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Hormone Therapy

Hormone Therapy +/− Everolimus for Breast Cancer (e3 Trial)

Phase 3

Waitlist Available

Led By Mariana Chavez-MacGregor, MD, MSc

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants

Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant

Must not have

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug

Patients with known hepatitis are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years after last accrual

Awards & highlights

Pivotal Trial

Summary

This trial is studying hormone therapy with or without everolimus to see how well it works in treating patients with breast cancer.

Who is the study for?

This trial is for high-risk breast cancer patients who've had surgery with negative margins and appropriate axillary staging. They must have ER or PR positive status, not be on trastuzumab, have controlled diabetes if applicable, no uncontrolled lung disease, able to take oral meds, not pregnant/nursing, completed standard chemo prior to randomization, performance status 0-2 by Zubrod criteria. No recent heart attacks or severe cardiac disease.

What is being tested?

The study tests hormone therapy's effectiveness against breast cancer when given alone versus alongside everolimus. Hormone therapies include tamoxifen citrate and others that lower estrogen levels in the body. Everolimus may inhibit tumor growth by blocking enzymes needed for cell growth.

What are the potential side effects?

Everolimus can cause mouth sores, infections due to a weakened immune system, lung problems like coughing and shortness of breath; skin issues such as rash or acne; fatigue; diarrhea; nausea; loss of appetite; blood test changes indicating liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have more than one cancer spot in my breast, each far apart.

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I have more than one cancer spot close to the biggest tumor in the same area of my breast.

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I do not have severe heart disease or recent heart attacks.

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I have had a procedure to check for cancer in my underarm lymph nodes.

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My diabetes is under control.

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I do not have any uncontrolled lung diseases.

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I can take pills by mouth.

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I am not taking and do not plan to take trastuzumab.

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My stomach and intestines work well and I don’t have diseases that affect how I absorb medicine.

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I will not take any other cancer drugs during this study.

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I have completed surgery for breast cancer with clear margins and checked lymph nodes.

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My cancer is ER or PR positive as per ASCO/CAP guidelines.

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I have finished the standard initial treatment for my cancer.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I do not have severe heart disease.

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My cancer is HER2 negative according to specific testing guidelines.

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My breast cancer is ER and/or PR positive and HER2 negative, and I plan to undergo hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My stomach and intestines work well and can absorb medication properly.

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I do not have hepatitis.

Select...

My cancer is not HER2 equivocal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years after last accrual

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years after last accrual

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years after last accrual for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Invasive Disease-Free Survival (IDFS)

Secondary study objectives

Distant Recurrence-Free Survival (DRFS)

Overall Survival (OS)

Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.

Side effects data

From 2019 Phase 3 trial • 235 Patients • NCT03176238

63%

Stomatitis

27%

Decreased appetite

26%

Hyperglycaemia

25%

Aspartate aminotransferase increased

24%

Rash

23%

Alanine aminotransferase increased

22%

Cough

19%

Anaemia

16%

Fatigue

16%

Blood cholesterol increased

16%

Weight decreased

15%

Diarrhoea

15%

Gamma-glutamyltransferase increased

13%

Pneumonitis

12%

Hypertriglyceridaemia

12%

Headache

12%

Upper respiratory tract infection

12%

Nausea

11%

Back pain

11%

Pruritus

Myalgia

Blood lactate dehydrogenase increased

Insomnia

Productive cough

Dyspnoea

Dyspepsia

Oedema peripheral

Arthralgia

Dysgeusia

Pain in extremity

Constipation

Pyrexia

Hypertension

Epistaxis

Aphthous ulcer

Hypercholesterolaemia

Lymphoedema

Dyslipidaemia

Urinary tract infection

Asthenia

Pneumonia

Blood alkaline phosphatase increased

Neutrophil count decreased

Dry skin

Thrombocytopenia

Acne

Rhinorrhoea

Abdominal pain

Peripheral swelling

Blood creatinine increased

Hypokalaemia

Hypophosphataemia

Urticaria

Mouth ulceration

Toothache

Abdominal discomfort

Paraesthesia

Cellulitis

Alopecia

Abdominal pain upper

Nail disorder

Diabetes mellitus

Depression

Hyperlipidaemia

Oropharyngeal pain

Influenza

Hyperkalaemia

Face oedema

Non-cardiac chest pain

Nasopharyngitis

Pharyngitis

Haemoglobin decreased

White blood cell count decreased

Dermatitis acneiform

Vomiting

Musculoskeletal pain

Onychomadesis

Pleural effusion

Dizziness

Hypoaesthesia

Influenza like illness

Mucosal inflammation

Pain

Blood triglycerides increased

Platelet count decreased

Vitamin D deficiency

Flank pain

Neck pain

Eczema

Rash maculo-papular

Haemorrhoids

Cardiopulmonary failure

Soft tissue infection

Left ventricular failure

Hyponatraemia

Joint effusion

Hydrocephalus

Dental caries

Haemoptysis

Onycholysis

Pulmonary oedema

Gastric haemorrhage

Central nervous system haemorrhage

Dysphagia

Herpes virus infection

Gastroenteritis

Abdominal hernia

Ascites

Furuncle

Skin ulcer

Lethargy

Interstitial lung disease

Atypical pneumonia

Tumour pain

Respiratory failure

Ventricular tachycardia

Acute kidney injury

Metastases to lung

Lower respiratory tract infection

Dyspnoea exertional

Wheezing

Leukopenia

Gait inability

Renal failure

Abdominal distension

Musculoskeletal chest pain

Pulmonary embolism

Asthma

Palmar-plantar erythrodysaesthesia syndrome

Vision blurred

Folliculitis

Cardiac failure

Contrast media allergy

Dry eye

Gingivitis

Muscular weakness

Eye pain

Intracranial aneurysm

Oral herpes

Sinusitis

Hypocalcaemia

Hypomagnesaemia

Bone pain

Joint stiffness

Pain in jaw

Spinal pain

Breast pain

Ingrowing nail

Rash papular

Rash pruritic

Hot flush

Atrial fibrillation

Cardiac arrest

Gastric ulcer

Haematochezia

Large intestinal haemorrhage

Urethritis

Urosepsis

Viral infection

Cartilage injury

Femur fracture

Ligament sprain

Overdose

Eastern cooperative oncology group performance status worsened

Liver function test increased

Dehydration

Diabetes mellitus inadequate control

Tumour necrosis

Neutropenia

Tachycardia

Gastrooesophageal reflux disease

Oral pain

100%

80%

60%

40%

20%

Study treatment Arm

Asian

Non-Asian

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IIExperimental Treatment7 Interventions

Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.

Group II: Arm IPlacebo Group7 Interventions

Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or an aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo PO daily for 1 year in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

letrozole

1998

Completed Phase 3

~16660

leuprolide acetate

2005

Completed Phase 4

~6650