Breast Neoplasm FemalePhase 3NCT05417516
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
A Phase 3 study testing Whole Breast Irradiation (WBI) and Partial Breast Irradiation (PBI) in people with Breast Neoplasm Female and Radiotherapy, run by Ontario Clinical Oncology Group (OCOG) at 31 sites in 2 countries.
Trial summary
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization. Read more about this study
- Who is it for?
- Ages 50 to 120 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Radiotherapy, Cosmetic Outcome
- What is being tested?
- Whole Breast Irradiation (WBI) and Partial Breast Irradiation (PBI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 20 Nov 2023to Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in this study, patients must fulfill all of the following criteria:
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
- Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours <= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Who cannot join
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size >3cm in greatest diameter on pathological examination.
- Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
- Evidence of a DCIS component > 3cm
Show all 13Show fewer
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
Trial locations and contacts
31 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 2 countries
Canada19 sites, 19 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario
Sujata Pokhrel, pokhrels@rvh.on.ca
Christine DiMarco, dimarcoc@rvh.on.ca
- Recruiting
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
Calgary, Alberta
Payal Thakker, payal.thakkar@ahs.ca
Marny Yar, marny.yar@ahs.ca
- Recruiting
CSSS Champlain - Charles LeMoyne
Greenfield Park, Quebec
Lorraine Menard, lorraine.menard.cisssmc16@ssss.gouv.qc.ca
Marjory Jolicoeur, MD
- Recruiting
QEII HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia
Jessica Boddy, jessica.boddy@nshealth.ca
Maureen Nolan
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Kaelyn Ridgway, ridgwayk@hhsc.ca
Kunj Patel, patelkun@hhsc.ca
- Recruiting
London Regional Cancer Centre
London, Ontario
Amanda Anderson, Amanda.Anderson@lhsc.on.ca
Francisco Perera, MD
- Recruiting
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, H2L 4M1
Camille Paquet, 514-890-8000, camille.paquet.rech.chum@ssss.gouv.qc.ca
Siew Siew Pan, siew.siew.pan.chum@ssss.gouv.qc.ca
- Recruiting
McGill University Health Centre
Montreal, Quebec
Marianna Perna, marianna.perna@muhc.mcgill.ca
Tatiana Carvalho, tatana.carvalho@muhc.mcgill.ca
- Recruiting
Stronach (Southlake) Regional Health Centre
Newmarket, Ontario
Rachel Woo, RWoo@southlake.ca
Kendra, KSinnesael@southlake.ca
- Recruiting
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec
Josee Allard, Josee.Allard@chudequebec.ca
Valerie Theberge
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Shavaun Liss, 306-655-0641, shavaun.liss@saskcancer.ca
Savannah Drapak, 306-655-2461, savannah.drapak@saskcancer.ca
- Recruiting
Algoma District Cancer Program
Sault Ste. Marie, Ontario
Natalie Walde, walden@sah.on.ca
Stephane Thibodeau
- Recruiting
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, J1H5N4
Cynthia Ladouceur, 819-346-1110 ext. 13250, cynthia.ladouceur.ciussse-chus@ssss.gouv.qc.ca
Hélène Dion, 819-346-1110, helene.dion.ciussse-chus@ssss.gouv.qc.ca
