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Clinical Trials in Canada / NCT03917082
Active, not recruiting Phase 2

Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

NCT03917082 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2019-09-23
Last updated
2023-06-15

Condition(s) studied

Breast Cancer FemaleHormone Receptor Positive Tumor

Investigational drug(s) / intervention(s)

Tamoxifen Citrate →

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

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.

Eligibility

Sex
FEMALE
Min age
51 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: for Prosigna® screening * Diagnosis of invasive breast cancer which is: * Unifocal or multifocal (not multicentric) * Unilateral * Moderate or strongly hormone receptor positive * HER2 negative * Ductal grade 1 or 2, or lobular any grade, or pure tubular (any grade) or pure papillary (any grade). If mixed lobular-ductal histology, the ductal component must be grade 1 or 2. * Stage pT1N0 (tumor \</= 20mm, negative node) or pT2N0 (tumor 21-50mm, node negative) or pT1N0i+ (tumor \</=20mm and isolated tumor cells in node\[s\]) or pT2N0i+ (tumor 21-50mm and isolated tumor cells in node\[s\]) (see Appendix 2). Tumor size must be sufficient for Prosigna® testing. pNX (nodal status unknown) stage is not eligible. * Subject must be female * Subject must be age \> 50 years at breast cancer diagnosis * Subject may be pre, peri, or postmenopausal. * Subject must have a \> 5-year life expectancy based on physician judgement of subject's co-morbid illnesses and age * Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice). Surgery will have been no more than 24 weeks prior to endocrine therapy start. Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation. Subjects may undergo Prosigna® screening prior to completion of radiation. * The breast surgery will have achieved negative surgical margins. Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy) * No (neoadjuvant or adjuvant) chemotherapy given or planned for this breast cancer * No other non-breast cancer within the last 5 years, except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ * No prior hormone receptor positive invasive breast cancer. Prior contralateral DCIS treated with standard of care local therapy, and prior lobular carcinoma in situ (LCIS) are allowed, provided no endocrine therapy with any of tamoxifen, ovarian suppression, raloxifene, or aromatase inhibitor was given * Subject will have not have started endocrine therapy prior to enrollment * Subject has signed a screening informed consent form * Subject has intent to be adherent to endocrine therapy for two years in the absence of serious toxicity Inclusion criteria for study enrollment: * Prosigna® score in the low risk range, defined as an ROR of 40 or lower * Subject has not yet initiated endocrine therapy * Subject has signed study informed consent form Exclusion Criteria: • Does not meet every inclusion criteria listed above

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BC Cancer Vancouver British Columbia

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03917082 on ClinicalTrials.gov ↗ ← All trials in Canada