Breast CancerPROMARTNCT05491395
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction
A study testing Hypofractionation in people with Breast Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
RATIONALE: Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jun 2022to 1 May 2029
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with confirmed histological diagnosis of invasive ductal carcinoma and lobular breast carcinoma;
- Radical mastectomy with immediate reconstruction with a prosthesis;
- Patients indicated for adjuvant RT;
- Any lymph node status;
- With or without adjuvant chemotherapy;
- ECOG performance status from 0-2;
- > 18 years old;
- Informed Consent Form applied before any study-specific procedure.
Who cannot join
- Another histological diagnosis than invasive ductal carcinoma or lobular carcinoma;
- Previous history of neoplasm and/or radiotherapy and/ or quimiotherapy before this study;
- Distant metastatic disease;
- Palliative treatment;
- Patients with scleroderma / systemic lupus erythematosus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Radiation Oncology Department
Barretos, São Paulo, 14784-400
Marcos D Mattos, MD, MS, +5517981140230, marcosbtos3@gmail.com
Alexandre A Jacinto, MD, PhD, +551733216600 ext. 7342, jacintoaa@gmail.com
About this study
Official title: Randomized Phase III Clinical Trial of Hypofractionated Radiotherapy in Breast Cancer Patients With Immediate Prosthetic Reconstruction: PROMART Trial
RATIONALE:
Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome.
Read more
There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis.
PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.
Read the detailed description
General aim: To evaluated if hypofractionated accelerated radiotherapy in patients with breast cancer undergoing immediate breast implant reconstruction surgery is non inferior to conventional radiotherapy.
Aim 1 (Primary objective): Assess the G3 toxicity rate - loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning).
Aim 2 (Specific secondary objectives):
- Compare local recurrence rate between two groups;
- Compare quality of life index between two groups using EORTC QLQ-C30 / EORTC QLQ-BR45 scales during treatment, after 6 and 12 months after treatment ending;
- Compare self-image differences between groups;
- Compare acute and late radiodermatitis rates by CTCAE 4.0;
- Analyse dosimetric planning differences considering the volumes of all breast and breast without prosthesis;
- Study inflammation molecular markers, which may indicate an increased risk of fibrosis;
- Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional;
- Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts.
- Conditions
- Breast Cancer
- Being tested
- Hypofractionation
- Keywords
- breast cancer, radiation therapy, hypofractionated, biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypofractionationRadiation
Hypofractionation scheme will comprise 40 Gy in 15 fractions
| Study group | Role | What they receive |
|---|---|---|
| Post Mastectomy Hypofractionated Radiotherapy Arm | Experimental | Post Mastectomy Hypofractionated Radiotherapy Arm Receives: Radiation: Hypofractionation |
| Post Mastectomy Conventional Radiotherapy | No intervention | Post Mastectomy Conventional Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the G3 toxicity rate
loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)
Measured: 2 years
Secondary outcomes (8)
Local recurrence
Compare local recurrence rate between two groups
Measured: 5 years
Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Compare quality of life index between two groups using EORTC scales during treatment, after 6 and 12 months after treatment ending
Measured: 2 years
Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Compare self-image differences between groups
Measured: 5 years
Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Acute and late radiodermatitis rateswill be evaluated by CTCAE 4.0 scale, using the adverse event (AE) reporting. A grading (severity) scale is provided for each AE term.
Measured: 2 years
Dosimetric analysis
Analyze dosimetric planning differences considering the volumes of all breast and breast without prosthesis
Measured: 5 years
Inflammation markers screening - detection of cytokines with the CBA panel
Study inflammation molecular markers, which may indicate an increased risk of fibrosis. The cytokines present in the plasma will be evaluated using the Cytometric Beads Array technique with the CBA panel - Human Th1/Th2/Th17CBAKit which, through beads, is able to identify the expression of cytokines expressed by Th1, Th2 standard lymphocytes and Th17, including IL-2, IL-4, IL-6, IL-10, IL-17A, TNF e IFN-γ. After proper labeling, the immunophenotypic analyzes will be performed in a BD FAC Symphony flow cytometer.
