Breast Cancer Clinical Trial
— VIKTORIA-1Official title:
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Status | Recruiting |
Enrollment | 701 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study. 2. Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment 3. Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards 4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance 5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status 6. Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 8. Life expectancy of at least 3 months 9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI) 10. Adequate bone marrow, hepatic, renal and coagulation function Exclusion Criteria: 1. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =3 years 2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor 3. Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted) 4. More than 2 lines of prior endocrine therapy treatment 5. Bone only disease that is only blastic with no soft tissue component 6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes 7. Known and untreated, or active, brain or leptomeningeal metastases a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment 8. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term 9. History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification = II within 6 months of study entry 1. Myocardial infarction within 12 months of study entry 2. History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months 3. Uncontrolled hypertension defined by systolic blood pressure (SBP) =160 mmHg and/or diastolic blood pressure (DBP) =100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening) 4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: - i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia - ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening) 10. Known hypersensitivity to the study drugs or their components 11. Pregnant or breast-feeding women 12. Concurrent participation in another interventional clinical trial 1. Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1. |
Country | Name | City | State |
---|---|---|---|
Argentina | Alexander Fleming Institute | Buenos Aires | |
Argentina | Buenos Aires British Hospital | Buenos Aires | |
Argentina | CENIT Foundation | Buenos Aires | |
Argentina | Center for Medical Education and Clinical Research (CEMIC) | Buenos Aires | |
Argentina | Fleischer Medical Center | Buenos Aires | |
Argentina | Medical Center Austral | Buenos Aires | |
Argentina | Pergamino Clinic | Buenos Aires | |
Argentina | Cordoba Oncology Institute (IONC) | Córdoba | |
Argentina | Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER) | Paraná | |
Argentina | CEDIT Diagnostic and treatment center | Salta | |
Argentina | CER San Juan | San Juan | |
Argentina | Rosario's Oncology Institute and Medical Specialities (IOR) | Santa Fe | |
Argentina | 9 of July Sanatorium | Tucumán | |
Australia | Adelaide Oncology & Haematology | Adelaide | |
Australia | St Vincent's Hospital (Melbourne) Ltd | Fitzroy | |
Australia | Peninsula & South Eastern Hematology and Oncology Group (PSEHOG) | Frankston | |
Australia | Hollywood Private Hospital, Breast Cancer Research Centre | Nedlands | |
Australia | Mater Hospital Brisbane, Mater Cancer Care Centre | South Brisbane | |
Australia | Icon Cancer Centre- Southport | Southport | |
Australia | Sydney Adventist Hospital | Wahroonga | |
Australia | The Queen Elizabeth Hospital | Woodville | |
Austria | University Hospital Graz, Department of Gynecology and Obstetrics | Graz | |
Austria | University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics | Innsbruck | |
Austria | Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I | Linz | |
Austria | Salzburg Regional Hospital, Department of Internal Medicine III | Salzburg | |
Austria | University Hospital St. Poelten, Department of Internal Medicine I | St. Poelten | |
Austria | Hospital Hietzing, Department of Gynecology | Vienna | |
Austria | Medical University Vienna, Department of Gynecology and Obstetrics | Vienna | |
Belgium | Saint Luc University Hospital | Brussels | |
Belgium | Charleroi Grand Hospital (GHDC) | Charleroi | |
Belgium | University Hospital Antwerp (UZA) | Edegem | |
Belgium | AZ Groeninge | Kortrijk | |
Belgium | University Hospitals Leuven, Campus Gasthuisberg | Leuven | |
Belgium | Citadelle Regional Hospital Center | Liège | |
Belgium | VITAZ | Sint-Niklaas | |
Belgium | Centre Hospitalier Peltzer-la-Tourelle | Verviers | |
Belgium | UCL Mont-Godinne University Hospitals | Yvoir | |
Brazil | Oncology Treatment Center | Belém | Pará |
