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

NCT03101683 | Unknown

• 1 other identifier: PCWRT-01
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assess feasibility , defined as patient set-up reproducibility, plan reproducibility through in vivo dosimetry and dosimetrical reduction of PCWRT vs. conventional chest wall radiotherapy

  Evaluation of reproducibility of the technique. Evaluation of dose administered to non-target organ.

  5 weeks

Secondary Outcomes (4)

• Assess safety basing on RTOG ACUTE Radiation Morbidity and RTOG/EORTC LATE Radiation Morbidity

  6-24 months following the completion of radiation therapy

• Assess surgical complication using a four-step scale of capsular contracture after prosthetic breast reconstruction

  6, 12, 18 and 24 months following the completion of radiation therapy

• Assess cosmetic outcome using a qualitative scale (excellent-good-fair-poor)

  1, 3, 6, 12, 18 and 24 months following the completion of radiation therapy

• Assess patients' satisfaction throuhg a questionnaire administered to patients

  12 months following the completion of radiation therapy

Study Arms (1)

PCWRT Group

EXPERIMENTAL

Patients with diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction who have some additional risk factors will receive a partial chest wall radiotherapy

Radiation: Partial chest wall radiation therapy

Interventions

Partial chest wall radiation therapy RADIATION

A dose of 40 Gy in 16 fractions (2.5 Gy per fraction) is delivered in the area at risk of local recurrence (skin and the pectoralis muscles) delineated by surgical clips and 3D-MRI reconstruction for a precise localization of the tumor excised

PCWRT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Grade 3 histology
• 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 margins in a single breast quadrant
• Age ≤50 years
• Tumor diameter \>2 cm
• Grade 3 histology
• Lymphovascular invasion
• HER-2 overexpression/amplification

You may not qualify if:

• Stages IIIB, IIIC and IV (any T4, any N3 or M1)
• Pathological metastasis in ≥2 axillary lymph nodes, clinically apparent metastasis in internal mammary and/or supraclavicular lymph nodes
• Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in multiple breast quadrants
• Patients submitted to neoadjuvant chemotherapy
• Recurrence of breast cancer following mastectomy and/or adjuvant chemotherapy.
• Concomitant primary cancer in the contralateral breast
• History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
• Pregnant or breast-feeding
• Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia)
• Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
• Severe psychiatric disorder that may interfere with the process of informed consent and/or treatment or follow-up compliance

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Riccardo Ponzone, MD

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Ponzone, MD

CONTACT

+39 011993; riccardo.ponzone@ircc.it

Nicoletta Tomasi Cont, MD

CONTACT

+39 011993; nicoletta.tomasicont@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 5, 2017
• Study Start: October 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: September 30, 2019
• Last Updated: September 5, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share