RECRUITING

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Official Title

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Quick Facts

Study Start:2023-01-24

Study Completion:2028-12-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05563220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant has signed the informed consent before all study specific activities are conducted. 2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female participants may be of any menopausal status. * Postmenopausal status is defined as follows or in accordance with local regulations: 1. Age ≥60 years or 2. Age \<60 years and amenorrhea for 12 or more months (without an alternative cause) and follicle-stimulating hormone value and an estradiol level within the postmenopausal range per local laboratory reference or 3. Documentation of bilateral oophorectomy, at least 1 month before first dose of trial therapy. * Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be receiving a luteinizing hormone-releasing hormone (LHRH) agonist and must be initiated at least 3 weeks (4 depending on local label) before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment. 3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology/College of American Pathologists guidelines. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone positivity. 4. Documented radiological disease progression during or after the most recent therapy. 5. At least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Tumor lesions previously irradiated or subjected to any locoregional treatment will only be considered measurable if there is clear, documented progression at the treated site. For participants with bone only disease, lesions: must be lytic or mixed (lytic + blastic / sclerotic), confirmed and accurately assessed by computed tomography or magnetic resonance imaging, and must have an identifiable soft tissue component meeting the definition of measurability per RECIST v1.1. Note: participants with blastic / sclerotic bone lesions only are not eligible. 6. Eastern Cooperative Oncology Group performance status of 0 or 1. 7. Participant has adequate bone marrow and organ function, as defined by the following laboratory values: 1. Absolute neutrophil count ≥1.5 × 10\^9/liter (L) 2. Platelets ≥100 × 10\^9/L 3. Hemoglobin ≥9.0 grams/deciliter (g/dL) 4. Creatinine is ≤ 1.5 x upper limit of normal (ULN) or if creatinine is \> 1.5 x ULN, then creatinine clearance must be ≥50 milliliters/minute based on the Cockcroft-Gault formula. Note: C-G formula: * Creatinine clearance (male) = (\[140-age in years\] × weight in kilograms \[kg\])/ (\[serum creatinine in milligrams/deciliter (mg/dL)\] × 72) * Creatinine clearance (female) = (0.85 × \[140-age in years\] × weight in kg)/ (\[serum creatinine in mg/dL\] × 72) 1. Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment. 2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a cyclin-dependent kinase targeting enzymes CDK4 and CDK6 (CDK4/6) inhibitor. 1. PIK3CA/AKT1/PTEN-alteration as detected by an FDA and/or locally approved test (local result). 2. One or up to two prior hormonal therapies in the advanced or metastatic setting or participants who have radiological evidence of breast cancer recurrence or progression within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first line relapsed participants. Prior CDK4/6i treatment is allowed but not required.	1. Active or newly diagnosed central nervous system metastases, or meningeal carcinomatosis. Note: Participants with stable brain or subdural metastases are allowed if the participant has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (for example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. 2. Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%. 3. Prior chemotherapy or elacestrant in the advanced/metastatic setting. 4. Participants with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry. 5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders, or investigational alike agents such as selective estrogen receptor modulators, selective estrogen receptor covalent antagonists, complete estrogen receptor antagonists, and proteolysis-targeting chimeras, in the metastatic setting. Prior treatment with fulvestrant is not exclusionary, except for Arm E, as it is an approved medication. 