Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
NCT ID: NCT03781063
Last Updated: 2024-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-20
Study Completion Date
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor.
The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with 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 secondary objectives are to evaluate:
1. Clinical benefit rate (CBR) and Objective Response Rate (ORR)
2. Duration of response
3. Time to response
4. Overall Survival (OS)
5. Pharmacokinetics of lasofoxifene
6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires
7. Safety of lasofoxifene
8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).
The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with 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 secondary objectives are to evaluate:
1. Clinical benefit rate (CBR) and Objective Response Rate (ORR)
2. Duration of response
3. Time to response
4. Overall Survival (OS)
5. Pharmacokinetics of lasofoxifene
6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires
7. Safety of lasofoxifene
8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
NCT02374099
Breast Neoplasms
TERMINATED
PHASE2
Efficacy and Safety of 500mg of Fulvestrant
NCT00585507
Breast Cancer
ACTIVE_NOT_RECRUITING
PHASE2
Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
NCT00871858
Breast Cancer
COMPLETED
PHASE2
Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy
NCT00688194
Breast Cancer
UNKNOWN
PHASE3
Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.
NCT03236974
Postmenopausal Women With ER+ HER2- Primary Breast Cancer
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Lasofoxifene is a potent SERM that has demonstrated in non-clinical models to prevent and treat breast cancer. In a large clinical osteoporosis trial, lasofoxifene reduced the incidence of ER+ breast cancer, which most likely represents a beneficial effect on clinically undetectable breast cancer. The clinical and non-clinical results are not unexpected based on the results seen with tamoxifen and fulvestrant as the mechanisms of action are similar. Moreover, the safety profile of lasofoxifene is well established in postmenopausal women and therefore a clinical trial investigating lasofoxifene for the treatment of breast cancer is scientifically justifiable.
Subjects with ESR1 mutations have endocrine resistance and shorter time to progression when treated with currently approved endocrine therapy. There is an unmet medical need for endocrine agents that can provide greater efficacy in this population. Non-clinical in vitro and in vivo studies with lasofoxifene have demonstrated efficacy. If this benefit translates to subjects with ESR1 mutated breast cancer cells, an important treatment option beyond fulvestrant will be available. The population being recruited in this trial are subjects with advanced breast cancer who have been treated with an AI in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor and who have an ESR1 mutation. The efficacy of endocrine agents in this population has never been prospectively studied. For this reason, this study will evaluate lasofoxifene in a randomized Phase 2 trial against a comparator to better evaluate the magnitude of the effect as well as to provide data to estimate the Phase 3 sample size.
In both non-clinical and clinical studies, fulvestrant has shown activity in ESR1 mutated breast cancer cells and will be used as the comparator in this Phase 2 study to better determine the relative clinical efficacy of lasofoxifene. The FDA approved fulvestrant dose will be used.
A major limiting factor in the administration of fulvestrant is its poor solubility requiring IM injection. The volume of administration limits the dose that can be administered. Initial clinical trials administered 250 mg of fulvestrant in 5 cc of castor oil as a single injection once monthly. Because the IM injections were well tolerated, loading and higher doses were investigated. This was found to have acceptable tolerability and resulted in greater efficacy. Limited by the volume of administration higher doses of fulvestrant cannot be investigated further.
Once the subject has consented to participate in the study, screening tests will be performed within 30 days of enrollment.
All subjects meeting the eligibility criteria will be first stratified into those with visceral metastasis and those without visceral metastasis. Each of these stratified groups will then be further stratified into those with the Y537S ESR1 mutation and those without this particular mutation. Each of the stratified groups will then be randomized 1:1 to receive either 5 mg/d of oral lasofoxifene or fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29, then every 4 weeks thereafter. Treatment will continue until radiographic or clinical evidence of disease progression. Enrolled subjects will be seen every 2 weeks for the first month of treatment and then monthly until progression. Efficacy assessments will be done every 8 weeks.
For subjects randomized to lasofoxifene, blood samples will be drawn to assess the population PK. Serum samples will be collected at each visit starting at Visit 0 (Day 1) through Final/ET visit to measure serum lasofoxifene concentration at time points outlined below. Serum samples for PK analysis will be collected before the time that the next lasofoxifene dose is ingested. The actual time and date of dosing on the previous day as well as dosing on the visit day, and the PK blood sampling time/date must be recorded for all subjects. Pharmacokinetic samples are to be collected before clinical lab blood sampling.
