Hypofractionated radiotherapy for breast cancer patients with prosthetic reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of hypofractionated radiotherapy in women with breast cancer who have undergone immediate prosthetic reconstruction. It aims to determine the rate of severe complications, such as capsular contracture and prosthesis loss, and compares these outcomes to those of patients receiving conventional radiotherapy. Additionally, the study will assess local recurrence rates, quality of life, and molecular markers related to inflammation and fibrosis. The research will involve analyzing patient-derived blood samples to understand the biological factors contributing to complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radiation Oncology Department
  Barretos, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Marcos D Mattos, MD, MS — Barretos Cancer Hospital
• Study coordinator: Marcos D Mattos, MD, MS
• Email: marcosbtos3@gmail.com
• Phone: +5517981140230

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.