NCT05452083

Brief Summary

Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
112mo left

Started Aug 2022

Longer than P75 for all trials

Status
not yet 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 Progress29%
Aug 2022Jul 2035

First Submitted

Initial submission to the registry

April 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2035

Expected
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

April 22, 2022

Last Update Submit

July 6, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

    Evaluation during treatment and at each follow-up visit up to 10 years

    08/2022 - 07/2035

Secondary Outcomes (6)

  • Cosmetic results according to the Harvard-scale

    05/2022 - 04/2035

  • In-breast recurrence rate

    05/2022 - 04/2035

  • Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23

    05/2022 - 04/2035

  • Immune status analysis: Immunophenotyping using peripheral blood at several time points

    05/2022 - 04/2027

  • Overall survival

    05/2022 - 04/2035

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.

You may qualify if:

  • Histologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS)
  • pT-category pT0-3
  • complete resection (R0)
  • Absence of distant metastasis (M0)
  • Absence of contralateral breast cancer/ DCIS
  • Karnofsky Performance Score ≥ 60%
  • Age ≥ 18 years at time of study entry
  • Written informed consent

You may not qualify if:

  • Morbus Paget or pathological skin infiltration
  • Earlier or synchronous breast cancer
  • Pregnant or breast-feeding women
  • Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
  • Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood withdrawals for dynamic immune status

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Claudia Schweizer

Study Record Dates

First Submitted

April 22, 2022

First Posted

July 11, 2022

Study Start

August 1, 2022

Primary Completion

July 30, 2025

Study Completion (Estimated)

July 30, 2035

Last Updated

July 11, 2022

Record last verified: 2022-07