Measured: 3 years
Extracellular vesicles isolation and characterization
Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional
Measured: 4 years
Evaluate extracellular vesicles molecular profile
Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start27 Jun 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Arm Experimental: Post Mastectomy Hypofractionated Radiotherapy Arm No Intervention: Post Mastectomy Conventional Radiotherapy
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcos D Mattos, MD, MS, Principal investigator, Barretos Cancer HospitalGabriela B Salvador, BS, Study chair, Barretos Cancer HospitalWanessa F Altei, PhD, Study chair, Barretos Cancer HospitalLais L Almeida, MD, Study chair, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491395
- Sponsor's protocol ID
- 1
- Acronym
- PROMART
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halsted WS. I. The Results of Operations for the Cure of Cancer of the Breast Performed at the Johns Hopkins Hospital from June, 1889, to January, 1894. Ann Surg. 1894 Nov;20(5):497-555. doi: 10.1097/00000658-189407000-00075. No abstract available.
PubMed 17860107Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E, Muscolino G, Rilke F, Salvadori B, Zecchini A, Zucali R. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981 Jul 2;305(1):6-11. doi: 10.1056/NEJM198107023050102.
PubMed 7015141Song SY, Chang JS, Fan KL, Kim MJ, Chang HP, Lew DH, Roh TS, Roh H, Kim YB, Lee DW. Hypofractionated Radiotherapy With Volumetric Modulated Arc Therapy Decreases Postoperative Complications in Prosthetic Breast Reconstructions: A Clinicopathologic Study. Front Oncol. 2020 Nov 17;10:577136. doi: 10.3389/fonc.2020.577136. eCollection 2020.
PubMed 33282731Liu L, Yang Y, Guo Q, Ren B, Peng Q, Zou L, Zhu Y, Tian Y. Comparing hypofractionated to conventional fractionated radiotherapy in postmastectomy breast cancer: a meta-analysis and systematic review. Radiat Oncol. 2020 Jan 17;15(1):17. doi: 10.1186/s13014-020-1463-1.
PubMed 31952507SBRT, Brazilian Society of Radiotherapy; Freitas NMA, Rosa AA, Marta GN, Hanna SA, Hanriot RM, Borges ABB, Gondim GRM, Pellizzon ACA, Veras IM, Almeida Junior WJ, Fernandez CRSHW, Batalha Filho ES, Castilho MS, Kuhnen FQ, Najas RMXF, Affonso Junior RJ, Leite ACC, Ribeiro HLM, Freitas Junior R, Oliveira HF. Recommendations for hypofractionated whole-breast irradiation. Rev Assoc Med Bras (1992). 2018 Sep;64(9):770-777. doi: 10.1590/1806-9282.64.09.770.
PubMed 30672995Van Poznak C, Somerfield MR, Bast RC, Cristofanilli M, Goetz MP, Gonzalez-Angulo AM, Hicks DG, Hill EG, Liu MC, Lucas W, Mayer IA, Mennel RG, Symmans WF, Hayes DF, Harris LN. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2015 Aug 20;33(24):2695-704. doi: 10.1200/JCO.2015.61.1459. Epub 2015 Jul 20.
PubMed 26195705Nimeus-Malmstrom E, Krogh M, Malmstrom P, Strand C, Fredriksson I, Karlsson P, Nordenskjold B, Stal O, Ostberg G, Peterson C, Ferno M. Gene expression profiling in primary breast cancer distinguishes patients developing local recurrence after breast-conservation surgery, with or without postoperative radiotherapy. Breast Cancer Res. 2008;10(2):R34. doi: 10.1186/bcr1997. Epub 2008 Apr 22.
PubMed 18430221Tramm T, Kyndi M, Myhre S, Nord S, Alsner J, Sorensen FB, Sorlie T, Overgaard J. Relationship between the prognostic and predictive value of the intrinsic subtypes and a validated gene profile predictive of loco-regional control and benefit from post-mastectomy radiotherapy in patients with high-risk breast cancer. Acta Oncol. 2014 Oct;53(10):1337-46. doi: 10.3109/0284186X.2014.925580. Epub 2014 Jun 24.
PubMed 24957550Kowal J, Arras G, Colombo M, Jouve M, Morath JP, Primdal-Bengtson B, Dingli F, Loew D, Tkach M, Thery C. Proteomic comparison defines novel markers to characterize heterogeneous populations of extracellular vesicle subtypes. Proc Natl Acad Sci U S A. 2016 Feb 23;113(8):E968-77. doi: 10.1073/pnas.1521230113. Epub 2016 Feb 8.