A maximum of 100 subjects will be randomized and it is expected that all subjects enrolled in the study will be treated until documented disease progression. It is estimated that full recruitment into the study will occur within 12 to 18 months with another 12 months of follow up before the primary outcome measure is analyzed.
Subjects with ESR1 mutations have endocrine resistance and shorter time to progression when treated with currently approved endocrine therapy. There is an unmet medical need for endocrine agents that can provide greater efficacy in this population. Non-clinical in vitro and in vivo studies with lasofoxifene have demonstrated efficacy. If this benefit translates to subjects with ESR1 mutated breast cancer cells, an important treatment option beyond fulvestrant will be available. The population being recruited in this trial are subjects with advanced breast cancer who have been treated with an AI in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor and who have an ESR1 mutation. The efficacy of endocrine agents in this population has never been prospectively studied. For this reason, this study will evaluate lasofoxifene in a randomized Phase 2 trial against a comparator to better evaluate the magnitude of the effect as well as to provide data to estimate the Phase 3 sample size.
In both non-clinical and clinical studies, fulvestrant has shown activity in ESR1 mutated breast cancer cells and will be used as the comparator in this Phase 2 study to better determine the relative clinical efficacy of lasofoxifene. The FDA approved fulvestrant dose will be used.
A major limiting factor in the administration of fulvestrant is its poor solubility requiring IM injection. The volume of administration limits the dose that can be administered. Initial clinical trials administered 250 mg of fulvestrant in 5 cc of castor oil as a single injection once monthly. Because the IM injections were well tolerated, loading and higher doses were investigated. This was found to have acceptable tolerability and resulted in greater efficacy. Limited by the volume of administration higher doses of fulvestrant cannot be investigated further.
Once the subject has consented to participate in the study, screening tests will be performed within 30 days of enrollment.
All subjects meeting the eligibility criteria will be first stratified into those with visceral metastasis and those without visceral metastasis. Each of these stratified groups will then be further stratified into those with the Y537S ESR1 mutation and those without this particular mutation. Each of the stratified groups will then be randomized 1:1 to receive either 5 mg/d of oral lasofoxifene or fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29, then every 4 weeks thereafter. Treatment will continue until radiographic or clinical evidence of disease progression. Enrolled subjects will be seen every 2 weeks for the first month of treatment and then monthly until progression. Efficacy assessments will be done every 8 weeks.
For subjects randomized to lasofoxifene, blood samples will be drawn to assess the population PK. Serum samples will be collected at each visit starting at Visit 0 (Day 1) through Final/ET visit to measure serum lasofoxifene concentration at time points outlined below. Serum samples for PK analysis will be collected before the time that the next lasofoxifene dose is ingested. The actual time and date of dosing on the previous day as well as dosing on the visit day, and the PK blood sampling time/date must be recorded for all subjects. Pharmacokinetic samples are to be collected before clinical lab blood sampling.
A maximum of 100 subjects will be randomized and it is expected that all subjects enrolled in the study will be treated until documented disease progression. It is estimated that full recruitment into the study will occur within 12 to 18 months with another 12 months of follow up before the primary outcome measure is analyzed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Locally Advanced or Metastatic Breast Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
open label, randomized, parallel-group, multicenter study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lasofoxifene
5 mg/d of oral lasofoxifene
Group Type
EXPERIMENTAL
Lasofoxifene
Intervention Type
DRUG
Estrogen receptor antagonist antineoplastic agent
Fulvestrant
500 mg fulvestrant intramuscular (IM)
Group Type
ACTIVE_COMPARATOR
Fulvestrant
Intervention Type
DRUG
Estrogen receptor antagonist antineoplastic agent
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lasofoxifene
Estrogen receptor antagonist antineoplastic agent
Intervention Type
DRUG
Fulvestrant
Estrogen receptor antagonist antineoplastic agent
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Pre- or postmenopausal.
Postmenopausal women are defined as:
1. ≥60 years of age with no vaginal bleeding over the prior year, or
2. \<60 years with "premature menopause" or "premature ovarian failure" manifest itself with secondary amenorrhea for at least 1 year and follicle stimulating hormone (FSH) and estradiol levels in the postmenopausal range according to institutional standards, or
3. surgical menopause with bilateral oophorectomy. Note: premenopausal women who meet all of the other entry criteria must be maintained on ovarian suppression (such as Lupron) during the study and subjects counseled to use appropriate contraception to prevent pregnancy.
