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NCT Number: NCT04669873

Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.

There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.

Recruiting

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Key information

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Information to the patient and signed informed consent;
  • Women aged ≥50 years
  • Breast conserving surgery
  • Pathologic tumor size < 3 cm (maximum microscopic diameter of the invasive component)
  • Invasive adenocarcinoma (except classic invasive lobular carcinoma)
  • Unifocal disease
  • Histopathologic grades I or II
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Lymphovascular invasion absent
  • Negative axillary lymph nodes
  • Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
  • No prior breast or mediastinal radiotherapy
  • No hematogenous metastases

Exclusion criteria

  • Previous malignancy (except non-melanomatous skin cancer)
  • Mastectomy
  • Classical-Type Invasive Lobular Carcinoma
  • Neoadjuvant chemotherapy
  • Human Epidermal growth factor Receptor-type 2 positive (HER2+)
  • Triple-negative breast cancers
  • Intravascular lymphoma present
  • Contraindications to radiotherapy.
  • No geographical, social or psychologic reasons that would prevent study follow

Treatment and study plan

Active Comparator: Standard

Radiation

Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks

Experimental 1: Hypofractionated radiotherapy

Radiation

Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week

Experimental 2: Accelerated Partial Breast Irradiation

Radiation

Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Primary outcomes

  1. Rate of local recurrence

    Time frame: 5 years

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

Secondary outcomes

  1. Time to occurrence of distant metastases

    Time frame: 5 years

    Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.

  2. Disease-free survival

    Time frame: 5 years

    Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

  3. Overall survival

    Time frame: 5 years

    Overall survival time, defined as number of days from randomization until death or end of follow-up.

  4. Medico-economic study

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation

  5. Health-related Quality of Life

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.

  6. Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

  7. Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). Scores are interpreted according to the guidelines of the Scoring Manual. The higher the number of points, the better the quality of life. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.

  8. Measurement Satisfaction of Body Image of the participants

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.

  9. Changes in anxiety and depression

    Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

    To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS). Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.

  10. Early and late adverse effects in normal tissues

    Time frame: 5 years

    To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.

  11. Late adverse effects

    Time frame: 5 years

    To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.

  12. Acute toxicity rate

    Time frame: 5 years

    To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.

Study contacts

Contact information is provided by the study sponsor or research team.

Alayne D Yamada, PhD

CONTACT

[email protected]

+55113474-4242

Eduardo Barbieri

CONTACT

[email protected]

+551198639-1945

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Controle do Cancer

Other

Registry information

Official study title

Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery

Acronym: LAPIDARY

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2020
Registry last updated
Mar 8, 2021

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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