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

Primary Purpose

Cancer of Breast

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hypofractionated WBI
Accelerated Partial Breast Irradiation
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Breast

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hypofractionated WBI

Accelerated Partial Breast Irradiation

Arm Description

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).

Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).

Outcomes

Primary Outcome Measures

Toxicity will be measured with CTCAE v.4.0
Cosmesis will be measured with Harvard scale

Secondary Outcome Measures

Rate of Local Control
Disease Free Survival
Overall Survival
Quality of Life Questionnaire

Full Information

First Posted
February 13, 2015
Last Updated
October 23, 2018
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02375048
Brief Title
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
Official Title
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
number of enrollments not reached in the estimated time
Study Start Date
January 19, 2015 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated WBI
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Accelerated Partial Breast Irradiation
Arm Type
Experimental
Arm Description
Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated WBI
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Accelerated Partial Breast Irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Toxicity will be measured with CTCAE v.4.0
Time Frame
ten years
Title
Cosmesis will be measured with Harvard scale
Time Frame
ten years
Secondary Outcome Measure Information:
Title
Rate of Local Control
Time Frame
ten years
Title
Disease Free Survival
Time Frame
ten years
Title
Overall Survival
Time Frame
ten years
Title
Quality of Life Questionnaire
Time Frame
ten years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Scorsetti, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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

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