Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

NCT05850637 | Completed Phase 2

• 1 other identifier: INSTITUTO PREVENT SENIOR - IPS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Conditions

Breast Cancer Female

Keywords

Breast Cancer; Adjuvant radiotherapy; Ultra-hypofractionated

Outcome Measures

Primary Outcomes (2)

• Acute toxicity

  Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0

  Events of radiotherapy up to 3 months

• Late toxicity

  Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.

  Events after 3 months of radiotherapy completion

Secondary Outcomes (5)

• Locoregional free survival

  3 years

• Distant free survival

  3 years

• Overall survival

  3 years

• Cosmesis change

  week 10 and week 26 after the end of the treatment

• QOL (Quality of Life) changes

  3 years

Other Outcomes (1)

• Breast volume and toxicity relationship

  3 years

Study Arms (1)

Single Arm Ultra-hypofractionated

EXPERIMENTAL

5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains

Radiation: adjuvant ultra-hypofractionated radiotherapy

Interventions

adjuvant ultra-hypofractionated radiotherapy RADIATION

adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer

Single Arm Ultra-hypofractionated

Eligibility Criteria

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

You may qualify if:

• Female patient;
• Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
• Age greater than or equal to 65 years;
• Breast-conserving surgery or mastectomy with or without axillary approach
• With or without neoadjuvant or adjuvant systemic treatment

You may not qualify if:

• Patients with previous thoracic irradiation;
• Patients with indication for bilateral thoracic irradiation;
• Patients with breast reconstruction with prosthesis or autologous tissue;
• Patients with compromised surgical margins after resection;
• pT1-pT2 pN0 patients undergoing radical mastectomy.

Sponsors & Collaborators

• Prevent Senior Institute: lead

Study Sites (1)

Instituto de Pesquisa Prevent Senior

São Paulo, Brazil

Location

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  PMID: 40053900 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcel MF Fang, MD

  Instituto de Pesquisa Prevent Senior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective phase 2 non-randomized single-arm study

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 9, 2023
• Study Start: January 30, 2019
• Primary Completion: February 11, 2021
• Study Completion: April 1, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BR (1)