NCT05318274

Brief Summary

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress89%
Apr 2021Dec 2026

Study Start

First participant enrolled

April 26, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

February 23, 2022

Last Update Submit

March 19, 2026

Conditions

Ductal Breast Carcinoma in SituInvasive Breast CancerEarly-stage Breast CancerStage 0 Breast CancerStage I Breast CancerStage IA Breast CancerStage IB Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Identify the progression timing.

    Quantify the time to progression through follow up in both groups

    5 years

  • Identify the recurrence timing.

    Quantify the time to recurrence through follow up in both groups

    5 years

Secondary Outcomes (5)

  • Identify the histological lineage of the tumor

    14 Months

  • Identify the degree of differentiation of tumor cells

    14 months

  • Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry

    14 months

  • Measure the frequency of toxicity in both groups.

    5 years

  • Classify toxicity according to its severity.

    5 years

Other Outcomes (2)

  • Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).

    5 Years

  • Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG)

    5 Years

Study Arms (2)

ARM I

EXPERIMENTAL

Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.

Radiation: Hypofractionated radiotherapy

ARM II

ACTIVE COMPARATOR

Radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.

Radiation: Hypofractionated radiotherapy

Interventions

Hypofractionated radiotherapyRADIATION

Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

Also known as: Adjuvant Radiation Therapy, External Beam Radiotherapy, 3D Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, IMRT Fixed Gantry Radiation Therapy, Hypofractionated Whole Breast Irradiation, Quality of Life Questionnaire: EORTC QLQ-BR23
ARM IARM II

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale with ductal carcinoma in situ or early breast cancer.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.
  • Treated with breast-conserving surgery and stage pT1-2 pN0 M0.
  • Over 18 years.
  • Patients who sign informed consent for research study.

You may not qualify if:

  • Positive nodes.
  • Clinical or pathological stage T3-T4.
  • History of previous irradiation.
  • Postoperative positive margin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Medica de Alta Especialidad

Mérida, Yucatán, 97150, Mexico

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingBreast NeoplasmsBreast Carcinoma In Situ

Interventions

Radiation Dose HypofractionationRadiotherapy, ConformalRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeuticsRadiotherapy, Computer-Assisted

Study Officials

  • Fernando H Castillo-Lopez, Phy.

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 8, 2022

Study Start

April 26, 2021

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)