Breast CancerNCT03616626
Whole Breast Irradiation vs Twice Daily vs. Once Daily Accelerated Partial Breast Irradiation
A study testing Once Daily APBI, Twice Daily APBI and Whole Breast Irradiation in people with Breast Cancer and Radiation Toxicity, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation Toxicity
- What is being tested?
- Once Daily APBI, Twice Daily APBI and Whole Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2013to 30 Jun 2021
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor characteristics
- Histologically confirmed invasive adenocarcinoma of the breast
- Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
- Hormone receptor status:
- Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery
- Tumor removed with conservative breast surgery with adequate margin
Show all 30Show fewer
- Re-excision of surgical margins allowed
- No prior breast implants
- Prior axillary staging required for patients including 1 of the following:
- Sentinel node biopsy alone (if sentinel node is negative)
- Sentinel node biopsy followed by axillary dissection if sentinel node is positive)
- Axillary dissection alone with ≥ 6 axillary nodes
- Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
- Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
- No prior biologic therapy for this malignancy Chemotherapy
- No prior chemotherapy for this malignancy
- No concurrent chemotherapy during study radiotherapy Endocrine therapy
- No prior hormonal therapy for this malignancy
- Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
- No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
- No concurrent hormone replacement therapy Radiotherapy
- No prior radiotherapy for this malignancy
- No prior breast or thoracic radiotherapy
- No concurrent regional nodal irradiation Other
- No other concurrent anticancer therapy Menopausal status
- Premenopausal or postmenopausal Performance status
- WHO 0-1 Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
Who cannot join
- Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
- Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
- Positive axillary nodes.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
- Paget's disease of the nipple
Show all 10Show fewer
- Previous history of invasive breast cancer or DCIS.
- Synchronous bilateral invasive or non-invasive breast cancer
- Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
- Psychiatric or addictive disorder that would preclude study therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized Study of Adjuvant Whole Breast Versus Partial Breast Irradiation Using Once Daily or Twice Daily Fractionation Scheme in Women With Stage I or II Breast Cancer
This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Read the detailed description
Women with invasive carcinoma of the breast less than 3 cm with negative axillary nodes , following BCS, who meet the inclusion criteria will be approached for potential study enrollment.
Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT WBI 50 Gy in 25 fractions over 5 weeks or APBI 38.5 Gy in 10 once daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85 Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists using the EORTC Breast Cosmetic Rating System. Radiation toxicity will be assessed using the NCI CTCAE version 4.0. The primary outcome is to compare the acute, late toxicities and adverse cosmetic outcomes at 6, 12 and 18 months among the three groups.
- Conditions
- Breast Cancer, Radiation Toxicity
- Being tested
- Once Daily APBI, Twice Daily APBI, Whole Breast Irradiation
- Keywords
- Breast Cancer, Accelerated partial Breast Irradiation, Breast cosmesis, radiation Toxicity
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once Daily APBIRadiation
Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks
Twice Daily APBIRadiation
Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week
Whole Breast IrradiationRadiation
Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years
| Study group | Role | What they receive |
|---|---|---|
| Whole Breast Irradiation | Active comparator | Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years Receives: Radiation: Whole Breast Irradiation |
| Once Daily APBI | Experimental | Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks Receives: Radiation: Once Daily APBI |
| Twice Daily APBI | Experimental | Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week Receives: Radiation: Twice Daily APBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
The primary outcome is the change in the adverse cosmesis assessed prior to radiation, 6, 12 and 18 months after end of radiation. The cosmetic outcome will be assessed by a radiation oncologist who is unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System.
Measured: prior to radiation, 6,12 and 18 months after radiation
Secondary outcomes (4)
Ipsilateral Breast Tumor Recurrence (IBTR)
defined as recurrent invasive or in situ cancer in the ipsilateral breast. Histological evidence of local recurrence will be required.
Measured: throughout the study up to 5 years
Disease Free Survival
defined as the time from randomization to the time of documented recurrent disease in the ipsilateral breast or regional nodes (supraclavicular, axillary or internal mammary) or distant sites (e.g. bone, liver, lung or brain).
Measured: throughout the study up to 5 years
Overall Survival
defined as the time from randomization to death from any cause
Measured: From date of randomization until the date of death up to 5 years
Radiation Induced Early and late toxicities
using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.0
Measured: during radiation and at 6, 12 and 18 months after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jul 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt
- Investigators
- Rimoun Boutrus, M.D., Principal investigator, Radiation Oncology Department, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616626
- Sponsor's protocol ID
- NCI-BC-12/2012
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
PubMed 19395195Jagsi R, Ben-David MA, Moran JM, Marsh RB, Griffith KA, Hayman JA, Pierce LJ. Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):71-8. doi: 10.1016/j.ijrobp.2009.01.041.
PubMed 19409733Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
PubMed 19910132Chen PY, Wallace M, Mitchell C, Grills I, Kestin L, Fowler A, Martinez A, Vicini F. Four-year efficacy, cosmesis, and toxicity using three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):991-7. doi: 10.1016/j.ijrobp.2009.03.012. Epub 2009 Jun 8.
PubMed 19515514Goyal S, Daroui P, Khan AJ, Kearney T, Kirstein L, Haffty BG. Three-year outcomes of a once daily fractionation scheme for accelerated partial breast irradiation (APBI) using 3-D conformal radiotherapy (3D-CRT). Cancer Med. 2013 Dec;2(6):964-71. doi: 10.1002/cam4.157. Epub 2013 Oct 31.
