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Ductal Breast Carcinoma in SituNCT05318274

Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

A study testing Hypofractionated radiotherapy in people with Ductal Breast Carcinoma in Situ and Invasive Breast Cancer, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Hypofractionated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteMexico
Study dates
26 Apr 2021to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Unidad Medica de Alta Especialidad

    Mérida, Yucatán, 97150

Other trials in Mexico

About this study

Official title: Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery.

SECONDARY OBJECTIVES:

  1. Identify the histological lineage of the tumor.

II. Identify the degree of differentiation of tumor cells.

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

IV. Measure the frequency of progression or recurrence.

  1. Identify the site of progression or recurrence.

VI. Measure the frequency of toxicity in both groups.

VII. Classify toxicity according to its severity.

VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic.

IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).

  1. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale.

XI. Measure 5-year survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.

ARM II: will receive 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.

After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years

Being tested
Hypofractionated radiotherapy
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated radiotherapyRadiation

    Also called Adjuvant Radiation Therapy, External Beam Radiotherapy, 3D Conformal Radiation Therapy, Intensity Modulated Radiation Therapy

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

Study groups in NCT05318274
Study groupRoleWhat they receive
ARM IExperimentalRadiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.
Receives: Radiation: Hypofractionated radiotherapy
ARM IIActive comparatorRadiotherapy 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.
Receives: Radiation: Hypofractionated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify the progression timing.

    Quantify the time to progression through follow up in both groups

    Measured: 5 years

  2. Identify the recurrence timing.

    Quantify the time to recurrence through follow up in both groups

    Measured: 5 years

Secondary outcomes (5)

  1. Identify the histological lineage of the tumor

    Carcinoma InSitu or Invasive Carcinoma;

    1. - Adenocarcinoma
    2. - Other

    Measured: 14 Months

  2. Identify the degree of differentiation of tumor cells

    Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale

    1. Grade 1: 3-5 points
    2. Grade 2: 6-7 points
    3. Grade 3: 8-9 points

    Measured: 14 months

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

    Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype.

    1. Luminal A: RE (+), RP >20%, Ki67 <20% y HER 2 NEU (-)
    2. Luminal B: RE (+), RP <20%, Ki67 >20% y HER 2 NEU (+/-)
    3. HER-2 Enriched: RE (-), RP (-),Ki67 any, HER 2 NEU (+)
    4. Triple Negative: RE (-), RP (-), Ki67 any, HER-2 (-)

    Measured: 14 months

  4. Measure the frequency of toxicity in both groups.

    Quantify the presence of toxicity categorized by CTCAE version 5 system.

    1. Grade 1: characterized by the presence of a mild adverse event that does not require treatment
    2. Grade 2: considers a moderate adverse event that may require medical treatment on an outpatient basis
    3. Grade 3: is a serious adverse event that should receive medical treatment, and even hospital treatment.
    4. Grade 4: is an adverse event with risk of death or disability that requires specialized medical management and hospitalization.
    5. Grade 5: considers the presence of death associated with an adverse event.

    Measured: 5 years

  5. Classify toxicity according to its severity.

    Quantify toxicity according to its severity categorized by CTCAE version 5 system.

    1. Dry skin: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture
    • Grade 1 to 3
    1. Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters.
    • Grade 1 to 3
    1. Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition.
    • Grade 1 to 2
    1. Dysphagia: A disorder characterized by difficulty in swallowing.
    • Grade 1 to 4
    1. Cough: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.
    • Grade 1 to 3
    1. Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
    • Grade 1 to 5

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start26 Apr 2021
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318274
Sponsor's protocol ID
R-2021-3203-005
Status last verified
Mar 2026
First submitted
23 Feb 2022
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated radiotherapy in people with Ductal Breast Carcinoma in Situ and Invasive Breast Cancer, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify the progression timing. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05318274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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