6. Participant has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval. 7. Uncontrolled significant active infections. * Participants with hepatitis B virus and/or hepatitis C virus infection must have undetectable viral load during screening. * Participants known to be human immunodeficiency virus+ are allowed if they have undetectable viral load at baseline. 8. Documented pneumonitis/interstitial lung disease prior to Cycle 1 Day 1. 9. Major surgery within 28 days before starting trial therapy. 10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug. 11. Known intolerance to elacestrant or any of its excipients. 12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who: * Within 28 days before starting trial therapy, did not use a highly effective method of contraception. * Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation. 13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, 28 days prior, during the course of the treatment period and for 120 days after the last dose of study treatment. 14. Participant is currently receiving or received any of the following medications prior to first dose of trial therapy: * Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to https://drug-interactions.medicine.iu.edu/maintable.aspx or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers). * Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng. * Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to starting trial therapy. 15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator. 16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant's participation in a clinical study. 1. Prior therapy with alpelisib or any other phosphoinositide 3-kinase (PI3K) inhibitor. 2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of \>140 mg/dL \[7.7 millimole (mmol)/L\], or glycosylated hemoglobin \[HbA1c\] level of \>6.4%). 3. Known intolerance to alpelisib or any of its excipients. 4. Participant is currently receiving or received drugs known to be a breast cancer resistant protein inhibitor (for example, curcumin, cyclosporine A, eltrombopag, febuxostat, fostamatinib, rolapitant, teriflunomide) within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy (refer to Table 5.2 of https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers). 5. Participant has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab 1. Prior therapy with everolimus. 2. Known intolerance to everolimus or any of its excipients. 1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is also exclusionary. 2. Known intolerance to abemaciclib or any of its excipients. 3. History of deep vein thrombosis or pulmonary embolism (unless on anticoagulation), cerebrovascular accident, or myocardial infarction, in the past 6 months. Participants on anticoagulation should have been on a stable dose for at least 3 months prior to enrollment. 1. Prior therapy with ribociclib in the advanced or metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary. 2. Known intolerance to ribociclib or any of its excipients. 3. QTcF interval corrected by Fridericia formula (QTcF) values ≥450 milliseconds (msec). 4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with: * Long QT syndrome * Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias * Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1 5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy. 1. Prior therapy with palbociclib in the advanced or metastatic setting. 2. Known intolerance to palbociclib or any of its excipients 1. Prior therapy with a CDK4/6i in the metastatic setting. 2. Known intolerance to palbociclib or any of its excipients. 1. Prior therapy with any CDK4/6i. 2. Known intolerance to abemaciclib or any of its excipients. 1. Prior therapy with a CDK4/6i in the advanced or metastatic setting. 2. Known intolerance to ribociclib or any of its excipients. 3. QTcF values ≥450 msec. 4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with: * Long QT syndrome * Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias * Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1 5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy. 1. Prior treatment with any of the following: AKT, PI3K and mammalian target of rapamycin inhibitors and, for Arm E, fulvestrant. 2. Known intolerance to capivasertib or any of its excipients. 3. QTcF values ≥470 msec or factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval. 4. Clinically significant abnormalities of glucose metabolism as defined by any of the following: Participants with diabetes mellitus type 1; participants with diabetes mellitus type 2 requiring insulin treatment or participants with HbA1c level of \>8.0% (63.9 mmol/mol).

