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NCT Number: NCT05491395

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

RATIONALE:

Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome.

There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis.

PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

General aim: To evaluated if hypofractionated accelerated radiotherapy in patients with breast cancer undergoing immediate breast implant reconstruction surgery is non inferior to conventional radiotherapy.

Aim 1 (Primary objective): Assess the G3 toxicity rate - loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning).

Aim 2 (Specific secondary objectives):

  • Compare local recurrence rate between two groups;
  • Compare quality of life index between two groups using EORTC QLQ-C30 / EORTC QLQ-BR45 scales during treatment, after 6 and 12 months after treatment ending;
  • Compare self-image differences between groups;
  • Compare acute and late radiodermatitis rates by CTCAE 4.0;
  • Analyse dosimetric planning differences considering the volumes of all breast and breast without prosthesis;
  • Study inflammation molecular markers, which may indicate an increased risk of fibrosis;
  • Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional;
  • Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with confirmed histological diagnosis of invasive ductal carcinoma and lobular breast carcinoma;
  • Radical mastectomy with immediate reconstruction with a prosthesis;
  • Patients indicated for adjuvant RT;
  • Any lymph node status;
  • With or without adjuvant chemotherapy;
  • ECOG performance status from 0-2;
  • > 18 years old;
  • Informed Consent Form applied before any study-specific procedure.

Exclusion criteria

  • Another histological diagnosis than invasive ductal carcinoma or lobular carcinoma;
  • Previous history of neoplasm and/or radiotherapy and/ or quimiotherapy before this study;
  • Distant metastatic disease;
  • Palliative treatment;
  • Patients with scleroderma / systemic lupus erythematosus.

Treatment and study plan

hypofractionation

Radiation

Hypofractionation scheme will comprise 40 Gy in 15 fractions

Primary outcomes

  1. Assess the G3 toxicity rate

    Time frame: 2 years

    loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)

Secondary outcomes

  1. Local recurrence

    Time frame: 5 years

    Compare local recurrence rate between two groups

  2. Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

    Time frame: 2 years

    Compare quality of life index between two groups using EORTC scales during treatment, after 6 and 12 months after treatment ending

  3. Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

    Time frame: 5 years

    Compare self-image differences between groups

  4. Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0

    Time frame: 2 years

    Acute and late radiodermatitis rateswill be evaluated by CTCAE 4.0 scale, using the adverse event (AE) reporting. A grading (severity) scale is provided for each AE term.

  5. Dosimetric analysis

    Time frame: 5 years

    Analyze dosimetric planning differences considering the volumes of all breast and breast without prosthesis

  6. Inflammation markers screening - detection of cytokines with the CBA panel

    Time frame: 3 years

    Study inflammation molecular markers, which may indicate an increased risk of fibrosis. The cytokines present in the plasma will be evaluated using the Cytometric Beads Array technique with the CBA panel - Human Th1/Th2/Th17CBAKit which, through beads, is able to identify the expression of cytokines expressed by Th1, Th2 standard lymphocytes and Th17, including IL-2, IL-4, IL-6, IL-10, IL-17A, TNF e IFN-γ. After proper labeling, the immunophenotypic analyzes will be performed in a BD FAC Symphony flow cytometer.

  7. Extracellular vesicles isolation and characterization

    Time frame: 4 years

    Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional

  8. Evaluate extracellular vesicles molecular profile

    Time frame: 4 years

    Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre A Jacinto, MD, PhD

CONTACT

[email protected]

+5517974001314

Marcos D Mattos, MD, MS

CONTACT

[email protected]

+5517981140230

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

Randomized Phase III Clinical Trial of Hypofractionated Radiotherapy in Breast Cancer Patients With Immediate Prosthetic Reconstruction: PROMART Trial

Acronym: PROMART

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Aug 8, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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