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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05501886
Other study ID # CELC-G-301
Secondary ID 2021-005235-24
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 30, 2022
Est. completion date September 30, 2026

Study information

Verified date July 2023
Source Celcuity, Inc.
Contact Nadene Zack, MS
Phone 844-310-3900
Email VIKTORIA-1_TRIAL@CELCUITY.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Palbociclib
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Fulvestrant
Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1
Alpelisib
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Celcuity, Inc.

Countries where clinical trial is conducted

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, 

Outcome

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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