Skip to main content
OpenTrials
Completed

NCT Number: NCT05850637

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Pesquisa Prevent Senior

São Paulo, Brazil

About this study

Prospective phase 2 non-randomized single-arm 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

adjuvant ultra-hypofractionated radiotherapy

Radiation

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

Primary outcomes

  1. Acute toxicity

    Time frame: Events of radiotherapy up to 3 months

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

  2. Late toxicity

    Time frame: Events after 3 months of radiotherapy completion

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

Secondary outcomes

  1. Locoregional free survival

    Time frame: 3 years

    from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence

  2. Distant free survival

    Time frame: 3 years

    from the date of initiation of treatment until the date of progression of distant disease evidence

  3. Overall survival

    Time frame: 3 years

    defined from the date of initiation of treatment until the patient's death

  4. Cosmesis change

    Time frame: week 10 and week 26 after the end of the treatment

    was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up.

    • Excellent: When compared to the untreated breast, there is no difference or minimal difference in the size or shape of the treated breast. The breast texture is the same or slightly different. There may be thickening, scar tissue, or fluid buildup in the breast, but not enough to change the appearance.
    • Good: There is a slight difference in the size or shape of the treated breast compared to the untreated breast or compared to the original appearance of the treated breast. There may be a slight reddening or darkening of the breast. Thickening or scar tissue inside the breast causes only a slight change in shape or size.
    • Fair: Obvious difference in the size and shape of the treated breast. This change involves a quarter or less of the breast. There may be

  5. QOL (Quality of Life) changes

    Time frame: 3 years

    was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Other outcomes

  1. Breast volume and toxicity relationship

    Time frame: 3 years

    We analyzed the impact of CTV (Clinical Target Volume) volume (representing breast size), and dosimetric data, with a special focus on the maximum dose and dose in homogeneity (defined as the absolute volumes of breast tissue exposed to ≥100%, ≥104% and ≥107% of the prescribed dose

Sponsors and collaborators

Lead sponsor

Prevent Senior Institute

Other

Registry information

Official study title

Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
May 9, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.