BridgeMD
New treatment option for Breast Cancer
Official title Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
ClinicalTrials.gov ID: NCT05491395
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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;
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barretos, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barretos, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.