2. If possible, a biopsy of metastatic breast cancer tissue will be obtained to provide histological or cytological confirmation of ER+ and HER2- disease as assessed by a local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is not possible, the ER and HER2 status from the tissue obtained at the time of the original diagnosis must confirm that the subject's cancer is ER+ and HER2-.
3. Locally advanced or metastatic breast cancer with radiological or clinical evidence of progression on an AI in combination with a CDK 4/6 inhibitor for advanced breast cancer with demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in the metastatic setting).
4. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
5. At least one or more of the following point ESR1 mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood (plasma) or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. The ctDNA sample collection must be obtained within 30 days prior to randomization to determine eligibility and baseline. Note: a prior genomic test confirming that the subject has an ESR1 mutation can be used to determine eligibility; however, an ESR1 sample must also be collected within 30 days of randomization.
6. Subjects who have not received cytotoxic chemotherapy or those who have received one cytotoxic chemotherapy regimen in the neo-adjuvant or adjuvant setting prior to entry into the trial and/or no more than one chemotherapy regimen for metastatic breast cancer. Subjects must be free of all chemotherapy acute toxicity excluding alopecia and Grade II peripheral neuropathy before study entry.
7. ECOG performance score of 0 or 1.
8. Adequate organ function as shown by:
1. absolute neutrophil count (ANC) \>/=1,500 cells/mm3
2. platelet count ≤100,000 cells/mm3
3. hemoglobin \>/=9.0 g/dl
4. ALT and AST levels ≤2.5 upper limit of normal (ULN) or ≤5 in the presence of visceral metastasis
5. total serum bilirubin ≤1.5 X ULN (≤ 3 X ULN for subjects known to have Gilbert Syndrome)
6. alkaline phosphatase level ≤ 2.5 X ULN
7. creatinine clearance of 40 ml/min or greater as calculated by the Cockcroft-Gault formula
8. International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) \<2.0 X ULN.
9. Able to swallow tablets.
10. Able to understand and voluntarily sign a written informed consent before any screening procedures.
Postmenopausal women are defined as:
1. ≥60 years of age with no vaginal bleeding over the prior year, or
2. \<60 years with "premature menopause" or "premature ovarian failure" manifest itself with secondary amenorrhea for at least 1 year and follicle stimulating hormone (FSH) and estradiol levels in the postmenopausal range according to institutional standards, or
3. surgical menopause with bilateral oophorectomy. Note: premenopausal women who meet all of the other entry criteria must be maintained on ovarian suppression (such as Lupron) during the study and subjects counseled to use appropriate contraception to prevent pregnancy.
2. If possible, a biopsy of metastatic breast cancer tissue will be obtained to provide histological or cytological confirmation of ER+ and HER2- disease as assessed by a local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is not possible, the ER and HER2 status from the tissue obtained at the time of the original diagnosis must confirm that the subject's cancer is ER+ and HER2-.
3. Locally advanced or metastatic breast cancer with radiological or clinical evidence of progression on an AI in combination with a CDK 4/6 inhibitor for advanced breast cancer with demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in the metastatic setting).
4. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
5. At least one or more of the following point ESR1 mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood (plasma) or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. The ctDNA sample collection must be obtained within 30 days prior to randomization to determine eligibility and baseline. Note: a prior genomic test confirming that the subject has an ESR1 mutation can be used to determine eligibility; however, an ESR1 sample must also be collected within 30 days of randomization.
6. Subjects who have not received cytotoxic chemotherapy or those who have received one cytotoxic chemotherapy regimen in the neo-adjuvant or adjuvant setting prior to entry into the trial and/or no more than one chemotherapy regimen for metastatic breast cancer. Subjects must be free of all chemotherapy acute toxicity excluding alopecia and Grade II peripheral neuropathy before study entry.
