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NCT03917082: LALEAST

Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

Active, enrolled Phase 2 Last updated 15 June 2023
What this trial tests

Phase 2 trial testing Tamoxifen Citrate in Breast Cancer Female in 290 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
23 September 2019
Primary endpoint
1 May 2026
1 May 2029

Quick facts

Lead sponsorBritish Columbia Cancer Agency
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment290
Start date23 September 2019
Primary completion1 May 2026
Estimated completion1 May 2029
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

British Columbia Cancer Agency

Who can join

51 and older, female only, with Breast Cancer Female or Hormone Receptor Positive Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis. The study hypothesis is that reducing adjuvant endocrine therapy from 5 to 2 years in a population with low risk of breast cancer; as determined by histopathologic criteria and confirmed by low risk genomic analysis using Prosigna®; will be safe and acceptable to this population, and will not compromise the expected excellent breast cancer specific outcomes for this population.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer-a prospective national multicentre study (EMIT-1).
    Ohnstad HO, Blix ES, Akslen LA, Gilje B, et al · · 2024 · cited 10× · PMID 38838499 · DOI 10.1016/j.esmoop.2024.103475
  2. Gene Expression Assays to Tailor Adjuvant Endocrine Therapy for HR+/HER2- Breast Cancer.
    Bottosso M, Miglietta F, Vernaci GM, Giarratano T, et al · · 2024 · cited 8× · PMID 38656833 · DOI 10.1158/1078-0432.ccr-23-4020
  3. Management Strategies for Older Patients with Low-Risk Early-Stage Breast Cancer: A Physician Survey.
    Alzahrani M, Clemons M, Chang L, Vendermeer L, et al · · 2021 · cited 4× · PMID 35049675 · DOI 10.3390/curroncol29010001

Verify or expand the search:

Other trials of Tamoxifen Citrate

Trials testing the same drug.

Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

Other British Columbia Cancer Agency trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03917082.

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