← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after last accrual
Awards & highlights

e3 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.Check my eligibility
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.See study design
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.

e3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have more than one cancer spot in my breast, each far apart.
Select...
I have more than one cancer spot close to the biggest tumor in the same area of my breast.
Select...
I do not have severe heart disease or recent heart attacks.
Select...
I have had a procedure to check for cancer in my underarm lymph nodes.
Select...
My diabetes is under control.
Select...
I do not have any uncontrolled lung diseases.
Select...
I can take pills by mouth.
Select...
I am not taking and do not plan to take trastuzumab.
Select...
My stomach and intestines work well and I don’t have diseases that affect how I absorb medicine.
Select...
I will not take any other cancer drugs during this study.
Select...
I have completed surgery for breast cancer with clear margins and checked lymph nodes.
Select...
My cancer is ER or PR positive as per ASCO/CAP guidelines.
Select...
I have finished the standard initial treatment for my cancer.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I do not have severe heart disease.
Select...
My cancer is HER2 negative according to specific testing guidelines.
Select...
My breast cancer is ER and/or PR positive and HER2 negative, and I plan to undergo hormone therapy.

e3 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-Free Survival (IDFS)
Secondary outcome measures
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%
Weight decreased
16%
Fatigue
16%
Blood cholesterol increased
15%
Gamma-glutamyltransferase increased
15%
Diarrhoea
13%
Pneumonitis
12%
Upper respiratory tract infection
12%
Headache
12%
Nausea
12%
Hypertriglyceridaemia
11%
Back pain
11%
Pruritus
9%
Myalgia
9%
Insomnia
9%
Blood lactate dehydrogenase increased
8%
Arthralgia
8%
Dyspnoea
8%
Productive cough
8%
Dyspepsia
8%
Oedema peripheral
7%
Dysgeusia
7%
Pain in extremity
6%
Constipation
6%
Pyrexia
6%
Hypertension
5%
Hypercholesterolaemia
5%
Aphthous ulcer
5%
Dyslipidaemia
5%
Neutrophil count decreased
5%
Asthenia
5%
Pneumonia
5%
Urinary tract infection
5%
Lymphoedema
5%
Epistaxis
5%
Thrombocytopenia
5%
Blood alkaline phosphatase increased
5%
Dry skin
4%
Abdominal pain
4%
Hypokalaemia
4%
Hypophosphataemia
4%
Mouth ulceration
4%
Toothache
4%
Peripheral swelling
4%
Rhinorrhoea
4%
Acne
4%
Urticaria
4%
Blood creatinine increased
3%
Cellulitis
3%
Abdominal discomfort
3%
White blood cell count decreased
3%
Face oedema
3%
Vomiting
3%
Nail disorder
3%
Abdominal pain upper
3%
Diabetes mellitus
3%
Depression
3%
Non-cardiac chest pain
3%
Influenza
3%
Nasopharyngitis
3%
Pharyngitis
3%
Haemoglobin decreased
3%
Oropharyngeal pain
3%
Hyperkalaemia
3%
Hyperlipidaemia
3%
Paraesthesia
3%
Alopecia
3%
Dermatitis acneiform
2%
Influenza like illness
2%
Mucosal inflammation
2%
Flank pain
2%
Neck pain
2%
Musculoskeletal pain
2%
Platelet count decreased
2%
Eczema
2%
Hypoaesthesia
2%
Onychomadesis
2%
Dizziness
2%
Rash maculo-papular
2%
Haemorrhoids
2%
Pain
2%
Vitamin D deficiency
2%
Pleural effusion
2%
Blood triglycerides increased
1%
Gastric ulcer
1%
Abdominal distension
1%
Ascites
1%
Urosepsis
1%
Cardiopulmonary failure
1%
Vision blurred
1%
Gait inability
1%
Haematochezia
1%
Bone pain
1%
Cartilage injury
1%
Femur fracture
1%
Ligament sprain
1%
Eastern cooperative oncology group performance status worsened
1%
Interstitial lung disease
1%
Liver function test increased
1%
Urethritis
1%
Ingrowing nail
1%
Eye pain
1%
Joint stiffness
1%
Tachycardia
1%
Atypical pneumonia
1%
Herpes virus infection
1%
Gastroenteritis
1%
Spinal pain
1%
Muscular weakness
1%
Onycholysis
1%
Asthma
1%
Contrast media allergy
1%
Dehydration
1%
Viral infection
1%
Soft tissue infection
1%
Cardiac failure
1%
Large intestinal haemorrhage
1%
Hyponatraemia
1%
Dental caries
1%
Hypomagnesaemia
1%
Pain in jaw
1%
Cardiac arrest
1%
Left ventricular failure
1%
Ventricular tachycardia
1%
Abdominal hernia
1%
Diabetes mellitus inadequate control
1%
Joint effusion
1%
Metastases to lung
1%
Folliculitis
1%
Furuncle
1%
Gingivitis
1%
Lower respiratory tract infection
1%
Oral herpes
1%
Sinusitis
1%
Hypocalcaemia
1%
Breast pain
1%
Dyspnoea exertional
1%
Haemoptysis
1%
Wheezing
1%
Palmar-plantar erythrodysaesthesia syndrome
1%
Hot flush
1%
Atrial fibrillation
1%
Dysphagia
1%
Gastric haemorrhage
1%
Tumour necrosis
1%
Gastrooesophageal reflux disease
1%
Oral pain
1%
Musculoskeletal chest pain
1%
Rash papular
1%
Rash pruritic
1%
Respiratory failure
1%
Skin ulcer
1%
Pulmonary embolism
1%
Pulmonary oedema
1%
Overdose
1%
Leukopenia
1%
Neutropenia
1%
Tumour pain
1%
Central nervous system haemorrhage
1%
Hydrocephalus
1%
Intracranial aneurysm
1%
Lethargy
1%
Acute kidney injury
1%
Renal failure
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Asian
Non-Asian

