NCT01961531 is a NA clinical trial of Accuboost APBI in Breast Cancer, sponsored by Brown University.

Who is sponsoring NCT01961531?

NCT01961531 is sponsored by Brown University.

What drugs are being tested in NCT01961531?

Interventions in NCT01961531: Accuboost APBI.

What condition does NCT01961531 study?

NCT01961531 studies Breast Cancer.

Is NCT01961531 still recruiting?

NCT01961531 is currently completed. Last updated 4 March 2022.

Are results published for NCT01961531?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-04 · How we verify

NCT01961531

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

Completed NA Results posted Last updated 4 March 2022

What this trial tests

NA trial testing Accuboost APBI in Breast Cancer in 40 participants. Completed in 30 November 2021.

Timeline

24 July 2014

Primary endpoint
26 October 2016

30 November 2021

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	24 July 2014
Primary completion	26 October 2016
Estimated completion	30 November 2021
Sites	3 locations across United States

Drugs / interventions tested

Accuboost APBI

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Brown University

Who can join

50 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Any Toxicity Related to the Radiation Treatment Primary · during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Group	Value	95% CI
Accuboost APBI	40

Number of Participants With Ipsilateral Breast Local Recurrence Secondary · annually for 2 years post treatment

Group	Value	95% CI
Accuboost APBI	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected from signing of ICF until 5 years post treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Accuboost APBI

Serious: 0/40 (0%)

Deaths: —

Other adverse events (19 terms — click to expand)

Reaction	System	Accuboost APBI
Acute Skin Reaction	Skin and subcutaneous tissue disorders	—
Discomfort	General disorders	—
Fatigue	General disorders	—
Telangiectasia	Skin and subcutaneous tissue disorders	—
Breast Volume/Hypoplasia	Reproductive system and breast disorders	—
Skin Induration/Fibrosis	Skin and subcutaneous tissue disorders	—
Hyperpigmentation	Skin and subcutaneous tissue disorders	—
Breast Pain	Reproductive system and breast disorders	—
Fibrosis-cosmesis	Musculoskeletal and connective tissue disorders	—
Skin Atrophy	Skin and subcutaneous tissue disorders	—
Seroma	Musculoskeletal and connective tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Breast Soreness	Reproductive system and breast disorders	—
Edema	General disorders	—
Shoulder Pain	General disorders	—
Contralateral Breast Infection	Infections and infestations	—
Breast Tenderness	Reproductive system and breast disorders	—
Hypopigmentation	Skin and subcutaneous tissue disorders	—
Folliculitis	Infections and infestations	—

Data from ClinicalTrials.gov NCT01961531 adverse events section.

Sponsor's own description

To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Brown University trials

Trials by the same sponsor.

NCT07502872 — TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-g · Phase 2 · not yet recruiting
NCT07118618 — Probenecid Administration for Alcohol Craving and Consumption · Phase 2 · recruiting
NCT07398443 — Using Novel Behavioral Economic Measures to Characterize Dual Marijuana and Tobacco Use in Young Adults · NA · recruiting
NCT05901766 — Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment · Phase 4 · not yet recruiting
NCT06974604 — Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01961531 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brown University
Last refreshed: 4 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01961531.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing