NCT05665920

Brief Summary

The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2022Dec 2030

Study Start

First participant enrolled

October 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2027

Expected
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

December 16, 2022

Last Update Submit

December 26, 2022

Conditions

Malignant Breast Neoplasm

Keywords

Dose splittingAcute and late toxicityLocoregional drainage irradiationBreast neoplasmOverall survivalDisease-free survivalLocoregional control

Outcome Measures

Primary Outcomes (1)

  • Locoregional recurrence (LRR)

    To estimate and compare the rate of local recurrence between the experimental and control arms.

    10 years

Secondary Outcomes (8)

  • Overall survival

    10 years

  • Disease-free survival

    10 years

  • Locoregional control

    10 years

  • Early and late adverse effects in normal tissues

    10 years

  • Late adverse effects

    10 years

  • +3 more secondary outcomes

Study Arms (2)

Standard Whole breast Radiotherapy

ACTIVE COMPARATOR

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Radiation: Standard Radiation

Ultra-hypofractionated whole breast radiotherapy

EXPERIMENTAL

Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Radiation: Ultra-hypofractionated whole breast radiotherapy

Interventions

Ultra-hypofractionated whole breast radiotherapyRADIATION

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Ultra-hypofractionated whole breast radiotherapy
Standard RadiationRADIATION

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Standard Whole breast Radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Information to the patient and signed informed consent;
  • Women aged ≥18 years;
  • Breast conserving surgery;
  • Invasive adenocarcinoma (except classic invasive lobular carcinoma);
  • TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
  • Eastern Cooperative Oncology Group (ECOG) 0 -1;
  • Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
  • No previous breast or mediastinal radiotherapy;
  • No hematogenous metastases;
  • Ability to carry out long-term follow-up;

You may not qualify if:

  • Previous local irradiation;
  • Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
  • Histology of metaplastic carcinoma;
  • History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
  • Diagnosis of autoimmune and connective tissue diseases;
  • Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
  • Indication of internal breast irradiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBCC Oncologia

São Paulo, São Paulo, 03102-002, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eduardo Barbieri

    IBCC Oncologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Barbieri

CONTACT

+551198639-1945edurxt@gmail.com

Alayne Yamada, PhD

CONTACT

+55114450-0347alayne.yamada@hospitalsaocamilosp.org.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

October 18, 2022

Primary Completion (Estimated)

October 18, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)