Inclusion Criteria

Exclusion Criteria

1. Participant has signed the informed consent before all study specific activities are conducted.
2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female participants may be of any menopausal status.
* Postmenopausal status is defined as follows or in accordance with local regulations:
1. Age ≥60 years or
2. Age \<60 years and amenorrhea for 12 or more months (without an alternative cause) and follicle-stimulating hormone value and an estradiol level within the postmenopausal range per local laboratory reference or
3. Documentation of bilateral oophorectomy, at least 1 month before first dose of trial therapy.
* Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be receiving a luteinizing hormone-releasing hormone (LHRH) agonist and must be initiated at least 3 weeks (4 depending on local label) before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology/College of American Pathologists guidelines. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone positivity.
4. Documented radiological disease progression during or after the most recent therapy.
5. At least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Tumor lesions previously irradiated or subjected to any locoregional treatment will only be considered measurable if there is clear, documented progression at the treated site. For participants with bone only disease, lesions: must be lytic or mixed (lytic + blastic / sclerotic), confirmed and accurately assessed by computed tomography or magnetic resonance imaging, and must have an identifiable soft tissue component meeting the definition of measurability per RECIST v1.1. Note: participants with blastic / sclerotic bone lesions only are not eligible.
6. Eastern Cooperative Oncology Group performance status of 0 or 1.
7. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
1. Absolute neutrophil count ≥1.5 × 10\^9/liter (L)
2. Platelets ≥100 × 10\^9/L
3. Hemoglobin ≥9.0 grams/deciliter (g/dL)
4. Creatinine is ≤ 1.5 x upper limit of normal (ULN) or if creatinine is \> 1.5 x ULN, then creatinine clearance must be ≥50 milliliters/minute based on the Cockcroft-Gault formula. Note: C-G formula:
* Creatinine clearance (male) = (\[140-age in years\] × weight in kilograms \[kg\])/ (\[serum creatinine in milligrams/deciliter (mg/dL)\] × 72)
* Creatinine clearance (female) = (0.85 × \[140-age in years\] × weight in kg)/ (\[serum creatinine in mg/dL\] × 72)
1. Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.
2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a cyclin-dependent kinase targeting enzymes CDK4 and CDK6 (CDK4/6) inhibitor.
1. PIK3CA/AKT1/PTEN-alteration as detected by an FDA and/or locally approved test (local result).
2. One or up to two prior hormonal therapies in the advanced or metastatic setting or participants who have radiological evidence of breast cancer recurrence or progression within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first line relapsed participants. Prior CDK4/6i treatment is allowed but not required.

1. Active or newly diagnosed central nervous system metastases, or meningeal carcinomatosis. Note: Participants with stable brain or subdural metastases are allowed if the participant has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (for example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
2. Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%.
3. Prior chemotherapy or elacestrant in the advanced/metastatic setting.
4. Participants with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry.
5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders, or investigational alike agents such as selective estrogen receptor modulators, selective estrogen receptor covalent antagonists, complete estrogen receptor antagonists, and proteolysis-targeting chimeras, in the metastatic setting. Prior treatment with fulvestrant is not exclusionary, except for Arm E, as it is an approved medication.
6. Participant has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval.
7. Uncontrolled significant active infections.
* Participants with hepatitis B virus and/or hepatitis C virus infection must have undetectable viral load during screening.
* Participants known to be human immunodeficiency virus+ are allowed if they have undetectable viral load at baseline.
8. Documented pneumonitis/interstitial lung disease prior to Cycle 1 Day 1.
9. Major surgery within 28 days before starting trial therapy.
10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug.
11. Known intolerance to elacestrant or any of its excipients.
12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who:
* Within 28 days before starting trial therapy, did not use a highly effective method of contraception.
* Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation.
13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, 28 days prior, during the course of the treatment period and for 120 days after the last dose of study treatment.
14. Participant is currently receiving or received any of the following medications prior to first dose of trial therapy:
* Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to https://drug-interactions.medicine.iu.edu/maintable.aspx or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).
* Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng.
* Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to starting trial therapy.
15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator.
16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant's participation in a clinical study.
1. Prior therapy with alpelisib or any other phosphoinositide 3-kinase (PI3K) inhibitor.
2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of \>140 mg/dL \[7.7 millimole (mmol)/L\], or glycosylated hemoglobin \[HbA1c\] level of \>6.4%).
3. Known intolerance to alpelisib or any of its excipients.
4. Participant is currently receiving or received drugs known to be a breast cancer resistant protein inhibitor (for example, curcumin, cyclosporine A, eltrombopag, febuxostat, fostamatinib, rolapitant, teriflunomide) within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy (refer to Table 5.2 of https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).
5. Participant has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab
1. Prior therapy with everolimus.
2. Known intolerance to everolimus or any of its excipients.
1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is also exclusionary.
2. Known intolerance to abemaciclib or any of its excipients.
3. History of deep vein thrombosis or pulmonary embolism (unless on anticoagulation), cerebrovascular accident, or myocardial infarction, in the past 6 months. Participants on anticoagulation should have been on a stable dose for at least 3 months prior to enrollment.
1. Prior therapy with ribociclib in the advanced or metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF interval corrected by Fridericia formula (QTcF) values ≥450 milliseconds (msec).
4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with:
* Long QT syndrome
* Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
* Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1
5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.
1. Prior therapy with palbociclib in the advanced or metastatic setting.
2. Known intolerance to palbociclib or any of its excipients
1. Prior therapy with a CDK4/6i in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients.
1. Prior therapy with any CDK4/6i.
2. Known intolerance to abemaciclib or any of its excipients.
1. Prior therapy with a CDK4/6i in the advanced or metastatic setting.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.
4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with:
* Long QT syndrome
* Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
* Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1
5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.
1. Prior treatment with any of the following: AKT, PI3K and mammalian target of rapamycin inhibitors and, for Arm E, fulvestrant.
2. Known intolerance to capivasertib or any of its excipients.
3. QTcF values ≥470 msec or factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval.
4. Clinically significant abnormalities of glucose metabolism as defined by any of the following: Participants with diabetes mellitus type 1; participants with diabetes mellitus type 2 requiring insulin treatment or participants with HbA1c level of \>8.0% (63.9 mmol/mol).

