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NCT Number: NCT05318274

Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ductal Breast Carcinoma In Situ Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Early-Stage Breast Cancer Invasive Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage 0 Breast Cancer Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidad Medica de Alta Especialidad

Mérida, Yucatán, 97150, Mexico

About this study

PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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).

X. 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

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

Other names: 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

Primary outcomes

  1. Identify the progression timing.

    Time frame: 5 years

    Quantify the time to progression through follow up in both groups

  2. Identify the recurrence timing.

    Time frame: 5 years

    Quantify the time to recurrence through follow up in both groups

Secondary outcomes

  1. Identify the histological lineage of the tumor

    Time frame: 14 Months

    Carcinoma InSitu or Invasive Carcinoma;

    • - Adenocarcinoma
    • - Other

  2. Identify the degree of differentiation of tumor cells

    Time frame: 14 months

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

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

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

    Time frame: 14 months

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

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

  4. Measure the frequency of toxicity in both groups.

    Time frame: 5 years

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

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

  5. Classify toxicity according to its severity.

    Time frame: 5 years

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

    • 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
    • Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters.
    • Grade 1 to 3
    • Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition.
    • Grade 1 to 2
    • Dysphagia: A disorder characterized by difficulty in swallowing.
    • Grade 1 to 4
    • 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
    • Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
    • Grade 1 to 5

Other outcomes

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

    Time frame: 5 Years

    Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group

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

    Time frame: 5 Years

    Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2022
Registry last updated
Mar 23, 2026

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.

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