Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advancedbreast cancer Adult females, pre- and/or post-menopausal, and adult males.Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatmentwith an LHRH agonist. Patients are to have commenced concomitant treatment with LHRHagonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for theduration of the study.
- Negative pregnancy test for women who are not surgically sterile. Female subjects whoare not surgically sterile must use a medically-effective contraceptive method fromscreening until 1 year after the last dose of study treatment
- Confirmed diagnosis of estrogen receptor positive and/or progesterone receptorpositive, as per American Society of Clinical Oncology/College of AmericanPathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizingan assay consistent with local standards
- Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
- Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
- Subject has radiologically evaluable disease (measurable and/or non-measurable)according to RECIST v1.1, per local assessment. Mixed lytic/blastic or lytic lesionswith measurable soft tissue component are allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidalaromatase inhibitor (AI)
- Adequate bone marrow, hepatic, renal and coagulation function
Exclusion
Exclusion Criteria:
- History of malignancies other than adequately treated non-melanoma skin cancer,curatively treated in situ cancer of the cervix, or other solid tumors curativelytreated with no evidence of disease for ≥3 years
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
- More than one prior treatment with chemotherapy for advanced disease (prior adjuvantor neoadjuvant chemotherapy is permitted)
- More than 2 lines of prior endocrine therapy treatment
- Bone only disease that is only blastic with no soft tissue component
- Subjects with type 1 diabetes or uncontrolled type 2 diabetes
- Known and untreated, or active, brain or leptomeningeal metastases a. Subjects with previously treated central nervous system (CNS) metastases may beenrolled in the study if they meet the following criteria: do not require supportivetherapy with steroids; do not have seizures and do not exhibit uncontrolledneurological symptoms; stable disease confirmed by radiographic assessment within atleast 4 weeks prior to enrollment
- Patients with advanced, symptomatic, visceral spread that are at risk oflife-threatening complication in the short-term
- History of clinically significant cardiovascular abnormalities such as: Congestiveheart failure (New York Heart Association (NYHA) classification ≥ II within 6 monthsof study entry
- Myocardial infarction within 12 months of study entry
- History of any cardiac arrhythmias, (e.g., ventricular tachycardia), completeleft bundle branch block, high grade AV block (e.g., bifascicular block, Mobitztype II and third degree AV block), supraventricular, nodal arrhythmias, orconduction abnormality in the previous 12 months
- Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHgand/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensivemedication (initiation or adjustment of antihypertensive medication[s] is allowedprior to screening)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QTsyndrome, or any of the following:
- i. Risk factors for Torsades de Pointes (TdP) including uncorrectedhypokalemia or hypomagnesemia, history of cardiac failure, or history ofclinically significant/symptomatic bradycardia
- ii. Concomitant medication(s) with a known risk to prolong the QT intervaland/or known to cause TdP that cannot be discontinued or replaced by safealternative medication
- iii. Bradycardia (heart rate <50 beats per minute at rest) byelectrocardiogram (ECG) or pulse
- iv. On screening, inability to determine the corrected QT interval usingFridericia's formula (QTcF) on the ECG (i.e., unreadable or notinterpretable) or QTcF >450 msec for males and >460 msec for females (determined by mean of triplicate ECGs at screening)
- Known hypersensitivity to the study drugs or their components
- Pregnant or breast-feeding women
- Concurrent participation in another clinical trial
- Subjects must agree not to participate in another clinical trial at any timeduring participation in VIKTORIA-1.