- Recruiting
Princess Margaret Hospital
Toronto, Ontario
Lea Dungao, lea.dungao@rmp.uhn.on.ca
Jennifer Croke
- Recruiting
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario
Clarissa Chau, clarissa.chau@sunnybrook.ca
- Recruiting
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
Trois-Rivières, Quebec, G8Z 3R9
Marie-Eve Caron, 819-697-3333 ext. 63238, marie-eve_caron_chrtr@ssss.gouv.qc.ca
Anne-Marie Taboika McMurray, anne-marie.taboika@ssss.gouv.qc.ca
- Recruiting
BC Cancer - Vancouver Island Centre
Victoria, British Columbia
Sarah Egli, 1(604) 675-4100 ext. 205780, sarah.egli@bccancer.bc.ca
Emily White, emily.white@bccancer.bc.ca
- Not yet recruiting
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia
Emily White, 604-675-4100 ext. 205381, emily.white@bccancer.bc.ca
Tanya Berrang
- Recruiting
Windsor Regional Cancer Centre
Windsor, Ontario, N8W2X3
Donna Clinansmith, 519-253-5253, Donna.Clinansmith@wrh.on.ca
Khalid Hirmiz, MD
Australia12 sites, 12 recruiting
- Recruiting
GenesisCare St Andrew's
Adelaide, South Australia, 5000
Maria Acevedo, (08) 8228 6700, maria.acevedo@genesiscare.com
Isabelle Baldock, isabelle.baldock@genesiscare.com
- Recruiting
GenesisCare Bedford Park
Bedford Park, South Australia, 5042
Maria Acevedo, maria.acevedo@genesiscare.com
Rangnekar Geetanjali, geetanjali.rangnekar@genesiscare.com
- Recruiting
GenesisCare Bundaberg
Bundaberg, Queensland, 4670
Nicole Frisby, (07) 4154 9900, nicole.frisby@genesiscare.com
Kristy Longhurst, kristy.longhurst@genesiscare.com
- Recruiting
GenesisCare Darlinghurst
Darlinghurst, New South Wales, 2010
Katerina Zavitsanou, katerina.zavitsanou@genesiscare.com
Shekhar Yadav, shekhar.yadav@genesiscare.com
- Recruiting
GenesisCare Hurstville
Hurstville, New South Wales, 2220
Peter Graham, +61 2 8568 7600, Peter.Graham@genesiscare.com
Katerina Zavitsanou, +61 2 8037 4112, Katerina.Zavitsanou@genesiscare.com
- Recruiting
GenesisCare Fiona Stanley Hospital
Murdoch, Western Austrailia, 6150
Lara Carey, (08) 9366 1510, lara.carey@genesiscare.com
Wilna Van Der Watt, wilna.vanderwatt@genesiscare.com
- Recruiting
GenesisCare Hollywood
Nedlands, Western Australia, 6009
Lara Carey, (08) 9366 1510, lara.carey@genesiscare.com
Wilna Van der Watt, wilna.vanderwatt@genesiscare.com
- Recruiting
GenesisCare Mater Hospital
North Sydney, New South Wales, 2060
Katerine Zavitsanou, 02 8037 4112, katerina.zavitsanou@genesiscare.com
Shekhar Yadav, shekhar.yadav@genesiscare.com
- Recruiting
GenesisCare Southport
Southport, Queensland, 4215
Kristy Longhurst, 07 5507 3600, kristy.longhurst@genesiscare.com
Nicole Frisby, 07 4154 9900, nicole.frisby@genesiscare.com
- Recruiting
GenesisCare Tugun
Tugun, Queensland, 4224
Kristy Longhurst, (07) 5507 3600, kristy.longhurst@genesiscare.com
Nicole Frisby, 07 5507 3600, nicole.frisby@genesiscare.com
- Recruiting
GenesisCare Hervey Bay
Urraween, Queensland, 4655
Nicole Frisby, nicole.frisby@genesiscare.com
Kristy Longhurst, kristy.longhurst@genesiscare.com
- Recruiting
GenesisCare Wembley
Wembley, Washington, 6014
Lara Carey, 08 9366 1510, lara.carey@genesiscare.com
Wilna Van Der Watt, wilna.vanderwatt@genesiscare.com
About this study
Official title: A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Read the detailed description
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.
