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Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

NCT03917082 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer Female
  • Hormone Receptor Positive Tumor

Interventions

DRUG

Tamoxifen Citrate

current standard of care is 5 years endocrine therapy after early breast cancer. Intervention will test if 2 years is adequate for population with low recurrence risk based on genomic tissue based test

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • NanoString Technologies, Inc.

    collaborator INDUSTRY

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Caroline Lohrisch, MC · BC Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
51 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2026-05-01
Completion
2029-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917082 on ClinicalTrials.gov