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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Radiation Oncology Department
RECRUITING
Barretos
Contact Information
Primary
Marcos D Mattos, MD, MS
marcosbtos3@gmail.com
+5517981140230
Backup
Alexandre A Jacinto, MD, PhD
jacintoaa@gmail.com
+5517974001314
Time Frame
Start Date: 2022-06-27
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 120
Treatments
Experimental: Post Mastectomy Hypofractionated Radiotherapy Arm
Post Mastectomy Hypofractionated Radiotherapy Arm
No_intervention: Post Mastectomy Conventional Radiotherapy
Post Mastectomy Conventional Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Barretos Cancer Hospital

This content was sourced from clinicaltrials.gov