Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer (LALEAST)

June 13, 2023 updated by: Caroline Lohrisch, British Columbia Cancer Agency

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Women older than 50 at diagnosis of an invasive breast cancer which is all of: node negative/N0i+; T1 or T2; low or intermediate grade; with strong or intermediate expression of hormone receptors (ER and PR); and HER2 negative, and who have had adequate local therapy for their tumor, are invited to participate in Prosigna® screening. A sample of their excised tumor is sent for Prosigna® testing. This is a validated and widely approved genomic test to assess recurrence risk in hormone receptor positive/HER2 negative, node negative breast tumors. Tumors with a low risk result, defined as Risk of Recurrence (ROR) less than or equal to 40, are then eligible for enrollment on the LA LEAST study of 2 years of endocrine therapy (tamoxifen for pre/perimenopausal women and aromatase inhibitor for postmenopausal women). To mimic real life, there is flexibility to switch to an alternate standard of care endocrine therapy during the two years if intolerable side effects develop. During the two years of therapy, participants are seen every six months and complete periodic quality of life (QOL) questionnaires designed to measure quality of life, mood, side effects, and anxiety/fear of recurrence. Following two years of therapy, participants have annual study visits until year 10, with similar questionnaires at some but not all time points, and assessment of study endpoints. Primary endpoint is the 5 year distant relapse free interval (DRFI), defined as freedom from distant recurrence or breast cancer death at five years. Secondary endpoints include longitudinal QOL comparisons, 10 year breast cancer free interval and 10 year contralateral breast cancer rate. It is anticipated that about 400 individuals will need to be screened to enroll 290 participants with requisite low score. The sample size is based on an expected 5 year DRFI of 96.8%, one sided alpha of 0.05 and a rejection of the alternate hypothesis if the lower boundary of the one sided confidence interval yields an observed DRFI below 95%.

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • BC Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • aromatase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after the last patient is enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years after the last patient is enrolled
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.
ten years after the last patient is enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

Canadian Cancer Society (CCS)
NanoString Technologies, Inc.

Investigators

  • Study Chair: Caroline Lohrisch, MC, BC Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2019

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LA LEAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

summary results for participants will be shared in peer review meetings and publications

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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