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Compares treatment options for Metastatic Breast Cancer
Official title Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
ClinicalTrials.gov ID: NCT05696626
What this study is testing
What is Lasofoxifene in combination with abemaciclib?
Lasofoxifene in combination with abemaciclib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre- or postmenopausal women or men.
- Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either...
- Histological or cytological confirmation of ER+/HER2 - disease
- No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.
- 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...
You likely can't join if
- Lymphangitic carcinomatosis involving the lung.
- History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
- Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
- Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
- people with a known hypersensitivity to fulvestrant or to any of the excipients
- Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of...
See the full eligibility criteria
Who can join
- Pre- or postmenopausal women or men.
- Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic...
- Histological or cytological confirmation of ER+/HER2 - disease
- No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.
- 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.
- Locally advanced or metastatic breast cancer with at least 1 measurable (according to RECIST 1.1) lesion with or without non-measurable lesions.
- people may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral...
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Adequate organ function
- Able to swallow tablets
- Brain metastases are allowed only if the following 4 parameters hold:
- Asymptomatic,
- Definitively treated (e.g., radiotherapy, surgery),
- Not requiring steroids up to 4 weeks before study treatment initiation, AND
- Central nervous system disease stable for \>3 months prior to registration as documented by magnetic resonance imagining (MRI).
- Able to understand and voluntarily sign a written informed consent before any screening procedures.
- Every attempt should be made to obtain a biopsy of metastatic breast cancer tissue, when safe and feasible, to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory...
What rules you out
- Lymphangitic carcinomatosis involving the lung.
- History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
- Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
- Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
- people with a known hypersensitivity to fulvestrant or to any of the excipients
- Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0...
- Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)
- History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of \>480 msec.
- History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia, unless the event occurred greater than 6 months prior to screening and the subject is treated with chronic anticoagulant...
- Lasofoxifene is not recommended for use in people with conditions that place them at increased risk for VTEs (such as severe congestive heart failure [CHF] or prolonged immobilization).
- On concomitant strong CYP3A4 inhibitors.
- On strong and moderate CYP3A4 inducers.
- Any significant co-morbidity that would impact the study or the subject's safety, including people with significant malabsorption.
- Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment).
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.
- Positive serum pregnancy test (only if premenopausal).
- Sexually active premenopausal women and men unwilling to use double-barrier contraception.
- Women who are breast feeding
- History of non-compliance to medical regimens.
- Unwilling or unable to comply with the protocol.
- Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
- people with a history of familial hypertriglyceridemia or fasting triglyceride levels \>880 mg/dL at screening.
- Fasting triglyceride level \>300 mg/dL and ≤880 mg/dL at screening. people may be retested and enrolled if they have a repeat fasting triglyceride level less than or equal to 300 mg/dL prior to enrollment (e.g., after...
- Fasting cholesterol level \>400 mg/dL at screening. people may be retested and enrolled if they have a repeat fasting cholesterol level less than or equal to 400 mg/dL prior to enrollment (e.g., after adjustment with...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Santa Rosa, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
- Belleville, New Jersey, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- Rio Rancho, New Mexico, United States
+ 158 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Santa Rosa, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Plantation, Florida, United States and 172 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.