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Selective Estrogen Receptor Downregulator
Lasofoxifene vs Fulvestrant for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Sermonix Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial evaluates the activity of a drug (lasofoxifene) to treat pre- and postmenopausal women with advanced breast cancer caused by an ESR1 mutation. It will measure progression free survival, clinical benefit, response rate, overall survival, QoL and safety.
Who is the study for?
This trial is for pre- and postmenopausal women with advanced or metastatic ER+/HER2- breast cancer that worsened on an aromatase inhibitor plus a CDK 4/6 inhibitor. Participants must have specific ESR1 mutations, no more than one prior chemo regimen for metastatic disease, good performance status, and adequate organ function. Women with brain metastasis, recent thrombosis or certain heart conditions are excluded.
What is being tested?
The study compares the effectiveness of lasofoxifene versus fulvestrant in improving progression-free survival among participants. It's open-label and randomized, meaning both patients and researchers know which treatment is given and patients are assigned to groups by chance.
What are the potential side effects?
Potential side effects include hot flashes, joint pain, nausea, fatigue, increased risk of blood clots (like deep vein thrombosis), vaginal bleeding or discharge due to hormonal changes caused by the treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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)
Incidence of Adverse Events (AEs) and Serious AEs
Objective Response Rate (ORR)
+1 moreSide effects data
From 2016 Phase 2 & 3 trial • 12 Patients • NCT0211680350%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
CONTUSION
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
HYPERTRIGLYCERIDAEMIA
10%
ARTHRALGIA
10%
HERPES ZOSTER
10%
PNEUMONIA
10%
DRY MOUTH
10%
DYSPEPSIA
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
NAUSEA
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
PLATELET COUNT DECREASED
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LasofoxifeneExperimental Treatment1 Intervention
5 mg/d of oral lasofoxifene
Group II: FulvestrantActive Control1 Intervention
500 mg fulvestrant intramuscular (IM)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lasofoxifene
FDA approved
Find a Location
Who is running the clinical trial?
Sermonix Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
429 Total Patients Enrolled
Linical Accelovance GroupUNKNOWN
Paul V. Plourde, MDStudy DirectorSermonix Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken everolimus or other similar medications, unless you stopped for reasons other than your condition getting worse.You have a serious and urgent medical need that requires chemotherapy.You have only had one round of chemotherapy for advanced breast cancer.You are able to perform daily activities with little to no difficulty.Your organs need to work well, as shown by specific blood test results.You have advanced or spreading breast cancer that has not responded to a specific combination of medications.You have advanced or spread-out breast cancer with spots that can or cannot be measured.You have specific mutations in the ESR1 gene that can be detected in a blood test.You have a history of long QTC syndrome or a QTC measurement of more than 480 milliseconds.You have cancer that has spread to your brain.Cancer has spread to the lungs.You have previously tested positive for HIV, HBV, or HCV.You can be either before or after menopause.Women who have gone through menopause or have had their ovaries removed.You have had a blood clot in your lungs or legs in the past 6 months, or have a condition that makes blood clots more likely.You have had cancer, except for breast cancer, in the last 5 years.You have experienced vaginal bleeding in the past year, unless it was caused by something other than the uterus.Your high blood pressure is not under control.You have a history of not following your doctor's instructions for taking medicine.You need to have a biopsy to confirm your cancer is estrogen receptor positive and HER2 negative, or the tissue obtained at the time of your original diagnosis confirms this.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant
- Group 2: Lasofoxifene
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.
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