PubMed 26858453Yin Z, Yu M, Ma T, Zhang C, Huang S, Karimzadeh MR, Momtazi-Borojeni AA, Chen S. Mechanisms underlying low-clinical responses to PD-1/PD-L1 blocking antibodies in immunotherapy of cancer: a key role of exosomal PD-L1. J Immunother Cancer. 2021 Jan;9(1):e001698. doi: 10.1136/jitc-2020-001698.
PubMed 33472857Back M, Guerrieri M, Wratten C, Steigler A. Impact of radiation therapy on acute toxicity in breast conservation therapy for early breast cancer. Clin Oncol (R Coll Radiol). 2004 Feb;16(1):12-6. doi: 10.1016/j.clon.2003.08.005.
PubMed 14768750
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Clinical Trial of Hypofractionated Radiotherapy in Breast Cancer Patients With Immediate Prosthetic Reconstruction: PROMART Trial
- ClinicalTrials.gov ID
- NCT05491395
- Acronym / sponsor ID
- PROMART / 1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiation therapy, hypofractionated, biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE:
Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome.
There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis.
PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.
Detailed description
General aim: To evaluated if hypofractionated accelerated radiotherapy in patients with breast cancer undergoing immediate breast implant reconstruction surgery is non inferior to conventional radiotherapy.
Aim 1 (Primary objective): Assess the G3 toxicity rate - loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning).
Aim 2 (Specific secondary objectives):
- Compare local recurrence rate between two groups;
- Compare quality of life index between two groups using EORTC QLQ-C30 / EORTC QLQ-BR45 scales during treatment, after 6 and 12 months after treatment ending;
- Compare self-image differences between groups;
- Compare acute and late radiodermatitis rates by CTCAE 4.0;
- Analyse dosimetric planning differences considering the volumes of all breast and breast without prosthesis;
- Study inflammation molecular markers, which may indicate an increased risk of fibrosis;
- Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional;
- Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm Experimental: Post Mastectomy Hypofractionated Radiotherapy Arm No Intervention: Post Mastectomy Conventional Radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Post Mastectomy Hypofractionated Radiotherapy Arm | Experimental | Radiation: HypofractionationPost Mastectomy Hypofractionated Radiotherapy Arm |
| Post Mastectomy Conventional Radiotherapy | No intervention | –Post Mastectomy Conventional Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with confirmed histological diagnosis of invasive ductal carcinoma and lobular breast carcinoma;
- Radical mastectomy with immediate reconstruction with a prosthesis;
- Patients indicated for adjuvant RT;
- Any lymph node status;
- With or without adjuvant chemotherapy;
Key exclusion criteria (5 listed)
- Another histological diagnosis than invasive ductal carcinoma or lobular carcinoma;
- Previous history of neoplasm and/or radiotherapy and/ or quimiotherapy before this study;
- Distant metastatic disease;
- Palliative treatment;
- Patients with scleroderma / systemic lupus erythematosus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypofractionationHypofractionation scheme will comprise 40 Gy in 15 fractions | Radiation | Post Mastectomy Hypofractionated Radiotherapy Arm |
Primary outcome
Assess the G3 toxicity rate
Time frame: 2 years
loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)
8 secondary outcomes
Local recurrence
Time frame: 5 years
Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Time frame: 2 years
Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Time frame: 5 years
Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time frame: 2 years
Dosimetric analysis
Time frame: 5 years
Inflammation markers screening - detection of cytokines with the CBA panel
Time frame: 3 years
Extracellular vesicles isolation and characterization
Time frame: 4 years
Evaluate extracellular vesicles molecular profile
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 17860107Halsted WS. I. The Results of Operations for the Cure of Cancer of the Breast Performed at the Johns Hopkins Hospital from June, 1889, to January, 1894. Ann Surg. 1894 Nov;20(5):497-555. doi: 10.1097/00000658-189407000-00075. No abstract available.
- Background: PubMed 7015141Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E, Muscolino G, Rilke F, Salvadori B, Zecchini A, Zucali R. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981 Jul 2;305(1):6-11. doi: 10.1056/NEJM198107023050102.
- Background: PubMed 33282731Song SY, Chang JS, Fan KL, Kim MJ, Chang HP, Lew DH, Roh TS, Roh H, Kim YB, Lee DW. Hypofractionated Radiotherapy With Volumetric Modulated Arc Therapy Decreases Postoperative Complications in Prosthetic Breast Reconstructions: A Clinicopathologic Study. Front Oncol. 2020 Nov 17;10:577136. doi: 10.3389/fonc.2020.577136. eCollection 2020.