Contacts and Locations

Study Contact

Stemline Trials

CONTACT

1-877-332-7961

clinicaltrials@menarinistemline.com

Study Locations (Sites)

Dothan Hematology and Oncology

Dothan, Alabama, 36303

United States

Mayo Clinic - Arizona

Phoenix, Arizona, 85054

United States

Highlands Oncology Group

Springdale, Arkansas, 72762

United States

OPN Healthcare (Arcadia Location)

Arcadia, California, 91007

United States

Glendale Adventist

Glendale, California, 91206

United States

OPN Healthcare (Los Alamitos Location)

Los Alamitos, California, 90720

United States

Cedars Sinai

Los Angeles, California, 90048

United States

UCLA UCLA Hem/Onc - Clinical Research Unit

Los Angeles, California, 90095

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158

United States

TOI Clinical Research

Whittier, California, 90603

United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124

United States

Yale School Of Medicine - Smilow Cancer Hospital - Breast Center

New Haven, Connecticut, 06519

United States

George Washington Cancer Center

Washington, District of Columbia, 20037

United States

Advent Health (Florida Hospital) - Altamonte Springs

Altamonte Springs, Florida, 32701

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224

United States

Ocala Oncology

Ocala, Florida, 34474

United States

Northside Hospital Atlanta Cancer Care

Cumming, Georgia, 30041

United States

Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital

Chicago, Illinois, 60611

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804

United States

MD Alliance for Multispecialty Research, LLC

Merriam, Kansas, 66204

United States

New England Cancer Specialists

Scarborough, Maine, 04074

United States

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Washington University School of Medicine in St. Louis

Saint Louis, Missouri, 63110

United States

Astera Cancer Care

East Brunswick, New Jersey, 08816

United States

Summit Medical Group

Florham Park, New Jersey, 07932

United States

Cooperman Barnabas Medical Center

New Brunswick, New Jersey, 08901

United States

NYU Langone Health

New York, New York, 10016

United States

New York Cancer and Blood Specialists

Port Jefferson Station, New York, 11776

United States

W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905

United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, 37203

United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

United States

MD Anderson Cancer Center Texas

Houston, Texas, 77030

United States

UT Health San Antonio

San Antonio, Texas, 78229

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Virginia Oncology Associates

Norfolk, Virginia, 23502

United States

Cancer Care Northwest

Spokane Valley, Washington, 99216

United States

Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC

Tacoma, Washington, 98405

United States

University of WI - Carbone Cancer Center (Phase II only)

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Stemline Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-24

Study Completion Date2028-12-28

Study Record Updates

Study Start Date2023-01-24

Study Completion Date2028-12-28

Terms related to this study

Keywords Provided by Researchers

breast cancer

Additional Relevant MeSH Terms

Breast Cancer
Metastatic Breast Cancer