Clinical trial · Interventional
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
Randomized Phase III Clinical Trial of Hypofractionated Radiotherapy in Breast Cancer Patients With Immediate Prosthetic Reconstruction: PROMART Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Post Mastectomy Hypofractionated Radiotherapy Arm
- description
- Post Mastectomy Hypofractionated Radiotherapy Arm
- interventionNames
- Radiation: Hypofractionation
- type
- NO_INTERVENTION
- label
- Post Mastectomy Conventional Radiotherapy
- description
- Post Mastectomy Conventional Radiotherapy
Primary outcomes (1)
- measure
- Assess the G3 toxicity rate
- timeFrame
- 2 years
- description
- loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDHalsted WS. I. The Results of Operations for the Cure of Cancer of the Breast Performed at the Johns Hopkins Hospital from June, 1889, to January, 1894. Ann Surg. 1894 Nov;20(5):497-555. doi: 10.1097/00000658-189407000-00075. No abstract available. PMID 17860107
- BACKGROUNDVeronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E, Muscolino G, Rilke F, Salvadori B, Zecchini A, Zucali R. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981 Jul 2;305(1):6-11. doi: 10.1056/NEJM198107023050102. PMID 7015141
- BACKGROUNDSong SY, Chang JS, Fan KL, Kim MJ, Chang HP, Lew DH, Roh TS, Roh H, Kim YB, Lee DW. Hypofractionated Radiotherapy With Volumetric Modulated Arc Therapy Decreases Postoperative Complications in Prosthetic Breast Reconstructions: A Clinicopathologic Study. Front Oncol. 2020 Nov 17;10:577136. doi: 10.3389/fonc.2020.577136. eCollection 2020. PMID 33282731
- BACKGROUNDLiu L, Yang Y, Guo Q, Ren B, Peng Q, Zou L, Zhu Y, Tian Y. Comparing hypofractionated to conventional fractionated radiotherapy in postmastectomy breast cancer: a meta-analysis and systematic review. Radiat Oncol. 2020 Jan 17;15(1):17. doi: 10.1186/s13014-020-1463-1. PMID 31952507
- BACKGROUNDSBRT, Brazilian Society of Radiotherapy; Freitas NMA, Rosa AA, Marta GN, Hanna SA, Hanriot RM, Borges ABB, Gondim GRM, Pellizzon ACA, Veras IM, Almeida Junior WJ, Fernandez CRSHW, Batalha Filho ES, Castilho MS, Kuhnen FQ, Najas RMXF, Affonso Junior RJ, Leite ACC, Ribeiro HLM, Freitas Junior R, Oliveira HF. Recommendations for hypofractionated whole-breast irradiation. Rev Assoc Med Bras (1992). 2018 Sep;64(9):770-777. doi: 10.1590/1806-9282.64.09.770. PMID 30672995
- BACKGROUNDVan Poznak C, Somerfield MR, Bast RC, Cristofanilli M, Goetz MP, Gonzalez-Angulo AM, Hicks DG, Hill EG, Liu MC, Lucas W, Mayer IA, Mennel RG, Symmans WF, Hayes DF, Harris LN. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2015 Aug 20;33(24):2695-704. doi: 10.1200/JCO.2015.61.1459. Epub 2015 Jul 20.