Brazil | Pronutrir | Fortaleza | |
Brazil | ONCOSITE - Clinical Research Center in Oncology | Ijuí | |
Brazil | Juiz de Fora Eurolatino Research Center | Minas Gerais | |
Brazil | Bahia Oncology Center | Salvador de Bahia | |
Brazil | D'OR Institute | São Paulo | |
Brazil | Hospital A.C.Camargo | São Paulo | |
Bulgaria | Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte | Panagyurishte | |
Bulgaria | MHAT for Women's Health "Nadezhda" | Sofia | |
Bulgaria | Multiprofile Hospital for Active Treatment "Serdika", Sofia | Sofia | |
Bulgaria | Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy) | Sofia | |
Bulgaria | University Multiprofile Hospital for Active Treatment "Sveta Marina" | Varna | |
Canada | CIUSSS du Saguenay Lac St-Jean | Chicoutimi | Quebec |
Canada | Hospital Notre-Dame | Montréal | Quebec |
Canada | Maisonneuve-Rosemont Hospital | Montréal | Quebec |
Canada | BC Cancer - Vancouver, Medical Oncology | Vancouver | British Columbia |
Czechia | University Hospital Olomouc, Clinic of Oncology | Olomouc | |
Czechia | Thomayer University Hospital, Clinic of Oncology | Prague | |
Czechia | University Hospital Bulovka, Institute of Radiation Oncology | Prague | |
Czechia | University Hospital Motol, Clinic of Oncology | Prague | |
France | Bergonie Institute | Bordeaux | |
France | Francois Baclesse Center | Caen | |
France | La Roche-sur-Yon Hospital | La Roche-sur-Yon | |
France | CHU La Timone - La Timone Children's Hospital | Marseille | |
France | University Hospital Center of Poitiers | Poitiers | |
France | Saint Anne Clinic | Strasbourg | |
France | Gustave Roussy | Villejuif | |
Germany | Hospital Bayreuth | Bayreuth | |
Germany | Vivantes Hospital Am Urban | Berlin | |
Germany | Private Practice with Focus on Oncology | Luebeck | |
Germany | University Hospital Johannes Gutenberg - University of Mainz | Mainz | |
Germany | Hospital Suedstadt Rostock | Mecklenburg | |
Germany | University Hospital Muenster | Münster | |
Germany | Caritas Klinikum | Saarbrücken | |
Germany | Helios Clinic Wuppertal | Wuppertal | |
Greece | Alexandra General Hospital | Athens | |
Greece | University General Hospital of Ioannina | Ioánnina | |
Greece | IASO Thessaly SA | Larissa | |
Greece | EUROMEDICA General Clinic of Thessaloniki | Thessaloníki | |
Greece | Theageneio Anticancer Hospital of Thessaloniki | Thessaloníki | |
Hungary | University of Debrecen Clinical Center, Institute of Oncology | Debrecen | |
Hungary | Bacs-Kiskun County Hospital, Center for Oncoradiology | Kecskemét | |
Hungary | Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology | Nyíregyháza | |
India | HCG Cancer Centre | Bangalore | |
India | Postgraduate Institute of Medical Education and Research (PGIMER) | Chandigarh | |
India | Tata Medical Center | Kolkata | |
India | Tata Memorial Hospital | Navi Mumbai | |
India | Christian Medical College, Department of Medical Oncology | Vellore | |
Italy | European Institute of Oncology (IEO), IRCCS | Milan | |
Italy | University Polyclinic Hospital of Modena | Modena | |
Italy | Local Healthcare Company of Monza (ASST Monza) | Monza | |
Italy | University Hospital of Parma | Parma | |
Italy | New Hospital of Prato (NOP) | Prato | |
Italy | University Hospital Campus Bio-Medico | Rome | |
Italy | University Polyclinic Foundation "Agostino Gemelli" - IRCCS | Rome | |
Italy | Santa Maria della Misericordia University Hospital of Udine | Udine | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Gangnam Severance Hospital | Soeul | |
Korea, Republic of | Korea University Anam Hospital | Soeul | |
Korea, Republic of | Samsung Medical Center | Soeul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Soeul | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Mexico | Clinical Research Center Chapultepec Mexico City | Mexico City | |
Mexico | CRYPTEX | Mexico City | |
Mexico | ProcliniQ Clinical Research | Mexico City | |
Mexico | Filios High Medicine | Monterrey | |
Mexico | Administrative Society of Health Services, SC | Morelia | |
Mexico | Avix Clinical Research | Nuevo León | |
Mexico | Zambrano Hellion Medical Center | Nuevo León | |
Mexico | Inbiomedyc | Querétaro | |
Mexico | ONCOR Life Medical Center | Saltillo | |
Poland | Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic | Bydgoszcz | |
Poland | Medical Clinic "Komed" | Konin | |
Poland | Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow | Kraków | |
Poland | Polish Mother's Memorial Hospital-Research Institute | Lódz | |
Poland | Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit | Opole | |
