Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer (LALEAST)
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|ClinicalTrials.gov Identifier: NCT03917082|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : May 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female Hormone Receptor Positive Tumor||Drug: Tamoxifen Citrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm phase II study exploring reducing the duration of endocrine therapy from five to two years in low risk population with early breast cancer|
|Masking:||None (Open Label)|
|Official Title:||LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2026|
|Estimated Study Completion Date :||May 1, 2029|
Experimental: standard of care endocrine therapy for two years
Standard of care adjuvant endocrine therapy for two years. for postmenopausal women, initial therapy will be aromatase inhibitor unless contraindicated, in which case tamoxifen may be used. For premenopausal and perimenopausal women, initial therapy will be tamoxifen unless contraindicated, in which case an lutenizing hormone releasing hormone (LHRH) agonist with / without aromatase inhibitor may be used.
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
Other Name: aromatase inhibitor
- Distant Relapse Free Interval at five years [ Time Frame: 5 years after the last patient is enrolled ]freedom from distant recurrence or breast cancer death at 5 years
- Ten year breast cancer free interval [ Time Frame: ten years after the last patient is enrolled ]freedom from local, regional, distant breast cancer recurrence or death from breast cancer or ipsilateral or contralateral ductal carcinoma in situ or contralateral invasive breast cancer at ten years
- Ten year contralateral breast cancer incidence [ Time Frame: ten years after the last patient is enrolled ]breast cancer occurring in the contralateral breast, including ductal carcinoma in situ (DCIS) and invasive breast cancer, within ten years of enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917082
|Contact: Caroline Lohrisch, MD||6048776000 ext email@example.com|
|Study Chair:||Caroline Lohrisch, MC||BC Cancer|