Back to resultsAccelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery (LAPIDARY)
Primary Purpose
Malignant Neoplasm of Breast
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Comparator: Standard
Experimental 1: Hypofractionated radiotherapy
Experimental 2: Accelerated Partial Breast Irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Neoplasm of Breast focused on measuring Breast Cancer, Radiotherapy, Hypofractionated, Breast-conserving surgery
Eligibility Criteria
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
Sites / Locations
- IBCC OncologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Active Comparator: Standard
Experimental 1: Hypofractionated radiotherapy
Experimental 2: Accelerated Partial Breast Irradiation
Arm Description
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
Outcomes
Primary Outcome Measures
Rate of local recurrence
To estimate and compare the rate of local recurrence between the experimental and control arms.
Secondary Outcome Measures
Time to occurrence of distant metastases
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.
Disease-free survival
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.
Overall survival
Overall survival time, defined as number of days from randomization until death or end of follow-up.
Medico-economic study
To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
Health-related Quality of Life
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.
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)
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.
Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
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.
Measurement Satisfaction of Body Image of the participants
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.
Changes in anxiety and depression
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.
Early and late adverse effects in normal tissues
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Late adverse effects
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.
Acute toxicity rate
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.
Full Information
NCT ID
NCT04669873
First Posted
December 4, 2020
Last Updated
March 4, 2021
Sponsor
Instituto Brasileiro de Controle do Cancer
1. Study Identification
Unique Protocol Identification Number
NCT04669873
Brief Title
Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Acronym
LAPIDARY
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
December 7, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Brasileiro de Controle do Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Breast
Keywords
Breast Cancer, Radiotherapy, Hypofractionated, Breast-conserving surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Standard
Arm Type
Active Comparator
Arm Description
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
Arm Title
Experimental 1: Hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
Arm Title
Experimental 2: Accelerated Partial Breast Irradiation
Arm Type
Experimental
Arm Description
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
Intervention Type
Radiation
Intervention Name(s)
Active Comparator: Standard
Intervention Description
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
Intervention Type
Radiation
Intervention Name(s)
Experimental 1: Hypofractionated radiotherapy
Intervention Description
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
Intervention Type
Radiation
Intervention Name(s)
Experimental 2: Accelerated Partial Breast Irradiation
Intervention Description
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
Primary Outcome Measure Information:
Title
Rate of local recurrence
Description
To estimate and compare the rate of local recurrence between the experimental and control arms.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Time to occurrence of distant metastases
Description
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.
Time Frame
5 years
Title
Disease-free survival
Description
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.
Time Frame
5 years
Title
Overall survival
Description
Overall survival time, defined as number of days from randomization until death or end of follow-up.
Time Frame
5 years
Title
Medico-economic study
Description
To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
Health-related Quality of Life
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
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)
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
Measurement Satisfaction of Body Image of the participants
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
Changes in anxiety and depression
Description
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.
Time Frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Title
Early and late adverse effects in normal tissues
Description
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Time Frame
5 years
Title
Late adverse effects
Description
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.
Time Frame
5 years
Title
Acute toxicity rate
Description
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.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Barbieri
Phone
+551198639-1945
Email
edurxt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alayne D Yamada, PhD
Phone
+55113474-4242
Email
alayne.pesquisa@ibcc-mooca.org.br
Facility Information:
Facility Name
IBCC Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03102-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Barbieri
Phone
+55 11 98639-1945
Email
edurxt@gmail.com
First Name & Middle Initial & Last Name & Degree
Alayne D Yamada, PhD
Phone
+55113474-4242
Email
alayne.pesquisa@ibcc-mooca.org.br
First Name & Middle Initial & Last Name & Degree
Eduardo Barbieri
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The findings will be shared and discussed with all investigators in the study. A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.
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Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
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