Poland | St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre | Siedlce | |
Poland | West Pomeranian Oncology Center | Szczecin | |
Poland | LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy | Warsaw | |
Poland | Maria Sklodowska-Curie - National Research Institute of Oncology | Warsaw | |
Poland | Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy | Wroclaw | |
Romania | S.C. Oncopremium-Team SRL | Baia Mare | |
Romania | Prof. Dr. Alexandru Trestioreanu Institute of Oncology | Bucharest | |
Romania | Prof. Dr. Ion Chiricuta Institute of Oncology | Cluj-Napoca | |
Romania | Onco Clinic Consult S.A. | Craiova | |
Romania | Oncology Center "Sf. Nectarie" | Craiova | |
Romania | S.C. Topmed Medical Center SRL | Târgu-Mures | |
Singapore | Curie Oncology | Singapore | |
Singapore | ICON SOC Farrer Park Medical Clinic | Singapore | |
Singapore | OncoCare Cancer Centre | Singapore | |
Singapore | Raffles Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore | |
Spain | Infanta Cristina Hospital | Badajoz | |
Spain | Catalan Institute of Oncology, Hospital Duran i Reynals | Barcelona | |
Spain | Caceres Hospital Complex - San Pedro de Alcantara General Hospital | Cáceres | |
Spain | Hospital Ruber Internacional | Madrid | |
Spain | University Hospital Foundation Jimenez Diaz | Madrid | |
Spain | University Clinical Hospital Virgen de la Arrixaca, Department of Oncology | Murcia | |
Spain | University Hospital Complex of Santiago (CHUS), Department of Oncology | Santiago De Compostela | |
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
Taiwan | Taipei Medical University - Shuang Ho Hospital | New Taipei City | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United Kingdom | Royal United Hospital, Department of Oncology/Hematology | Bath | |
United Kingdom | Velindre Cancer Centre | Cardiff | |
United Kingdom | Guy's Hospital | London | |
United Kingdom | Royal Marsden Hospital - London, Department of Medical Oncology | London | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United States | New York Oncology Hematology, P.C. - Albany | Albany | New York |
United States | Pacific Cancer Medical Center Inc | Anaheim | California |
United States | Illinois Cancer Specialists - Arlington Heights | Arlington Heights | Illinois |
United States | Texas Oncology - Austin | Austin | Texas |
United States | American Oncology Partners of Maryland, PA | Bethesda | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Consultants In Medical Oncology and Hematology, P.C. | Broomall | Pennsylvania |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | The James Cancer Hospital and Solove Research Institute | Columbus | Ohio |
United States | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | Texas Oncology P.A. - Dallas | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | William Beaumont Army Medical Center | El Paso | Texas |
United States | Fort Belvoir Community Hospital | Fort Belvoir | Virginia |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Arizona Oncology (US Oncology/McKesson) - Goodyear | Goodyear | Arizona |
United States | Cone Health Cancer Center at Alamance Regional, Hematology/Oncology | Greensboro | North Carolina |
United States | Kaiser Permanente South Bay Medical Center | Harbor City | California |
United States | South Broward Hospital District d/b/a Memorial Healthcare System | Hollywood | Florida |
United States | Alliance Cancer Specialists PC | Horsham | Pennsylvania |
United States | Brooke Army Medical Center | Houston | Texas |
United States | Oncology Consultants | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Cancer Specialists of North Florida - Jacksonville | Jacksonville | Florida |
United States | Queens Hospital Cancer Center | Jamaica | New York |
United States | St. Bernards Medical Center | Jonesboro | Arkansas |
United States | University of Kentucky Medical Center | Lexington | Kentucky |
United States | Nebraska Hematology - Oncology, P.C. | Lincoln | Nebraska |
United States | CARTI Cancer Center | Little Rock | Arkansas |
United States | Cancer and Blood Specialty Clinic | Los Alamitos | California |
United States | Southeast Regional Cancer Center | Lumberton | North Carolina |
United States | Texas Oncology - McKinney | McKinney | Texas |
United States | Bon Secours St. Francis Medical Oncology Center | Midlothian | Virginia |
United States | Pacific Cancer Care | Monterey | California |
United States | Yale Cancer Center - New Haven | New Haven | Connecticut |
United States | Coleman, Pasmantier & Decter, MDs | New York | New York |
