Breast Cancer FemaleNCT04148586
Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer
A study testing Whole Breast Irradiation in people with Breast Cancer Female, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Whole Breast Irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Mar 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tis, pT1-2, pN0-1, M0 disease
- Invasive carcinoma of the breast or ductal carcinoma insitu [DCIS]
- CBS (reconstruction is not allowed)
- Negative surgical margin
- Axillary staging \&/or dissection
Who cannot join
- pT3-4, pN2-3 breast cancer
- Inadequate axillary lymph node dissection
- Neoadjuvant chemotherapy
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Synchronous bilateral invasive or non-invasive breast cancer
- History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
Show all 13Show fewer
- Past history of malignancy except
- Basal cell skin cancer
- CIN cervix uteri
- Cosmetic breast implants (Patients who have had implants removed are eligible.)
- Prior breast or thoracic RT for any condition
- Collagen vascular disease, specifically systemic lupus, or scleroderma
- Pregnancy or lactation at the time of radiotherapy. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer
The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.
Read the detailed description
- Radiotherapy Timing If the patient is not receiving chemotherapy, WBI is to be initiated within 9 weeks following lumpectomy or re-excision of margins. For patients receiving chemotherapy, WBI is to begin no fewer than 2 weeks and no more than 8 weeks after the last cycle of chemotherapy.
- Randomization:
138 patients will be randomized using permuted blocks randomization to 3 equal comparable arms.
- Dose Prescriptions
Arm 1:
One week WBI: 27Gy/5 fractions /1 week. 5.4 Gy/fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.
Arm 2:
Once weekly WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.
Arm 3:
Hypofractionated WBI 40 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI.
3-Tumor bed boost A tumor bed boost is recommended to high-risk patients [Age < 50 years, high grade] according to the National Comprehensive Cancer Network (NCCN) guidelines.
4-Radiotherapy simulation, Localization and Outlining:
- The guidelines for contouring will conform to the policies set by the Radiation Therapy Oncology Group (RTOG) Breast cancer Atlas. www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx
- Megavoltage ( MV) photon beams with energies ≥ 6 MV are required.
- Radiotherapy Planning:
Computed tomography based conformal radiotherapy (CT-based 3D-CRT) planning with tissue inhomogeneity correction is required .
5- Systemic Therapy
- Chemotherapy Adjuvant chemotherapy may be given at the discretion of the patient's medical oncologist. The use of chemotherapeutic agents during radiation therapy is not allowed. The use of neoadjuvant chemotherapy is not allowed.
- Hormonal therapy Patients with ER-positive and/or PR-positive tumors should be treated with hormonal therapy for a minimum of 5 years. The use of hormonal therapy during radiation therapy is allowed.
- Trastuzumab Trastuzumab is given to HER2 positive patients. The use of Trastuzumab during radiation therapy is allowed. 6-Surgical Treatment:
- All patients will undergo CBS, axillary staging and/or dissection with negative surgical margins (sm).
- Negative surgical margin (Curigliano, 2017)
- Invasive breast cancer: no ink on tumor
- DCIS: 2mm
- Surgical clips will be used to define the tumor bed borders
- Breast reconstruction and cosmetic breast implants are not allowed 7-Follow-up.
Schedule of Follow up:
- History and physical exam for all randomized patients will occur every 3 months in the first 2 years after the date of end of radiotherapy treatment
- Monitor and refer for lymphedema management.
- Mammography will be requested annually
- Conditions
- Breast Cancer Female
- Being tested
- Whole Breast Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Breast IrradiationOther
Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer
| Study group | Role | What they receive |
|---|---|---|
| One week Whole Breast Irradiation | Experimental | WBI: 27 Gy/5 fractions/1 week. 5.4 Gy /fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI. Receives: Other: Whole Breast Irradiation |
| Once weekly Whole Breast Irradiation | Experimental | WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week. Receives: Other: Whole Breast Irradiation |
| 3 weeks Whole Breast Irradiation | Active comparator | WBI: 40.05 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI Receives: Other: Whole Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
The proportion of patients with grade ≥3 toxicity according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria.
