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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years after the last patient is enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after the last patient is enrolled
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 • NCT0000590887%
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%
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
13%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
13%
Abdominal pain or cramping
13%
Bone pain
13%
Insomnia
13%
Libido
13%
Lymphatics
13%
Muscle weakness (not due to neuropathy)
10%
Febrile neutropenia
10%
Vision-blurred vision
10%
Fatigue (lethargy, malaise, asthenia)
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%
Allergic reaction/hypersensitivity (including drug fever)
7%
Dry eye
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%
Weight loss
3%
Urticaria (hives, welts, wheals)
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?
NanoString Technologies, Inc.Industry Sponsor
10 Previous Clinical Trials
1,821 Total Patients Enrolled
8 Trials studying Breast Cancer
1,024 Patients Enrolled for Breast Cancer
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,221 Total Patients Enrolled
18 Trials studying Breast Cancer
7,986 Patients Enrolled for Breast Cancer
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,455 Total Patients Enrolled
8 Trials studying Breast Cancer
631 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman over 50, diagnosed with breast cancer at any menopausal stage.My breast cancer has a low Prosigna score, 40 or less.My doctor believes I could live more than 5 years despite my other health issues.My breast cancer is early stage with clear surgical margins and can be tested with Prosigna.My breast cancer is hormone receptor positive, HER2 negative, and not spread to both breasts.I have not had, nor am I planning to have, chemotherapy before or after surgery for this breast cancer.I have agreed to follow a hormone therapy plan for two years unless I experience severe side effects.I have never had hormone receptor positive breast cancer or started hormone therapy before joining.I have not started hormone therapy.I haven't had any cancer other than breast cancer in the last 5 years.
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care endocrine therapy for two years
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical ailment is Tamoxifen Citrate most effective in treating?
"Tamoxifen Citrate is most often given to patients with cancer, but it can also help those with ovulation induction therapy and high risk."
Answered by AI
Is there still room for patients who want to enroll in this clinical trial?
"The latest information on clinicaltrials.gov shows that this study is looking for volunteers. The listing was created on September 23rd, 2019 and updated December 7th, 2020."
Answered by AI
Are there any reports of serious adverse effects from Tamoxifen Citrate?
"Tamoxifen Citrate has received a score of 2 for safety. This is due to the fact that it is still in Phase 2 clinical trials, meaning that while there is some data supporting safety, none yet supports efficacy."
Answered by AI
How many individuals are being research subjects in this investigation?
"Yes, this is an active recruitment according to the information available on clinicaltrials.gov. The posting date was September 23rd 2019 and the most recent update was December 7th 2020. They are looking for a total of 290 patients from 1 location."
Answered by AI
Could you list any other scientific research that has used Tamoxifen Citrate?
"As of now, there are 70 ongoing clinical trials for Tamoxifen Citrate with 23 in Phase 3. Although many of the trails related to this medication are based in Moline, Illinois, there are a total of 7467 locations running these sorts of studies."
Answered by AI
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