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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

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.

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My breast cancer is early stage with clear surgical margins and can be tested with Prosigna.

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My breast cancer is hormone receptor positive, HER2 negative, and not spread to both breasts.

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I have not had, nor am I planning to have, chemotherapy before or after surgery for this breast cancer.

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I have never had hormone receptor positive breast cancer or started hormone therapy before joining.

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I have not started hormone therapy.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Distant Relapse Free Interval at five years

Secondary study objectives

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%

Anorexia

27%

Vomiting

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%

Vision-blurred vision

10%

Fatigue (lethargy, malaise, asthenia)

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

Dry eye

Allergic reaction/hypersensitivity (including drug fever)

Thrombosis/embolism

Cough

Dehydration

Dysmenorrhea

Dyspepsia/heartburn

Dyspnea (shortness of breath)

Edema

Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)

Flatulence

GI-Other

Hyponatremia

Hypotension

Mouth dryness

Palpitation

Phlebitis (superficial)

Pruritis

Radiation dermatitis

Hematologic-Other

Colitis

Weight loss

Alkaline phosphatase

Neuropathy-sensory

Vaginal bleeding

Hypophosphatemia

Urticaria (hives, welts, wheals)

Injection site reaction

Pleural effusion (non-malignant)

Stomatitis/pharyngitis (oral/pharyngeal/mucositis)

Metabolic-Other

Ocular-Other

Syncope

Urinary frequency/urgency

Allergy-Other

Creatinine

Depressed level of consciousness

Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant)

Dizziness/lightheadedness

Dry skin

Dysphagia, esophagitis, odynophagia (painful swallowing)

Hearing-Other

Hypokalemia

Hypoxia

Lymphatics-Other

Neuropathy motor

Pulmonary-Other

Renal/GU-Other

Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT

Sweating (diaphoresis)

Hematuria (in absence of vaginal bleeding)

Hyperuricemia

Syndromes-Other

Wound-infectious

Wound-non-infectious

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel/Capecitabine - A & B

Awards & Highlights

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.

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

0 / 6Eligibility criteria met