Measured: 3 months from the start of whole breast irradiation
Cosmetic outcome
measured by The European Organisation for Research and Treatment of Cancer (EORTC) breast cosmetic rating system (observer rating)
Measured: Annually after the end of whole breast irradiation for 5 years
Ibsilateral locoregional tumor control
must be confirmed by cytological/ histological assessment
Measured: Annually after the end of whole breast irradiation for 5 years.
patient-reported outcome measures (PROMs)
measured by The European Organisation for Research and Treatment of Cancer, EORTC Quality of Life questionnaire for breast cancer patients ( EORTC QLQ-BR 23).
Measured: Annually after the end of whole breast irradiation for 5 years.
Secondary outcomes (3)
late toxicity
Late toxicity according to The Radiation Therapy Oncology Group/ The European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring schema
Measured: Annually after the end of whole breast irradiation for 5 years.
Distant disease-free survival
Defined as the time from initial diagnosis of breast cancer to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer.
Measured: 5 years from the initial diagnosis of breast cancer
Overall survival
Defined as the time from initial diagnosis of breast cancer to date of death or last follow up.
Measured: 5 years from the initial diagnosis of breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Nov 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa M El Awadly, Principal investigator, National Cancer Institute, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148586
- Sponsor's protocol ID
- 201617090.3
- Status last verified
- Sep 2020
- First submitted
- 18 Feb 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing plan includes study protocol, statistical analysis plan, informed consent form and clinical study report.
Publications
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• Fast forward protocol, Version 3.0: 08/07/2015: https://njl-admin.nihr.ac.uk/document/download/2006786.
FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.
PubMed 21752481Haviland 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 24055415Dragun AE, Ajkay NJ, Riley EC, Roberts TL, Pan J, Rai SN, Jain D, Quillo AR, Scoggins CR, McMasters KM, Woo SY. First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):595-602. doi: 10.1016/j.ijrobp.2017.01.212.
PubMed 28581400
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04148586
- Acronym / sponsor ID
- 201617090.3
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Nov 2019 (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.
The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.
Detailed description
- Radiotherapy Timing If the patient is not receiving chemotherapy, WBI is to be initiated within 9 weeks following lumpectomy or re-excision of margins. For patients receiving chemotherapy, WBI is to begin no fewer than 2 weeks and no more than 8 weeks after the last cycle of chemotherapy.
- Randomization:
138 patients will be randomized using permuted blocks randomization to 3 equal comparable arms.
- Dose Prescriptions
Arm 1:
One week WBI: 27Gy/5 fractions /1 week. 5.4 Gy/fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.
Arm 2:
Once weekly WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.
Arm 3:
Hypofractionated WBI 40 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI.
3-Tumor bed boost A tumor bed boost is recommended to high-risk patients [Age < 50 years, high grade] according to the National Comprehensive Cancer Network (NCCN) guidelines.
4-Radiotherapy simulation, Localization and Outlining:
- The guidelines for contouring will conform to the policies set by the Radiation Therapy Oncology Group (RTOG) Breast cancer Atlas. www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx
- Megavoltage ( MV) photon beams with energies ≥ 6 MV are required.
- Radiotherapy Planning:
Computed tomography based conformal radiotherapy (CT-based 3D-CRT) planning with tissue inhomogeneity correction is required .
5- Systemic Therapy
- Chemotherapy Adjuvant chemotherapy may be given at the discretion of the patient's medical oncologist. The use of chemotherapeutic agents during radiation therapy is not allowed. The use of neoadjuvant chemotherapy is not allowed.
- Hormonal therapy Patients with ER-positive and/or PR-positive tumors should be treated with hormonal therapy for a minimum of 5 years. The use of hormonal therapy during radiation therapy is allowed.