Study Design
Study Description
Connect with a study center
Buenos Aires British Hospital
Buenos Aires,
ArgentinaSite Not Available
Center for Medical Education and Clinical Research (CEMIC)
Buenos Aires,
ArgentinaSite Not Available
Fleischer Medical Center
Buenos Aires,
ArgentinaSite Not Available
Medical Center Austral
Buenos Aires,
ArgentinaSite Not Available
Cordoba Oncology Institute (IONC)
Córdoba,
ArgentinaSite Not Available
Pergamino Clinic
Pergamino,
ArgentinaSite Not Available
Rosario's Oncology Institute and Medical Specialities (IOR)
Rosario,
ArgentinaSite Not Available
CER San Juan
San Juan,
ArgentinaSite Not Available
9 of July Sanatorium
San Miguel De Tucumán,
ArgentinaSite Not Available
Adelaide Oncology & Haematology
Adelaide,
AustraliaSite Not Available
Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)
Frankston,
AustraliaSite Not Available
St Vincent's Hospital (Melbourne) Ltd
Melbourne,
AustraliaSite Not Available
Hollywood Private Hospital, Breast Cancer Research Centre
Nedlands,
AustraliaSite Not Available
Mater Hospital Brisbane, Mater Cancer Care Centre
South Brisbane,
AustraliaSite Not Available
Icon Cancer Centre- Southport
Southport,
AustraliaSite Not Available
Sydney Adventist Hospital
Wahroonga,
AustraliaSite Not Available
The Queen Elizabeth Hospital
Woodville,
AustraliaSite Not Available
Catarina Clinical Research
Itajaí,
BrazilSite Not Available
D'OR Institute
São Paulo,
BrazilSite Not Available
Hospital A.C.Camargo
São Paulo,
BrazilSite Not Available
CRYPTEX
Mexico City,
MexicoSite Not Available
Clinical Research Center Chapultepec Mexico City
Mexico City,
MexicoSite Not Available
ProcliniQ Clinical Research
Mexico City,
MexicoSite Not Available
Avix Clinical Research
Monterrey,
MexicoSite Not Available
Administrative Society of Health Services, SC
Morelia,
MexicoSite Not Available
Inbiomedyc
Querétaro,
MexicoSite Not Available
ONCOR Life Medical Center
Saltillo,
MexicoSite Not Available
Zambrano Hellion Medical Center
San Pedro Garza Garcia,
MexicoSite Not Available
Curie Oncology
Singapore,
SingaporeSite Not Available
ICON SOC Farrer Park Medical Clinic
Singapore,
SingaporeSite Not Available
OncoCare Cancer Centre
Singapore,
SingaporeSite Not Available
Raffles Hospital
Singapore,
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore,
SingaporeSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
St. Bernards Medical Center
Jonesboro, Arkansas 72401
United StatesSite Not Available
CARTI Cancer Center
Little Rock, Arkansas 72205
United StatesSite Not Available
Providence Medical Foundation - Providence St. Joseph
Fullerton, California 92835
United StatesSite Not Available
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
University of California, Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Ventura County Hematology Oncology Specialists
Oxnard, California 93030
United StatesSite Not Available
Torrance Memorial Physician Network
Redondo Beach, California 90277
United StatesSite Not Available
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United StatesSite Not Available
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California 90404
United StatesSite Not Available
Innovative Clinical Research Institute, LLC - Whittier
Whittier, California 90603
United StatesSite Not Available
PIH Health Hospital Whittier
Whittier, California 90602
United StatesSite Not Available
Yale Cancer Center - New Haven
New Haven, Connecticut 06520
United StatesSite Not Available
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida 32256
United StatesSite Not Available
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
Bond Clinic, P.A.
Winter Haven, Florida 33881,
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesSite Not Available
American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
University of Missouri Health Care
Columbia, Missouri 65212
United StatesSite Not Available
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska 68506
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Clinical Research Alliance, Inc.
New York, New York 10021
United StatesSite Not Available
Weill Cornell Medicine/New York-Presbyterian Hospital
New York, New York 10065
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
Greensboro, North Carolina 27403,
United StatesSite Not Available
Bon Secours Mercy Health
Cincinnati, Ohio 45237
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
OSU Gynecologic Oncology at Mill Run
Hilliard, Ohio 14642
United StatesSite Not Available
William Beaumont Army Medical Center
El Paso, Texas 79920
United StatesSite Not Available
Brooke Army Medical Center
Houston, Texas 78234
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Fort Belvoir Community Hospital
Fort Belvoir, Virginia 22060
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesSite Not Available
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