Hypofractionated radiotherapy for breast cancer patients with prosthetic reconstruction
Randomized Phase III Clinical Trial of Hypofractionated Radiotherapy in Breast Cancer Patients With Immediate Prosthetic Reconstruction: PROMART Trial
NA · Barretos Cancer Hospital · NCT05491395
This study is testing a shorter course of radiation therapy for women with breast cancer who have had breast implants to see if it causes fewer complications and helps them feel better compared to standard radiation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Barretos Cancer Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barretos, São Paulo) |
| Trial ID | NCT05491395 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with invasive ductal or lobular breast carcinoma who have undergone radical mastectomy with immediate prosthetic reconstruction and are indicated for adjuvant radiotherapy.
Not a fit: Patients with other types of breast cancer histology, previous cancer treatments, or distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer radiotherapy option that minimizes complications for breast cancer patients with prosthetic reconstruction.
How similar studies have performed: While there is limited consensus on hypofractionated radiotherapy for this specific patient population, similar studies have shown promising results in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Barretos, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast cancer, radiation therapy, hypofractionated, biomarkers