NCT03101683

Radiotherapy After Mastectomy for Breast Cancer Patients at Increased Risk of Local Recurrence

Status unknown NA Last updated 5 September 2017

What this trial tests

NA trial testing Partial chest wall radiation therapy in Breast Cancer in 28 participants. Status unknown.

Timeline

1 October 2017

Primary endpoint
30 April 2019

30 September 2019

Quick facts

Lead sponsor	Fondazione del Piemonte per l'Oncologia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 October 2017
Primary completion	30 April 2019
Estimated completion	30 September 2019

Drugs / interventions tested

• Partial chest wall radiation therapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Fondazione del Piemonte per l'Oncologia — full company profile →

Who can join

Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at increased risk of local relapse submitted to nipple-areola complex (NAC) sparing mastectomy and immediate implant-based reconstruction Inclusion criteria

Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction (expander or prosthesis) and:

Group A)

Negative sentinel node dissection or axillary clearance (pN0) and all the following risk factors:

Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant Tumor diameter \>2 cm Age ≤50 years Group B)

Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary clearance) with only 1 positive node and any of the following risk factors:

Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant Age ≤50 years Tumor diameter \>2 cm Grade 3 histology Lymphovascular invasion HER-2 overexpression/amplification Triple negativity Treatment - Radioterapy The tumor bed is defined by the area at risk (skin and the pectoralis muscles) delineated by surgical clips and 3D-MRI reconstruction for a precise localization of the tumor excised. The clinical target volume (CTV) is defined as the tumor bed with a 1.5 cm margin limited by skin contour.

A dose of 40 Gy is delivered in 16 fractions (2.5 Gy per fraction). For conventional post-mastectomy radiotherapy this moderately hypofractionated schedule is considered feasible and safe (31). Even more so, this schedule should be feasible and safe for a smaller irradiated volume as in the current protocol. Regional nodal irradiation is not considered at our Institution for patients fulfilling the entry criteria of the protocol.

OUTCOME MEASURES Primary To assess feasibility of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To assess the safety of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To assess the surgical complication of implant-based breast reconstruction after PCWRT Secondary To assess the cosmetic outcome of implant-based breast reconstruction after PCWRT To assess patients' satisfaction of implant-based breast reconstruction after PCWRT

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of Adjuvant Radiotherapy in the Treatment of Breast Cancer.
   Kolářová I, Melichar B, Sirák I, Vaňásek J, et al · · 2024 · cited 12× · PMID 38534923 · DOI 10.3390/curroncol31030090