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Selective Estrogen Receptor Modulator

Limited Endocrine Therapy for Breast Cancer (LALEAST Trial)

Phase 2
Waitlist Available
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prosigna® score in the low risk range, defined as an ROR of 40 or lower
Stage pT1N0, pT2N0, pT1N0i+, or pT2N0i+ with tumor size sufficient for Prosigna® testing, and with negative surgical margins
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after the last patient is enrolled
Awards & highlights

LALEAST Trial Summary

This trial is for women over 50 with hormone receptor positive, HER2 negative, node negative breast cancer. The study is testing whether reducing adjuvant endocrine therapy from 5 to 2 years is safe and does not reduce the expected excellent breast cancer specific outcomes for this population.

Who is the study for?
This trial is for women over 50 with a specific type of low risk, hormone receptor positive, HER2 negative breast cancer that hasn't spread. They must not have started endocrine therapy or had certain cancers in the last 5 years and should be expected to live at least another 5 years.Check my eligibility
What is being tested?
The trial tests if taking Tamoxifen Citrate for just two years instead of five is safe and effective for older women with low risk breast cancer as determined by histopathologic criteria and Prosigna® score.See study design
What are the potential side effects?
Tamoxifen Citrate can cause hot flashes, vaginal symptoms, leg cramps, blood clots, cataracts, changes in mood or libido among other side effects. The severity varies from person to person.

LALEAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has a low Prosigna score, 40 or less.
Select...
My breast cancer is early stage with clear surgical margins and can be tested with Prosigna.
Select...
My breast cancer is hormone receptor positive, HER2 negative, and not spread to both breasts.
Select...
I have not had, nor am I planning to have, chemotherapy before or after surgery for this breast cancer.
Select...
I have never had hormone receptor positive breast cancer or started hormone therapy before joining.
Select...
I have not started hormone therapy.

LALEAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after the last patient is enrolled
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years after the last patient is enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distant Relapse Free Interval at five years
Secondary outcome measures
Ten year breast cancer free interval
Ten year contralateral breast cancer incidence

Side effects data

From 2008 Phase 2 trial • 30 Patients • NCT00005908
87%
Neutrophils/granulocytes (ANC/AGC)
73%
Alopecia
70%
Leukocytes (total WBC)
60%
Fatigue (lathargy, malaise, asthenia)
53%
Hot flashes/flashes
47%
Hyperglycemia
43%
Hand/foot skin reaction
43%
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
40%
Nausea
37%
Hand-foot skin reaction
37%
Infection without neutropenia
33%
Neuro-sensory
33%
Nail changes
33%
Taste disturbance (dysgeusia)
33%
Diarrhea (without colostomy)
30%
Hemoglobin (hgb)
30%
Myalgia (muscle ache)
30%
Pain-Other
30%
Tearing (watery eyes)
27%
Vomiting
27%
Anorexia
27%
Headache
27%
Mood alteration-depression
23%
Arthralgia (joint pain)
23%
Constipation
23%
Mood alteration-anxiety/agitation
23%
Hypoalbuminemia
20%
SGPT (ALT)
17%
Infection, Other
17%
SGOT (AST)
17%
Bilirubin
17%
Sexual/reproductive function-Other
13%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
13%
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
13%
Abdominal pain or cramping
13%
Bone pain
13%
Insomnia
13%
Libido
13%
Lymphatics
13%
Muscle weakness (not due to neuropathy)
10%
Fatigue (lethargy, malaise, asthenia)
10%
Vision-blurred vision
10%
Febrile neutropenia
10%
Chest pain (non-cardiac and non-pleuritic)
10%
Hypomagnesemia
10%
Irregular menses (change from baseline)
10%
Platelets
10%
Rash/desquamation
10%
Pigmentation changes (e.g., vitiligo)
10%
Skin-Other
10%
Memory loss
7%
Dry eye
7%
Allergic reaction/hypersensitivity (including drug fever)
7%
Thrombosis/embolism
7%
Cough
7%
Dehydration
7%
Dysmenorrhea
7%
Dyspepsia/heartburn
7%
Dyspnea (shortness of breath)
7%
Edema
7%
Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)
7%
Flatulence
7%
GI-Other
7%
Hyponatremia
7%
Hypotension
7%
Mouth dryness
7%
Palpitation
7%
Phlebitis (superficial)
7%
Pruritis
7%
Radiation dermatitis
7%
Hematologic-Other
3%
Urticaria (hives, welts, wheals)
3%
Weight loss
3%
Neuropathy-sensory
3%
Injection site reaction
3%
Colitis
3%
Vaginal bleeding
3%
Alkaline phosphatase
3%
Hypophosphatemia
3%
Pleural effusion (non-malignant)
3%
Stomatitis/pharyngitis (oral/pharyngeal/mucositis)
3%
Metabolic-Other
3%
Ocular-Other
3%
Syncope
3%
Urinary frequency/urgency
3%
Allergy-Other
3%
Creatinine
3%
Depressed level of consciousness
3%
Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant)
3%
Dizziness/lightheadedness
3%
Dry skin
3%
Dysphagia, esophagitis, odynophagia (painful swallowing)
3%
Hearing-Other
3%
Hypokalemia
3%
Hypoxia
3%
Lymphatics-Other
3%
Neuropathy motor
3%
Pulmonary-Other
3%
Renal/GU-Other
3%
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
3%
Sweating (diaphoresis)
3%
Hematuria (in absence of vaginal bleeding)
3%
Hyperuricemia
3%
Syndromes-Other
3%
Wound-infectious
3%
Wound-non-infectious
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel/Capecitabine - A & B

LALEAST Trial Design

1Treatment groups
Experimental Treatment
Group I: standard of care endocrine therapy for two yearsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,197 Total Patients Enrolled
18 Trials studying Breast Cancer
7,986 Patients Enrolled for Breast Cancer
NanoString Technologies, Inc.Industry Sponsor
10 Previous Clinical Trials
1,820 Total Patients Enrolled
8 Trials studying Breast Cancer
1,024 Patients Enrolled for Breast Cancer
Canadian Cancer Society (CCS)OTHER
79 Previous Clinical Trials
37,631 Total Patients Enrolled
8 Trials studying Breast Cancer
631 Patients Enrolled for Breast Cancer

Media Library

Tamoxifen Citrate (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03917082 — Phase 2
Breast Cancer Clinical Trial 2023: Tamoxifen Citrate Highlights & Side Effects. Trial Name: NCT03917082 — Phase 2
Tamoxifen Citrate (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03917082 — Phase 2
Breast Cancer Research Study Groups: standard of care endocrine therapy for two years
~84 spots leftby May 2026
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