7. ECOG performance score of 0 or 1.
8. Adequate organ function as shown by:
1. absolute neutrophil count (ANC) \>/=1,500 cells/mm3
2. platelet count ≤100,000 cells/mm3
3. hemoglobin \>/=9.0 g/dl
4. ALT and AST levels ≤2.5 upper limit of normal (ULN) or ≤5 in the presence of visceral metastasis
5. total serum bilirubin ≤1.5 X ULN (≤ 3 X ULN for subjects known to have Gilbert Syndrome)
6. alkaline phosphatase level ≤ 2.5 X ULN
7. creatinine clearance of 40 ml/min or greater as calculated by the Cockcroft-Gault formula
8. International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) \<2.0 X ULN.
9. Able to swallow tablets.
10. Able to understand and voluntarily sign a written informed consent before any screening procedures.
Exclusion Criteria
1. Prior use of everolimus or other mammalian target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinase inhibitor (PI3K) inhibitors is excluded unless discontinued to reasons other than disease progression.
2. Presence of brain metastasis.
3. Lymphangitic carcinomatosis involving the lung.
4. Impending visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
5. Radiotherapy within 30 days prior to randomization 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 randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization.
6. History of long QTC syndrome or a QTC of \>480 ms.
7. History of a pulmonary embolus (PE) or deep vein thrombosis (DVT) within the last 6 months or any known thrombophilia. Subjects stable on anti-coagulants for maintenance are eligible as long as the DVT and/or PE occurred \>6 months prior to enrollment and there is no evidence for active thrombosis. The use of low dose ASA is permitted.
8. Any significant co-morbidity that would impact the study or the subject's safety.
9. History of a positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening. Subjects cured of hepatitis C (no viral load) are eligible.
10. 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, or early stage cervical cancer.
11. History of vaginal bleeding over the last year unless it is documented that the bleeding was due to non-uterine causes (e.g. vaginal atrophy).
12. Uncontrolled hypertension defined as sitting systolic pressure \>160 mm Hg or diastolic pressure \>100 mm Hg at Screening.
13. History of non-compliance to medical regimens.
14. Unwilling or unable to comply with the protocol.
15. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
2. Presence of brain metastasis.
3. Lymphangitic carcinomatosis involving the lung.
4. Impending visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
5. Radiotherapy within 30 days prior to randomization 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 randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization.
6. History of long QTC syndrome or a QTC of \>480 ms.
7. History of a pulmonary embolus (PE) or deep vein thrombosis (DVT) within the last 6 months or any known thrombophilia. Subjects stable on anti-coagulants for maintenance are eligible as long as the DVT and/or PE occurred \>6 months prior to enrollment and there is no evidence for active thrombosis. The use of low dose ASA is permitted.
8. Any significant co-morbidity that would impact the study or the subject's safety.
9. History of a positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening. Subjects cured of hepatitis C (no viral load) are eligible.
10. 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, or early stage cervical cancer.
11. History of vaginal bleeding over the last year unless it is documented that the bleeding was due to non-uterine causes (e.g. vaginal atrophy).
12. Uncontrolled hypertension defined as sitting systolic pressure \>160 mm Hg or diastolic pressure \>100 mm Hg at Screening.
13. History of non-compliance to medical regimens.
14. Unwilling or unable to comply with the protocol.
15. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Linical Accelovance Group
UNKNOWN
Sponsor Role
collaborator
Sermonix Pharmaceuticals Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul V. Plourde, MD
Role: STUDY_DIRECTOR
Sermonix Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Phoenix, Arizona, United States
Site Status
Yuma Regional Medical Center (JIT)
Yuma, Arizona, United States
Site Status
City of Hope Comprehensive Cancer
Duarte, California, United States
Site Status
Compassionate Care Research Group
Fountain Valley, California, United States
Site Status
UCSF Cancer Center
San Francisco, California, United States
Site Status
Rocky Mountain Cancer Centers
Longmont, Colorado, United States
Site Status
Mayo Clinic Florida
Jacksonville, Florida, United States
Site Status
Miami Cancer Institute
Miami, Florida, United States
Site Status
Ocala Oncology Center (JIT)
Ocala, Florida, United States
Site Status
Florida Cancer Specialists
Tallahassee, Florida, United States
Site Status
The Bond Clinic Cancer & Research Center.
