NCT02375048

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

February 13, 2015

Last Update Submit

October 23, 2018

Conditions

Cancer of Breast

Outcome Measures

Primary Outcomes (2)

  • Toxicity will be measured with CTCAE v.4.0

    ten years

  • Cosmesis will be measured with Harvard scale

    ten years

Secondary Outcomes (4)

  • Rate of Local Control

    ten years

  • Disease Free Survival

    ten years

  • Overall Survival

    ten years

  • Quality of Life Questionnaire

    ten years

Study Arms (2)

Hypofractionated WBI

ACTIVE COMPARATOR

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

Accelerated Partial Breast Irradiation

EXPERIMENTAL

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

Interventions

Hypofractionated WBIRADIATION

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.

Hypofractionated WBI
Accelerated Partial Breast IrradiationRADIATION

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.

Accelerated Partial Breast Irradiation

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marta Scorsetti, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 2, 2015

Study Start

January 19, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

IT(1)