- Trastuzumab Trastuzumab is given to HER2 positive patients. The use of Trastuzumab during radiation therapy is allowed. 6-Surgical Treatment:
- All patients will undergo CBS, axillary staging and/or dissection with negative surgical margins (sm).
- Negative surgical margin (Curigliano, 2017)
- Invasive breast cancer: no ink on tumor
- DCIS: 2mm
- Surgical clips will be used to define the tumor bed borders
- Breast reconstruction and cosmetic breast implants are not allowed 7-Follow-up.
Schedule of Follow up:
- History and physical exam for all randomized patients will occur every 3 months in the first 2 years after the date of end of radiotherapy treatment
- Monitor and refer for lymphedema management.
- Mammography will be requested annually
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One week Whole Breast Irradiation | Experimental | Other: Whole Breast IrradiationWBI: 27 Gy/5 fractions/1 week. 5.4 Gy /fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI. |
| Once weekly Whole Breast Irradiation | Experimental | Other: Whole Breast IrradiationWBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week. |
| 3 weeks Whole Breast Irradiation | Active comparator | Other: Whole Breast IrradiationWBI: 40.05 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tis, pT1-2, pN0-1, M0 disease
- Invasive carcinoma of the breast or ductal carcinoma insitu [DCIS]
- CBS (reconstruction is not allowed)
- Negative surgical margin
- Axillary staging \&/or dissection
Key exclusion criteria (13 listed)
- pT3-4, pN2-3 breast cancer
- Inadequate axillary lymph node dissection
- Neoadjuvant chemotherapy
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Synchronous bilateral invasive or non-invasive breast cancer
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 |
|---|---|---|
| Whole Breast IrradiationWhole Breast Irradiation after CBS in females with DCIS and early stage breast cancer | Other | 3 weeks Whole Breast Irradiation, Once weekly Whole Breast Irradiation, One week Whole Breast Irradiation |
Primary outcome
Acute toxicity
Time frame: 3 months from the start of whole breast irradiation
The proportion of patients with grade ≥3 toxicity according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria.
Cosmetic outcome
Time frame: Annually after the end of whole breast irradiation for 5 years
measured by The European Organisation for Research and Treatment of Cancer (EORTC) breast cosmetic rating system (observer rating)
Ibsilateral locoregional tumor control
Time frame: Annually after the end of whole breast irradiation for 5 years.
must be confirmed by cytological/ histological assessment
patient-reported outcome measures (PROMs)
Time frame: Annually after the end of whole breast irradiation for 5 years.
measured by The European Organisation for Research and Treatment of Cancer, EORTC Quality of Life questionnaire for breast cancer patients ( EORTC QLQ-BR 23).
3 secondary outcomes
late toxicity
Time frame: Annually after the end of whole breast irradiation for 5 years.
Distant disease-free survival
Time frame: 5 years from the initial diagnosis of breast cancer
Overall survival
Time frame: 5 years from the initial diagnosis of breast cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Results publication: PubMed 27046390Brunt 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.
- Results publication• Fast forward protocol, Version 3.0: 08/07/2015: https://njl-admin.nihr.ac.uk/document/download/2006786.
- Results publication: PubMed 21752481FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.
- Results publication: PubMed 24055415Haviland 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.
- Results publication: PubMed 28581400Dragun AE, Ajkay NJ, Riley EC, Roberts TL, Pan J, Rai SN, Jain D, Quillo AR, Scoggins CR, McMasters KM, Woo SY. First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):595-602. doi: 10.1016/j.ijrobp.2017.01.212.
- Individual participant dataSharing planned: Yes. Sharing plan includes study protocol, statistical analysis plan, informed consent form and clinical study report.
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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.
Marwa M El Awadly principal investigator
National Cancer Institute, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Breast Irradiation in people with Breast Cancer Female, 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 5 inclusion and 13 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 16 Sep 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?
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: 3 months from the start of whole breast irradiation). The study lists 4 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 NCT04148586, which also lists 5 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 16 Sep 2020.