Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer (LALEAST)
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ClinicalTrials.gov Identifier: NCT03917082 |
Recruitment Status :
Recruiting
First Posted : April 16, 2019
Last Update Posted : December 9, 2020
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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 |
Allocation: | N/A |
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) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 23, 2019 |
Estimated Primary Completion Date : | May 1, 2026 |
Estimated Study Completion Date : | May 1, 2029 |

Arm | Intervention/treatment |
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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.
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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.

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Ages Eligible for Study: | 51 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | breast cancer incidence ratio in women vs men is 10:1. Given the sample size of the study, it is unlikely that enrolling men will provide any meaningful data about the impact of limited endocrine therapy for male breast cancer. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: for Prosigna® screening
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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

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 2707 | clohrisch@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer | Recruiting |
Vancouver, British Columbia, Canada, V5Z4E6 | |
Contact: Caroline Lohrisch, MD 6048776000 clohrisch@bccancer.bc.ca | |
Sub-Investigator: Tamara Shenkier, MD | |
Sub-Investigator: Stephen Chia, MD | |
Sub-Investigator: Nathalie Levasseur, MD | |
Sub-Investigator: Diego Villa, MD | |
Sub-Investigator: Karen Gelmon, MD | |
Sub-Investigator: Sophie Sun, MD | |
Principal Investigator: Caroline Lohrisch, MD | |
Sub-Investigator: Daniel Khalaf, MD | |
Sub-Investigator: Christine Simmons, MD | |
Sub-Investigator: Gary Pansegrau, MD |
Study Chair: | Caroline Lohrisch, MC | BC Cancer |
Responsible Party: | Caroline Lohrisch, Medical Oncologist, Department head, medical oncology Vancouver Centre, British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT03917082 |
Other Study ID Numbers: |
LA LEAST |
First Posted: | April 16, 2019 Key Record Dates |
Last Update Posted: | December 9, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | summary results for participants will be shared in peer review meetings and publications |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
endocrine therapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Aromatase Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Steroid Synthesis Inhibitors Enzyme Inhibitors |