Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

NCT05491395 | Recruiting

• 1 other identifier: 1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer, radiation therapy, hypofractionated, biomarkers

Outcome Measures

Primary Outcomes (1)

• Assess the G3 toxicity rate

  loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)

  2 years

Secondary Outcomes (8)

• Local recurrence

  5 years

• Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

  2 years

• Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire

  5 years

• Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  2 years

• Dosimetric analysis

  5 years

Study Arms (2)

Post Mastectomy Hypofractionated Radiotherapy Arm

EXPERIMENTAL

Post Mastectomy Hypofractionated Radiotherapy Arm

Radiation: Hypofractionation

Post Mastectomy Conventional Radiotherapy

NO INTERVENTION

Post Mastectomy Conventional Radiotherapy

Interventions

Hypofractionation RADIATION

Hypofractionation scheme will comprise 40 Gy in 15 fractions

Post Mastectomy Hypofractionated Radiotherapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• ECOG performance status from 0-2;
• \> 18 years old;
• Informed Consent Form applied before any study-specific procedure.

You may not qualify 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Radiation Oncology Department

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Related Publications (11)

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  PMID: 17860107 BACKGROUND

• Veronesi 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 BACKGROUND

• Song 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 BACKGROUND

• Liu 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 BACKGROUND

• SBRT, 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 BACKGROUND

• Van 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.

  PMID: 26195705 BACKGROUND

• Nimeus-Malmstrom E, Krogh M, Malmstrom P, Strand C, Fredriksson I, Karlsson P, Nordenskjold B, Stal O, Ostberg G, Peterson C, Ferno M. Gene expression profiling in primary breast cancer distinguishes patients developing local recurrence after breast-conservation surgery, with or without postoperative radiotherapy. Breast Cancer Res. 2008;10(2):R34. doi: 10.1186/bcr1997. Epub 2008 Apr 22.

  PMID: 18430221 BACKGROUND

• Tramm T, Kyndi M, Myhre S, Nord S, Alsner J, Sorensen FB, Sorlie T, Overgaard J. Relationship between the prognostic and predictive value of the intrinsic subtypes and a validated gene profile predictive of loco-regional control and benefit from post-mastectomy radiotherapy in patients with high-risk breast cancer. Acta Oncol. 2014 Oct;53(10):1337-46. doi: 10.3109/0284186X.2014.925580. Epub 2014 Jun 24.

  PMID: 24957550 BACKGROUND

• Kowal J, Arras G, Colombo M, Jouve M, Morath JP, Primdal-Bengtson B, Dingli F, Loew D, Tkach M, Thery C. Proteomic comparison defines novel markers to characterize heterogeneous populations of extracellular vesicle subtypes. Proc Natl Acad Sci U S A. 2016 Feb 23;113(8):E968-77. doi: 10.1073/pnas.1521230113. Epub 2016 Feb 8.

  PMID: 26858453 BACKGROUND

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  PMID: 33472857 BACKGROUND

• Back M, Guerrieri M, Wratten C, Steigler A. Impact of radiation therapy on acute toxicity in breast conservation therapy for early breast cancer. Clin Oncol (R Coll Radiol). 2004 Feb;16(1):12-6. doi: 10.1016/j.clon.2003.08.005.

  PMID: 14768750 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Marcos D Mattos, MD, MS

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Gabriela B Salvador, BS

  Barretos Cancer Hospital

  STUDY CHAIR

• Wanessa F Altei, PhD

  Barretos Cancer Hospital

  STUDY CHAIR

• Lais L Almeida, MD

  Barretos Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Marcos D Mattos, MD, MS

CONTACT

+5517981140230; marcosbtos3@gmail.com

Alexandre A Jacinto, MD, PhD

CONTACT

+5517974001314; jacintoaa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm Experimental: Post Mastectomy Hypofractionated Radiotherapy Arm No Intervention: Post Mastectomy Conventional Radiotherapy

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: August 8, 2022
• Study Start: June 27, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 8, 2022

Record last verified: 2022-06

Locations

BR (1)