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CDK4/6 Inhibitor
Lasofoxifene and Abemaciclib vs Fulvestrant and Abemaciclib for Breast Cancer (ELAINEIII Trial)
Phase 3
Recruiting
Research Sponsored by Sermonix Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue
Pre- or postmenopausal women or men
Must not have
Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment)
Sexually active premenopausal women and men unwilling to use double-barrier contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will explore a new combination of drugs to treat breast cancer in people who have previously received other treatments.
Who is the study for?
This trial is for pre- or postmenopausal women and men with advanced ER+/HER2- breast cancer that has worsened on certain treatments. They must have specific ESR1 mutations, be able to swallow pills, and have good organ function. Brain metastases are okay if stable and untreated by steroids. People can't join if they've had severe lung disease from treatment, need urgent chemo, progressed on similar drugs before, or have conditions increasing blood clot risks.
What is being tested?
The study compares the effectiveness of lasofoxifene combined with abemaciclib versus fulvestrant combined with abemaciclib in treating breast cancer with an ESR1 mutation. Participants will either take lasofoxifene orally daily plus twice-daily abemaciclib or get monthly fulvestrant injections plus twice-daily abemaciclib.
What are the potential side effects?
Potential side effects include those common to hormone therapies like hot flashes and joint pain, as well as possible liver issues, fatigue, low white blood cell counts (increasing infection risk), diarrhea from abemaciclib; lasofoxifene may also increase the risk of blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific mutation in the ESR1 gene.
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I am a woman or man, regardless of my menopause status.
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I am fully active or have some restrictions but can still care for myself.
Select...
My breast cancer has spread and can be measured or seen on scans.
Select...
I can swallow pills.
Select...
My cancer is ER positive and HER2 negative.
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My ER+ breast cancer has worsened on my first hormone therapy for its advanced stage.
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My advanced breast cancer hasn't worsened in 6 months while on AI/CDKi treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active infection requiring IV antibiotics or antifungals.
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I am sexually active, can still have children, and won't use two forms of birth control.
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I am taking medication that strongly affects liver enzymes.
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My cancer progressed despite treatment with specific hormone therapies.
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I have had severe lung issues due to past treatments.
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My cancer has spread to the lymph vessels in my lungs.
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I need strong chemotherapy for a severe crisis in my organs.
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I do not have any major health issues that could affect my safety in the study.
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I do not have conditions like severe heart failure or long-term immobility that increase my risk for blood clots.
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I have had a blood clot in my lungs or veins, or I have a condition that increases my risk of blood clots.
Select...
I am currently taking strong CYP3A4 inhibitor medications.
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I have been diagnosed with HIV, HBV, or HCV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Clinical benefit rate (CBR)
Duration of response (DoR) in subjects with an objective response
Incidence of Adverse Events (AEs) and Serious AEs
+5 moreSide effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
55%
Fatigue
34%
Hypertension
27%
Mucositis
24%
Nausea
22%
Weight gain
20%
Diarrhea
20%
Arthralgia
19%
Hypothermia
19%
Upper respiratory infection
19%
Weight loss
18%
Vomiting
17%
Headache
15%
Anorexia
15%
Back pain
15%
Constipation
15%
Pruritus
14%
Cough
12%
Dyspepsia
12%
Bone pain
11%
Abdominal pain
11%
Fever
10%
Alopecia
10%
Flu like symptoms
10%
Pain
10%
Hot flashes
8%
Dizziness
8%
Obesity
8%
Pain in extremity
6%
Anemia
6%
Dysgeusia
5%
Palmar-plantar erythrodysesthesia syndrome
5%
Nail disorder
2%
Respiratory infection
1%
Urinary bladder carcinoma
1%
Urinary tract infection
1%
Stroke
1%
Acidosis
1%
Suicide attempt
1%
Bone fracture
1%
Catheter related infection
1%
Dyspnea
1%
Febrile neutropenia
1%
Heart failure
1%
Hematoma
1%
Lymphedema
1%
Pneumonitis
1%
Hip replacement
1%
Tooth infection
1%
Uveitis
1%
Respiratory failure
1%
Non-cardiac chest pain
1%
Sepsis
1%
Hypercalcemia
1%
Bacteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Palbociclib Plus Exemestane
Cohort 1 and 2: Capecitabine
Cohort 2: Palbociclib Plus Fulvestrant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Group II: Reference TherapyActive Control1 Intervention
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Find a Location
Who is running the clinical trial?
Sermonix Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection requiring IV antibiotics or antifungals.I am sexually active, can still have children, and won't use two forms of birth control.My brain metastases are stable, treated, not needing steroids, and I've had no symptoms for over 3 months.I am taking medication that strongly affects liver enzymes.My cancer has a specific mutation in the ESR1 gene.I am a woman or man, regardless of my menopause status.I am fully active or have some restrictions but can still care for myself.My breast cancer has spread and can be measured or seen on scans.I can swallow pills.My cancer progressed despite treatment with specific hormone therapies.You have a history of a heart condition that affects the time it takes for your heart to recharge between beats, or your QTc is longer than 480 milliseconds.I haven't had major radiotherapy in the last 30 days, except for pain relief or to treat bones at risk of breaking.I have had severe lung issues due to past treatments.My cancer has spread to the lymph vessels in my lungs.I need strong chemotherapy for a severe crisis in my organs.My cancer is resistant to certain treatments due to RB1 mutation.I do not have any major health issues that could affect my safety in the study.I haven't had any cancer except for skin cancer or breast cancer in the last 5 years.If you are a woman who could still have children, you are pregnant.You have a history of not following your doctor's treatment plans.I do not have conditions like severe heart failure or long-term immobility that increase my risk for blood clots.My organs are working well.I have had a blood clot in my lungs or veins, or I have a condition that increases my risk of blood clots.My cancer is ER positive and HER2 negative.You are allergic to fulvestrant or any of its ingredients.I am currently taking strong CYP3A4 inhibitor medications.I have been diagnosed with HIV, HBV, or HCV.My ER+ breast cancer has worsened on my first hormone therapy for its advanced stage.My advanced breast cancer hasn't worsened in 6 months while on AI/CDKi treatment.I've had one chemotherapy for my advanced cancer and recovered from its major side effects.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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