e3 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
anastrozole
2005
Completed Phase 3
~18970
everolimus
2005
Completed Phase 3
~1550
exemestane
2005
Completed Phase 4
~27080
goserelin acetate
2010
Completed Phase 3
~10130
letrozole
1998
Completed Phase 3
~16660
leuprolide acetate
2005
Completed Phase 4
~6650
tamoxifen citrate
2000
Completed Phase 3
~17870

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,872 Total Patients Enrolled
53 Trials studying Breast Cancer
63,387 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
263,231 Total Patients Enrolled
53 Trials studying Breast Cancer
63,387 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,214 Total Patients Enrolled
939 Trials studying Breast Cancer
1,541,421 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01674140 — Phase 3
Breast Cancer Research Study Groups: Arm I, Arm II
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT01674140 — Phase 3
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01674140 — Phase 3
Breast Cancer Patient Testimony for trial: Trial Name: NCT01674140 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is everolimus most often prescribed?

"Stage t2b carcinoma of the prostate is most commonly treated with everolimus. everolimus is also effective at treating other conditions like lung cancer, advanced carcinoid tumor, and high risk."

Answered by AI

How many people have been accepted into the research project?

"Unfortunately, this trial is no longer looking for patients. The listing was created on April 1st, 2013 and last updated on July 12th, 2022. However, there are presently 2683 clinical trials actively enrolling participants with breast cancer and 399 trials for everolimus actively enrolling participants."

Answered by AI

In how many different geographical locations is this research study being conducted?

"Currently, this study is situated in Kings County Hospital in Brooklyn, New york, Saint Elizabeth Youngstown Hospital in Youngstown, Ohio, and The Community Hospital in Munster, Indiana. 100 other locations are also included."

Answered by AI

What is the success rate of everolimus in previous medical trials?

"Brooklyn, New york is currently conducting many of the 399 active clinical trials for everolimus, a medication that was first studied in 1994 at Queen Mary University of London. A total of 3661 trials have been completed to date."

Answered by AI

Has everolimus undergone the necessary drug approval process in the United States?

"There is both preclinical and clinical data that suggests everolimus is safe for human use, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
New York
Illinois
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Baylor Medical Center at Irving
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Had lumpectomy on 1/27/2022. Had 33 radiation sessions. Cannot tolerate A.I.s.
PatientReceived 1 prior treatment
I. had a lumpectomy on 1/27/2021. Small tumor (11 mm), no lymph node involvement, good margins. I had 33 radiation sessions, ending on 7/18/2023. I took Anastrozole from February through July, but had terrible side effects and it contributed to my left knee blowing out and putting me in a wheelchair for parts of September, October and November, so I have not taken any A.I. pills since Aug. 7. My tumor was 95% estrogen positive, so I am seeking to lose weight for both this ailment, my knee and my Type 2 well-controlled diabetes. I am in Austin for half the year (78652) and also have homes in Illinois (60605; 61244) where I will be beginning in May this year. I am 5'2 and weigh 204 lbs. and Ozempic has not contributed to significant weight loss, partially because of my knee situation and its limitations, which presented as a meniscus tear and has improved after 6 full months (I had shots in my knee in Oakbrook, Illinois, on Sept. 21, 2023.).
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is the drug designed to prevent ipsalateral or contra lateral recurrence?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
2013. "S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01674140.
All > Acth > Afinitor
~167 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top