Winter Haven, Florida, United States
Site Status
Emory University
Atlanta, Georgia, United States
Site Status
Hawaii Cancer Care (JIT)
Honolulu, Hawaii, United States
Site Status
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Site Status
University of Chicago
Chicago, Illinois, United States
Site Status
Illinois Cancer Care (JIT)
Peoria, Illinois, United States
Site Status
Carle Cancer Center
Urbana, Illinois, United States
Site Status
Beacon Health (JIT)
South Bend, Indiana, United States
Site Status
University of Louisville / James Graham Brown Cancer Center
Louisville, Kentucky, United States
Site Status
FMH James M Stockman Cancer Institute (JIT)
Frederick, Maryland, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Site Status
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Site Status
HCA Midwest Health
Kansas City, Missouri, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Comprehensive Cancer Centers of Nevada (JIT)
Las Vegas, Nevada, United States
Site Status
New Jersey Cancer Care and Blood Disorders (JIT)
Belleville, New Jersey, United States
Site Status
Summit Medical Group (JIT)
Florham Park, New Jersey, United States
Site Status
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
TriHealth Cancer Institute
Cincinnati, Ohio, United States
Site Status
The Ohio State University - Comprehensive Cancer Center
Columbus, Ohio, United States
Site Status
Ohio Health (JIT)
Columbus, Ohio, United States
Site Status
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Site Status
Sanford Cancer Center (JIT)
Sioux Falls, South Dakota, United States
Site Status
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Site Status
West Cancer Center
Germantown, Tennessee, United States
Site Status
Tennessee Oncology/SCRI
Nashville, Tennessee, United States
Site Status
Mary Crowley Cancer Research (JIT)
Dallas, Texas, United States
Site Status
Oncology Consultants (JIT)
Houston, Texas, United States
Site Status
Utah Cancer Specialists (JIT)
Salt Lake City, Utah, United States
Site Status
Peninsula Cancer Institute
Newport News, Virginia, United States
Site Status
The Ottawa Hospital
Ottawa, Ontario, Canada
Site Status
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Site Status
CIUSSS de Saguenay-Lac-Saint Jean
Chicoutimi, Quebec, Canada
Site Status
Jewish General Hospital
Montreal, Quebec, Canada
Site Status
McGill University Health Centre
Montreal, Quebec, Canada
Site Status
Soroka University Medical Center
Beersheba, , Israel
Site Status
Hadassah Ein Kerem Medical Center
Jerusalem, , Israel
Site Status
Rabin Medical Center
Petah Tikva, , Israel
Site Status
Sheba Medical Center
Ramat Gan, , Israel
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Canada
Israel
References
Explore related publications, articles, or registry entries linked to this study.
Goetz MP, Bagegni NA, Batist G, Brufsky A, Cristofanilli MA, Damodaran S, Daniel BR, Fleming GF, Gradishar WJ, Graff SL, Grosse Perdekamp MT, Hamilton E, Lavasani S, Moreno-Aspitia A, O'Connor T, Pluard TJ, Rugo HS, Sammons SL, Schwartzberg LS, Stover DG, Vidal GA, Wang G, Warner E, Yerushalmi R, Plourde PV, Portman DJ, Gal-Yam EN. Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial. Ann Oncol. 2023 Dec;34(12):1141-1151. doi: 10.1016/j.annonc.2023.09.3104.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMX 18001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
NCT00099437
ACTIVE_NOT_RECRUITING
PHASE3
Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women
NCT01300351
COMPLETED
PHASE3
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
NCT00313170
COMPLETED
PHASE2
Overcoming Endocrine Resistance in Metastatic Breast Cancer
NCT02394496
UNKNOWN
PHASE3
A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
NCT00274469
COMPLETED
PHASE2
The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
NCT00065325
COMPLETED
PHASE3
Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer
NCT01992952
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
NCT01602380
ACTIVE_NOT_RECRUITING
PHASE3
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
NCT00357110
COMPLETED
PHASE2
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
NCT00634634
COMPLETED
PHASE1/PHASE2
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
NCT04576455
ACTIVE_NOT_RECRUITING
PHASE2
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer
NCT00878930
COMPLETED
Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
NCT01437566
COMPLETED
PHASE2
Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
NCT02936206
TERMINATED
PHASE1
Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone
NCT02115048
TERMINATED
PHASE2
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
NCT00146601
COMPLETED
PHASE2
Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
NCT00014638
COMPLETED
PHASE4
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
NCT00256698
COMPLETED
PHASE3
Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer
NCT00573755
TERMINATED
PHASE2
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
NCT01171417
COMPLETED
Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study
NCT04256941
TERMINATED
PHASE2
A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer
NCT00241449
COMPLETED
PHASE3
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
NCT00305448
COMPLETED
PHASE2
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
NCT03707340
ACTIVE_NOT_RECRUITING
PHASE2
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
NCT00309478
COMPLETED
PHASE3