI
Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).
Radiation: Hypofractionated WBI
Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Experimental: Accelerated Partial Breast Irradiation
Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).
Radiation: Accelerated Partial Breast Irradiation
APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity will be measured with CTCAE v.4.0
Time Frame: ten years
ten years
Cosmesis will be measured with Harvard scale
Time Frame: ten years
ten years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Local Control
Time Frame: ten years
ten years
Disease Free Survival
Time Frame: ten years
ten years
Overall Survival
Time Frame: ten years
ten years
Quality of Life Questionnaire
Time Frame: ten years
ten years

Collaborators and Investigators

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

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Marta Scorsetti, MD, Istituto Clinico Humanitas

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 (Actual)

January 19, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1288

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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