United States | Weill Cornell Medicine/New York-Presbyterian Hospital | New York | New York |
United States | Virginia Oncology Associates - Newport News | Newport News | Virginia |
United States | OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of California, Irvine Medical Center | Orange | California |
United States | Ventura County Hematology Oncology Specialists | Oxnard | California |
United States | Mercy Health - Paducah | Paducah | Kentucky |
United States | Redlands Hematology Oncology | Redlands | California |
United States | VCU Massey Cancer Center | Richmond | Virginia |
United States | Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Maryland Oncology Hematology, P.A. - Rockville | Rockville | Maryland |
United States | Oregon Oncology Specialists | Salem | Oregon |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | UCLA Hematology/Oncology-Santa Monica | Santa Monica | California |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
United States | Sanford Gynecologic Oncology Clinic | Sioux Falls | South Dakota |
United States | Texas Oncology - Gulf Coast | Sugar Land | Texas |
United States | Hematology/Oncology Associates of Central New York | Syracuse | New York |
United States | Northwest Medical Specialties, PLLC - Tacoma | Tacoma | Washington |
United States | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida |
United States | John D. Archbold Memorial Hospital | Thomasville | Georgia |
United States | Northwest Cancer Specialists, PC - Tigard | Tigard | Oregon |
United States | Torrance Memorial Physician Network - Cancer Care | Torrance | California |
United States | Texas Oncology - Tyler | Tyler | Texas |
United States | Kaiser Permanente Medical Center - Vallejo | Vallejo | California |
United States | White Plains Hospital | White Plains | New York |
United States | PIH Health Hospital Whittier | Whittier | California |
United States | Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A. | Winter Haven | Florida |
United States | Cancer Care Associates of York | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Celcuity, Inc. |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Mexico, Poland, Romania, Singapore, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR) | Approximately 48 months | |
Secondary | Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | OS is defined as the length of time from randomization until the date of death from any cause method, where PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR) | From date of randomization to the date of death due to any cause, up to approximately 48 months | |
Secondary | Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response [CR] or partial response [PR]) as assessed by BICR) | Up to approximately 48 months | |
Secondary | Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first | Up to approximately 48 months | |
Secondary | Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first | Up to approximately 48 months | |
Secondary | Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR | Up to approximately 48 months | |
Secondary | Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | The FACT-B TOI is an abbreviated (24-item) version of the full FACT-B which focuses only on the patient's Physical Well-being (PWB), Functional Well-being (FWB), and Breast Cancer Subscale (BCS) components using a 5-level scale, (Not at all, A little bit, Some-what, Quite a bit, Very much). | From baseline to 30 Day Safety Follow-up | |
Secondary | Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | NCCN-FACT is derived from the FACT-B and only 4 additional items will be administered to enable optional scoring of the NFBSI subscales and total score using a 5-level scale (Not at all, A little bit, Some-what, Quite a bit, Very much). | From baseline to 30 Day Safety Follow-up | |
Secondary | Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 - Physical Function 8c using a 5-level scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do) | From baseline to 30 Day Safety Follow-up | |
Secondary | EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | EuroQol 5 Dimension 5 Level (EQ-5D-5L) - This is a 5 question, self-administered visual analog scale (VAS) where patients use 0 (worst health) to 100 (best health) to indicate how they view their health. | From baseline to 30 Day Safety Follow-up | |
Secondary | Adverse Events | Safety and tolerability will be evaluated by review of type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities | Up to approximately 48 months |
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