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Breast Cancer FemalePhase 2NCT05850637

Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

A Phase 2 study testing adjuvant ultra-hypofractionated radiotherapy in people with Breast Cancer Female, run by Prevent Senior Institute at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
adjuvant ultra-hypofractionated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
30 Jan 2019to 1 Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Female patient;
  • Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
  • Age greater than or equal to 65 years;
  • Breast-conserving surgery or mastectomy with or without axillary approach
  • With or without neoadjuvant or adjuvant systemic treatment

Who cannot join

  • Patients with previous thoracic irradiation;
  • Patients with indication for bilateral thoracic irradiation;
  • Patients with breast reconstruction with prosthesis or autologous tissue;
  • Patients with compromised surgical margins after resection;
  • pT1-pT2 pN0 patients undergoing radical mastectomy.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto de Pesquisa Prevent Senior

    São Paulo

Other trials in Brazil

About this study

Official title: Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Read the detailed description

Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Being tested
adjuvant ultra-hypofractionated radiotherapy
Keywords
Breast Cancer, Adjuvant radiotherapy, Ultra-hypofractionated
Medical subject headings
Breast Neoplasms

What participants receive

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

  • adjuvant ultra-hypofractionated radiotherapyRadiation

    adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer

Study groups in NCT05850637
Study groupRoleWhat they receive
Single Arm Ultra-hypofractionatedExperimental5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains
Receives: Radiation: adjuvant ultra-hypofractionated radiotherapy

What is being measured

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

  1. Acute toxicity

    Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0

    Measured: Events of radiotherapy up to 3 months

  2. Late toxicity

    Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.

    Measured: Events after 3 months of radiotherapy completion

Secondary outcomes (5)

  1. Locoregional free survival

    from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence

    Measured: 3 years

  2. Distant free survival

    from the date of initiation of treatment until the date of progression of distant disease evidence

    Measured: 3 years

  3. Overall survival

    defined from the date of initiation of treatment until the patient's death

    Measured: 3 years

  4. Cosmesis change

    was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up.

    1. Excellent: When compared to the untreated breast, there is no difference or minimal difference in the size or shape of the treated breast. The breast texture is the same or slightly different. There may be thickening, scar tissue, or fluid buildup in the breast, but not enough to change the appearance.
    2. Good: There is a slight difference in the size or shape of the treated breast compared to the untreated breast or compared to the original appearance of the treated breast. There may be a slight reddening or darkening of the breast. Thickening or scar tissue inside the breast causes only a slight change in shape or size.
    3. Fair: Obvious difference in the size and shape of the treated breast. This change involves a quarter or less of the breast. There may be

    Measured: week 10 and week 26 after the end of the treatment

  5. QOL (Quality of Life) changes

    was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start30 Jan 2019
  3. Primary completion11 Feb 2021
  4. Study completion1 Apr 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective phase 2 non-randomized single-arm study
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05850637
Sponsor's protocol ID
INSTITUTO PREVENT SENIOR - IPS
Status last verified
Apr 2024
First submitted
20 Apr 2023
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390

  • START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.

    PubMed 18355913

  • AMIN, M. B. et al. American Joint Committee on Cancer (AJCC). AJCC Cancer Staging Manual. [s.l: s.n.].

  • Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.

    PubMed 25500422

  • Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.

    PubMed 20879569

  • Collaborative Group on Hormonal Factors in Breast Cancer. Familial breast cancer: collaborative reanalysis of individual data from 52 epidemiological studies including 58,209 women with breast cancer and 101,986 women without the disease. Lancet. 2001 Oct 27;358(9291):1389-99. doi: 10.1016/S0140-6736(01)06524-2.

    PubMed 11705483

  • Bray F, McCarron P, Parkin DM. The changing global patterns of female breast cancer incidence and mortality. Breast Cancer Res. 2004;6(6):229-39. doi: 10.1186/bcr932. Epub 2004 Aug 26.

    PubMed 15535852

  • Brunt AM, Wheatley D, Yarnold J, Somaiah N, Kelly S, Harnett A, Coles C, Goodman A, Bahl A, Churn M, Zotova R, Sydenham M, Griffin CL, Morden JP, Bliss JM; FAST-Forward Trial Management Group. Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy compared with a standard 3-week regimen delivered in the UK FAST-Forward Trial. Radiother Oncol. 2016 Jul;120(1):114-8. doi: 10.1016/j.radonc.2016.02.027. Epub 2016 Apr 1.

    PubMed 27046390

  • 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

  • Chan EK, Woods R, Virani S, Speers C, Wai ES, Nichol A, McBride ML, Tyldesley S. Long-term mortality from cardiac causes after adjuvant hypofractionated vs. conventional radiotherapy for localized left-sided breast cancer. Radiother Oncol. 2015 Jan;114(1):73-8. doi: 10.1016/j.radonc.2014.08.021. Epub 2014 Sep 13.

    PubMed 25227961

  • Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

    PubMed 10963602

  • Ciammella P, Podgornii A, Galeandro M, Micera R, Ramundo D, Palmieri T, Cagni E, Iotti C. Toxicity and cosmetic outcome of hypofractionated whole-breast radiotherapy: predictive clinical and dosimetric factors. Radiat Oncol. 2014 Apr 24;9:97. doi: 10.1186/1748-717X-9-97.

    PubMed 24762173

  • Clavel-Chapelon F, Gerber M. Reproductive factors and breast cancer risk. Do they differ according to age at diagnosis? Breast Cancer Res Treat. 2002 Mar;72(2):107-15. doi: 10.1023/a:1014891216621.

    PubMed 12038701

  • Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.

    PubMed 7713792

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing adjuvant ultra-hypofractionated radiotherapy in people with Breast Cancer Female, run by Prevent Senior Institute 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Apr 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity (time frame: Events of radiotherapy up to 3 months). The study lists 2 primary outcomes in all. 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 NCT05850637, which also lists 80 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 4 Apr 2024.

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