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

Sponsor
Instituto Brasileiro de Controle do Cancer (Other)
Overall Status
Recruiting
CT.gov ID
NCT04669873
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
69.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Active Comparator: Standard
  • Radiation: Experimental 1: Hypofractionated radiotherapy
  • Radiation: Experimental 2: Accelerated Partial Breast Irradiation
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Mar 4, 2021
Anticipated Primary Completion Date :
Dec 7, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Comparator: Standard

Whole breast Radiotherapy, 40 Gray (40Gy) fractions

Radiation: Active Comparator: Standard
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
Experimental: Experimental 1: Hypofractionated radiotherapy

Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions

Radiation: Experimental 1: Hypofractionated radiotherapy
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
Experimental: Experimental 2: Accelerated Partial Breast Irradiation

Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.

Radiation: Experimental 2: Accelerated Partial Breast Irradiation
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Outcome Measures

Primary Outcome Measures

  1. Rate of local recurrence [5 years]

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

Secondary Outcome Measures

  1. Time to occurrence of distant metastases [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 [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 [5 years]

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

  4. Medico-economic study [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 [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) [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) [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 [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 [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 [5 years]

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

  11. Late adverse effects [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IBCC Oncologia Sao Paulo SP Brazil 03102-002

Sponsors and Collaborators

  • Instituto Brasileiro de Controle do Cancer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eduardo Barbieri, Principal Investigator, Instituto Brasileiro de Controle do Cancer
ClinicalTrials.gov Identifier:
NCT04669873
Other Study ID Numbers:
  • 38341220.8.0000.0072
First Posted:
Dec 17, 2020
Last Update Posted:
Mar 8, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eduardo Barbieri, Principal Investigator, Instituto Brasileiro de Controle do Cancer
Breast Cancer
Radiotherapy
Hypofractionated
Breast-conserving surgery
Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms

Study Results

No Results Posted as of Mar 8, 2021