- Conditions
- Breast Neoplasm Female, Radiotherapy, Cosmetic Outcome
- Being tested
- Whole Breast Irradiation (WBI), Partial Breast Irradiation (PBI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Breast Irradiation (WBI)Radiation
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Partial Breast Irradiation (PBI)Radiation
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
| Study group | Role | What they receive |
|---|---|---|
| Whole Breast Irradiation (WBI) | Active comparator | 26 Gy in 5 fractions to the whole breast Receives: Radiation: Whole Breast Irradiation (WBI) |
| Partial Breast Irradiation (PBI) | Experimental | 26 Gy in 5 fractions to the tumour bed with a margin of normal tissue Receives: Radiation: Partial Breast Irradiation (PBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence
Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast.
Measured: Annually for 5 years post-randomization
Patient Assessment Cosmesis at 3 years
Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS.
Measured: 3 and 5 years post-randomization
Secondary outcomes (7)
Distant Disease Free Survival (DDSF)
Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain).
Measured: Annually for 5 years post-randomization.
Disease Free Survival (DFS)
Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death.
Measured: Annually for 5 years post-randomization.
Overall Survival
Time from randomization to death of any cause.
Measured: 3 years post-randomizaton.
Radiation Toxicity
Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0.
Measured: 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.
Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
A nurse/Clinical Research Associate (CRA) assessment of cosmesis using the EORTC Breast Cosmetic Rating System. Nurses and CRAs will be training in assessing cosmesis using training slides and guide previously developed for other trials.
Measured: 3 and 5 years post-randomization.
Patient Assessed Cosmesis at 5 years.
Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System13,27,42 and the UK Patient Reported Outcomes Questions following BCS.
Measured: 5 years post-randomization.
Patient Reported Quality of Life
Patients will complete the EORTC Breast Cancer Quality of life questionnaire
Measured: 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start20 Nov 2023
- Primary completionNov 2029 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Timothy Whelan, M.D., Principal investigator, Juravinski Cancer Centre and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417516
- Sponsor's protocol ID
- OCOG-2022-RAPID2
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
- ClinicalTrials.gov ID
- NCT05417516
- Acronym / sponsor ID
- OCOG-2022-RAPID2
- Conditions
- Breast Neoplasm Female, Radiotherapy, Cosmetic Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 14 Jun 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.
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Detailed description
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Breast Irradiation (WBI) | Active comparator | Radiation: Whole Breast Irradiation (WBI)26 Gy in 5 fractions to the whole breast |
| Partial Breast Irradiation (PBI) | Experimental | Radiation: Partial Breast Irradiation (PBI)26 Gy in 5 fractions to the tumour bed with a margin of normal tissue |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
- Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours <= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Key exclusion criteria (13 listed)
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size >3cm in greatest diameter on pathological examination.
- Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
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 Irradiation (WBI)The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable). | Radiation | Whole Breast Irradiation (WBI) |
| Partial Breast Irradiation (PBI)The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable). | Radiation | Partial Breast Irradiation (PBI) |
Primary outcome
Local Recurrence
Time frame: Annually for 5 years post-randomization
Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast.
Patient Assessment Cosmesis at 3 years
Time frame: 3 and 5 years post-randomization
Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS.
7 secondary outcomes
Distant Disease Free Survival (DDSF)
Time frame: Annually for 5 years post-randomization.
Disease Free Survival (DFS)
Time frame: Annually for 5 years post-randomization.
Overall Survival
Time frame: 3 years post-randomizaton.
Radiation Toxicity
Time frame: 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.
Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
Time frame: 3 and 5 years post-randomization.
Patient Assessed Cosmesis at 5 years.
Time frame: 5 years post-randomization.
Patient Reported Quality of Life
Time frame: 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
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 14 Sep 2026.
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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.
Timothy Whelan, M.D. principal investigator
Juravinski Cancer Centre and McMaster University
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole Breast Irradiation (WBI) and Partial Breast Irradiation (PBI) in people with Breast Neoplasm Female and Radiotherapy, run by Ontario Clinical Oncology Group (OCOG) at 31 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Canada, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shelley Chambers, MA (905-527-2299 ext. 42618, schamber@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence (time frame: Annually for 5 years post-randomization). 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?
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 14 Sep 2026.