- Background: PubMed 31952507Liu L, Yang Y, Guo Q, Ren B, Peng Q, Zou L, Zhu Y, Tian Y. Comparing hypofractionated to conventional fractionated radiotherapy in postmastectomy breast cancer: a meta-analysis and systematic review. Radiat Oncol. 2020 Jan 17;15(1):17. doi: 10.1186/s13014-020-1463-1.
- Background: PubMed 30672995SBRT, Brazilian Society of Radiotherapy; Freitas NMA, Rosa AA, Marta GN, Hanna SA, Hanriot RM, Borges ABB, Gondim GRM, Pellizzon ACA, Veras IM, Almeida Junior WJ, Fernandez CRSHW, Batalha Filho ES, Castilho MS, Kuhnen FQ, Najas RMXF, Affonso Junior RJ, Leite ACC, Ribeiro HLM, Freitas Junior R, Oliveira HF. Recommendations for hypofractionated whole-breast irradiation. Rev Assoc Med Bras (1992). 2018 Sep;64(9):770-777. doi: 10.1590/1806-9282.64.09.770.
- Background: PubMed 26195705Van Poznak C, Somerfield MR, Bast RC, Cristofanilli M, Goetz MP, Gonzalez-Angulo AM, Hicks DG, Hill EG, Liu MC, Lucas W, Mayer IA, Mennel RG, Symmans WF, Hayes DF, Harris LN. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2015 Aug 20;33(24):2695-704. doi: 10.1200/JCO.2015.61.1459. Epub 2015 Jul 20.
- Background: PubMed 18430221Nimeus-Malmstrom E, Krogh M, Malmstrom P, Strand C, Fredriksson I, Karlsson P, Nordenskjold B, Stal O, Ostberg G, Peterson C, Ferno M. Gene expression profiling in primary breast cancer distinguishes patients developing local recurrence after breast-conservation surgery, with or without postoperative radiotherapy. Breast Cancer Res. 2008;10(2):R34. doi: 10.1186/bcr1997. Epub 2008 Apr 22.
- Background: PubMed 24957550Tramm T, Kyndi M, Myhre S, Nord S, Alsner J, Sorensen FB, Sorlie T, Overgaard J. Relationship between the prognostic and predictive value of the intrinsic subtypes and a validated gene profile predictive of loco-regional control and benefit from post-mastectomy radiotherapy in patients with high-risk breast cancer. Acta Oncol. 2014 Oct;53(10):1337-46. doi: 10.3109/0284186X.2014.925580. Epub 2014 Jun 24.
- Background: PubMed 26858453Kowal J, Arras G, Colombo M, Jouve M, Morath JP, Primdal-Bengtson B, Dingli F, Loew D, Tkach M, Thery C. Proteomic comparison defines novel markers to characterize heterogeneous populations of extracellular vesicle subtypes. Proc Natl Acad Sci U S A. 2016 Feb 23;113(8):E968-77. doi: 10.1073/pnas.1521230113. Epub 2016 Feb 8.
- Background: PubMed 33472857Yin Z, Yu M, Ma T, Zhang C, Huang S, Karimzadeh MR, Momtazi-Borojeni AA, Chen S. Mechanisms underlying low-clinical responses to PD-1/PD-L1 blocking antibodies in immunotherapy of cancer: a key role of exosomal PD-L1. J Immunother Cancer. 2021 Jan;9(1):e001698. doi: 10.1136/jitc-2020-001698.
- Background: PubMed 14768750Back M, Guerrieri M, Wratten C, Steigler A. Impact of radiation therapy on acute toxicity in breast conservation therapy for early breast cancer. Clin Oncol (R Coll Radiol). 2004 Feb;16(1):12-6. doi: 10.1016/j.clon.2003.08.005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcos D Mattos, MD, MS principal investigator
Barretos Cancer Hospital
Gabriela B Salvador, BS study chair
Barretos Cancer Hospital
Wanessa F Altei, PhD study chair
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionation in people with Breast Cancer, run by Barretos Cancer Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 8 Aug 2022. 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 Marcos D Mattos, MD, MS (+5517981140230, marcosbtos3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the G3 toxicity rate (time frame: 2 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 NCT05491395, 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 Aug 2022.