PubMed 24403270DE Paula U, D'Angelillo RM, Barbara R, Caruso C, Gomellini S, Caccavari A, Costarelli L, Scavina P, Mauri M, Santini E, Antonaci A, Cavaliere F, LA Pinta M, Loreti A, Fortunato L. Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical Tomotherapy(R). Anticancer Res. 2016 Jun;36(6):3035-9.
PubMed 27272823Bentzen SM, Yarnold JR. Reports of unexpected late side effects of accelerated partial breast irradiation--radiobiological considerations. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):969-73. doi: 10.1016/j.ijrobp.2010.01.059. No abstract available.
PubMed 20610037
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Adjuvant Whole Breast Versus Partial Breast Irradiation Using Once Daily or Twice Daily Fractionation Scheme in Women With Stage I or II Breast Cancer
- ClinicalTrials.gov ID
- NCT03616626
- Acronym / sponsor ID
- NCI-BC-12/2012
- Conditions
- Breast Cancer, Radiation Toxicity
- Keywords
- Breast Cancer, Accelerated partial Breast Irradiation, Breast cosmesis, radiation Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Aug 2018 (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.
This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Detailed description
Women with invasive carcinoma of the breast less than 3 cm with negative axillary nodes , following BCS, who meet the inclusion criteria will be approached for potential study enrollment.
Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT WBI 50 Gy in 25 fractions over 5 weeks or APBI 38.5 Gy in 10 once daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85 Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists using the EORTC Breast Cosmetic Rating System. Radiation toxicity will be assessed using the NCI CTCAE version 4.0. The primary outcome is to compare the acute, late toxicities and adverse cosmetic outcomes at 6, 12 and 18 months among the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole Breast Irradiation | Active comparator | Radiation: Whole Breast IrradiationAdjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years |
| Once Daily APBI | Experimental | Radiation: Once Daily APBIAdjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks |
| Twice Daily APBI | Experimental | Radiation: Twice Daily APBIAdjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Tumor characteristics
- Histologically confirmed invasive adenocarcinoma of the breast
- Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
- Hormone receptor status:
- Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery
Key exclusion criteria (10 listed)
- Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
- Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
- Positive axillary nodes.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
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 |
|---|---|---|
| Once Daily APBIAdjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks | Radiation | Once Daily APBI |
| Twice Daily APBIAdjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week | Radiation | Twice Daily APBI |
| Whole Breast IrradiationAdjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years | Radiation | Whole Breast Irradiation |
Primary outcome
Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
Time frame: prior to radiation, 6,12 and 18 months after radiation
The primary outcome is the change in the adverse cosmesis assessed prior to radiation, 6, 12 and 18 months after end of radiation. The cosmetic outcome will be assessed by a radiation oncologist who is unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System.
4 secondary outcomes
Ipsilateral Breast Tumor Recurrence (IBTR)
Time frame: throughout the study up to 5 years
Disease Free Survival
Time frame: throughout the study up to 5 years
Overall Survival
Time frame: From date of randomization until the date of death up to 5 years
Radiation Induced Early and late toxicities
Time frame: during radiation and at 6, 12 and 18 months after radiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Results publication: PubMed 19395195Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
- Results publication: PubMed 19409733Jagsi R, Ben-David MA, Moran JM, Marsh RB, Griffith KA, Hayman JA, Pierce LJ. Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):71-8. doi: 10.1016/j.ijrobp.2009.01.041.
- Results publication: PubMed 19910132Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
- Results publication: PubMed 19515514Chen PY, Wallace M, Mitchell C, Grills I, Kestin L, Fowler A, Martinez A, Vicini F. Four-year efficacy, cosmesis, and toxicity using three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):991-7. doi: 10.1016/j.ijrobp.2009.03.012. Epub 2009 Jun 8.
- Results publication: PubMed 24403270Goyal S, Daroui P, Khan AJ, Kearney T, Kirstein L, Haffty BG. Three-year outcomes of a once daily fractionation scheme for accelerated partial breast irradiation (APBI) using 3-D conformal radiotherapy (3D-CRT). Cancer Med. 2013 Dec;2(6):964-71. doi: 10.1002/cam4.157. Epub 2013 Oct 31.
- Results publication: PubMed 27272823DE Paula U, D'Angelillo RM, Barbara R, Caruso C, Gomellini S, Caccavari A, Costarelli L, Scavina P, Mauri M, Santini E, Antonaci A, Cavaliere F, LA Pinta M, Loreti A, Fortunato L. Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical Tomotherapy(R). Anticancer Res. 2016 Jun;36(6):3035-9.
- Results publication: PubMed 20610037Bentzen SM, Yarnold JR. Reports of unexpected late side effects of accelerated partial breast irradiation--radiobiological considerations. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):969-73. doi: 10.1016/j.ijrobp.2010.01.059. No abstract available.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Rimoun Boutrus, M.D. principal investigator
Radiation Oncology Department, National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once Daily APBI, Twice Daily APBI and Whole Breast Irradiation in people with Breast Cancer and Radiation Toxicity, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 30 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. 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 Egypt. 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?
Results are not available in the source record.
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?
Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System (time frame: prior to radiation, 6,12 and 18 months after radiation). 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 NCT03616626, which also lists 7 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 28 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.