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

Cancer of Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02375048
• Other study ID #: 1288
• Status: Terminated
• Phase: Phase 2
• Start date: January 19, 2015
• Est. completion date: February 1, 2018

Study information

• Verified date: October 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer of Breast

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity will be measured with CTCAE v.4.0		ten years
Primary	Cosmesis will be measured with Harvard scale		ten years
Secondary	Rate of Local Control		ten years
Secondary	Disease Free Survival		ten years
Secondary	Overall Survival		ten years
Secondary	Quality of Life Questionnaire		ten years