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Malignant Neoplasm of BreastLAPIDARYNCT04669873

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

A study testing Active Comparator: Standard, Experimental 1: Hypofractionated radiotherapy and Experimental 2: Accelerated Partial Breast Irradiation in people with Malignant Neoplasm of Breast, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years, women only
Conditions the study is for
Malignant Neoplasm of Breast
What is being tested?
Active Comparator: Standard, Experimental 1: Hypofractionated radiotherapy and Experimental 2: Accelerated Partial Breast Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBrazil
Study dates
4 Mar 2021to 31 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 50 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Intravascular lymphoma present
  • Contraindications to radiotherapy.
  • No geographical, social or psychologic reasons that would prevent study follow

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eduardo Barbieri contact

+551198639-1945

edurxt@gmail.com

Alayne D Yamada, PhD contact

+55113474-4242

alayne.pesquisa@ibcc-mooca.org.br

Brazil1 site, 1 recruiting

  • IBCC Oncologia

    São Paulo, São Paulo, 03102-002

    Eduardo Barbieri, +55 11 98639-1945, edurxt@gmail.com

    Alayne D Yamada, PhD, +55113474-4242, alayne.pesquisa@ibcc-mooca.org.br

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Active Comparator: Standard, Experimental 1: Hypofractionated radiotherapy, Experimental 2: Accelerated Partial Breast Irradiation
Keywords
Breast Cancer, Radiotherapy, Hypofractionated, Breast-conserving surgery
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Active Comparator: StandardRadiation

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

  • Experimental 1: Hypofractionated radiotherapyRadiation

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

  • Experimental 2: Accelerated Partial Breast IrradiationRadiation

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

Study groups in NCT04669873
Study groupRoleWhat they receive
Active Comparator: StandardActive comparatorWhole breast Radiotherapy, 40 Gray (40Gy) fractions
Receives: Radiation: Active Comparator: Standard
Experimental 1: Hypofractionated radiotherapyExperimentalWhole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
Receives: Radiation: Experimental 1: Hypofractionated radiotherapy
Experimental 2: Accelerated Partial Breast IrradiationExperimentalPartial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
Receives: Radiation: Experimental 2: Accelerated Partial Breast Irradiation

What is being measured

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

  1. Rate of local recurrence

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

    Measured: 5 years

Secondary outcomes (12)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. Overall survival

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

    Measured: 5 years

  4. Medico-economic study

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

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

  5. 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.

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

  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)

    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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. Early and late adverse effects in normal tissues

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

    Measured: 5 years

  11. 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.

    Measured: 5 years

  12. 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.

    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 posted17 Dec 2020
  2. Study start4 Mar 2021
  3. Primary completion7 Dec 2025 (estimated)
  4. Study completion31 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669873
Sponsor's protocol ID
38341220.8.0000.0072
Acronym
LAPIDARY
Status last verified
Nov 2020
First submitted
4 Dec 2020
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

    PubMed 22019144

  • Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.

    PubMed 26494415

  • Polgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3.

    PubMed 23742961

  • Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11.

    PubMed 24225155

  • Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.

    PubMed 23835717

  • Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.

    PubMed 27866865

  • Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.

    PubMed 25605582

  • Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.

    PubMed 24055415

  • Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.

    PubMed 32663119

  • Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.

    PubMed 28779963

  • Imielinski K. [Sexuality and personality]. Ginekol Pol. 1981 Mar;52(3):293-7. No abstract available. Polish.

    PubMed 7262592

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: Standard, Experimental 1: Hypofractionated radiotherapy and Experimental 2: Accelerated Partial Breast Irradiation in people with Malignant Neoplasm of Breast, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Mar 2021. 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 Brazil. 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?

Contact Eduardo Barbieri (+551198639-1945, edurxt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of local recurrence (time frame: 5 years). 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 NCT04669873, which also lists 11 linked publications.

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 8 Mar 2021.

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