A Study to Learn About the Study Medicine Called PF-07248144 in Combination with Fulvestrant in People with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer who Progressed After a Prior Line of Treatment
Treatment
Phase 3 study for adults with advanced/metastatic HR-positive, HER2-negative breast cancer who have progressed from prior treatment
Clinicaltrials.gov identifier:NCT07062965
Study Contact Information:
Please visit www.katsis1study.com for more information.
About the Study
KATSIS-1 is a clinical trial exploring an investigational medicine called prifetrastat.
Over time, breast cancer cells can learn how to avoid standard hormone treatments and continue growing. Think of the cancer like a machine that has found a hidden workaround to keep running. Prifetrastat is designed to block that workaround and "rewire" the cells, making the cancer weak to standard hormone therapies once again.
KATSIS-1 clinical trial participants will be randomly assigned, like a coin-flip, to one of two treatment groups. Throughout the trial, a dedicated medical team closely monitors their health and progress through regular clinic visits and scans.
This Study is Open To:
People may be eligible to join the KATSIS-1 study if they are 18 or older and have been diagnosed with , advanced or breast cancer, which has spread elsewhere in the body after prior treatment with a CDK4/6 inhibitor or have received one additional systemic treatment before or after treatment with a CDK4/6 inhibitor.
This Study is NOT Open To:
Individuals may not be eligible if they have serious medical or psychiatric conditions, active infections, significant heart or brain disease, or abnormal kidney, liver, or blood test results. Exclusion may also apply to those with specific tumour gene alterations, extensive or rapidly progressing disease, no prior chemotherapy or targeted therapies for advanced disease, more than two prior systemic treatments, recent major surgery, or recent participation in another clinical trial.
What the Study Involves
- KATSIS-1 is a , Phase 3 clinical trial. Participants are randomly assigned to receive either the study treatment (prifetrastat) with fulvestrant or the study doctor’s choice of currently approved treatment (either exemestane or fulvestrant) plus another approved medicine called everolimus.
- Interested patients will complete screening tests to confirm eligibility, including medical history reviews, blood tests, physical exam, heart activity tests, and scans to measure tumors.
- You will also be asked to participate in testing to confirm your eligibility.
To determine if you may be eligible for the KATSIS1 clinical trial, the study team will send your tumor sample for () tests. These tests identify specific features of your breast cancer and help the study team understand how it may respond to the study treatment. The testing process, including shipping the tissue and carefully checking the results, usually takes about two to four weeks. Your tissue will only be tested if you give your permission.
- Participants receive one of the two study treatments. Regular clinic visits are important for monitoring while you are on study treatment, including blood tests, scans to monitor tumor size and health assessments. Additional procedures, such as biopsies, may be needed.
Study participation also includes follow-up visits and brief assessments on how you are doing after you decide to stop study treatment. Additional commitment may be required, but the study team will discuss this further with you.
Participants may receive reimbursement for treatment-related costs, such as travel.
Study Contact Information:
Please visit www.katsis1study.com for more information.
Locations:
Arizona
City: Chandler RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Gilbert RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Glendale RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Goodyear RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Mesa RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Mesa RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Phoenix RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
City: Scottsdale RECRUITING
Facility: Ironwood Cancer & Research Centers
Contact Info:
No contact info provided
Connecticut
City: Derby RECRUITING
Facility: Smilow Cancer Hospital - Derby
Contact Info:
No contact info provided
City: Fairfield RECRUITING
Facility: Smilow Cancer Hospital - Fairfield
Contact Info:
No contact info provided
City: Glastonbury RECRUITING
Facility: Smilow Cancer Hospital - Glastonbury
Contact Info:
No contact info provided
City: Greenwich RECRUITING
Facility: Smilow Cancer Hospital - Greenwich
Contact Info:
No contact info provided
City: Guilford RECRUITING
Facility: Smilow Cancer Hospital - Guilford
Contact Info:
No contact info provided
City: Hartford RECRUITING
Facility: Smilow Cancer Hospital at Saint Francis
Contact Info:
No contact info provided
City: New Haven RECRUITING
Facility: Smilow Cancer Hospital - Yale New Haven Health
Contact Info:
No contact info provided
City: North Haven RECRUITING
Facility: Smilow Cancer Hospital - North Haven
Contact Info:
No contact info provided
City: Stamford RECRUITING
Facility: Smilow Cancer Hospital - Long Ridge
Contact Info:
No contact info provided
City: Waterbury RECRUITING
Facility: Smilow Cancer Hospital - Waterbury
Contact Info:
No contact info provided
Georgia
City: Atlanta RECRUITING
Facility: Emory University Hospital Midtown
Contact Info:
No contact info provided
City: Savannah RECRUITING
Facility: Summit Cancer Care, PC
Contact Info:
No contact info provided
City: Savannah RECRUITING
Facility: Summit Cancer Care
Contact Info:
No contact info provided
Illinois
City: Shiloh RECRUITING
Facility: Memorial Hospital.
Contact Info:
No contact info provided
Michigan
City: Holland RECRUITING
Facility: The Cancer & Hematology Centers
Contact Info:
No contact info provided
Missouri
City: City of Saint Peters RECRUITING
Facility: Siteman Cancer Center - St Peters
Contact Info:
No contact info provided
City: Florissant RECRUITING
Facility: Siteman Cancer Center - North County
Contact Info:
No contact info provided
City: St Louis RECRUITING
Facility: Siteman Cancer Center
Contact Info:
No contact info provided
Tennessee
City: Nashville RECRUITING
Facility: SCRI Oncology Partners
Contact Info:
No contact info provided
City: Nashville RECRUITING
Facility: Henry-Joyce Cancer Clinic
Contact Info:
No contact info provided
Texas
City: Allen RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Austin RECRUITING
Facility: Texas Oncology - Central South (Balcones Dr)
Contact Info:
No contact info provided
City: Austin RECRUITING
Facility: Texas Oncology - Central South (James Casey)
Contact Info:
No contact info provided
City: Denison RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Denton RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Flower Mound RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Houston RECRUITING
Facility: University of Texas MD Anderson Cancer Center
Contact Info:
No contact info provided
City: Houston RECRUITING
Facility: MD Anderson West Houston
Contact Info:
No contact info provided
City: Irving RECRUITING
Facility: US Oncology Investigational Product Center (IPC)
Contact Info:
No contact info provided
City: Irving RECRUITING
Facility: US Oncology Investigational Products Center
Contact Info:
No contact info provided
City: League City RECRUITING
Facility: MD Anderson League City
Contact Info:
No contact info provided
City: Lewisville RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Longview RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: McAllen RECRUITING
Facility: Texas Oncology - Central South (South 2nd)
Contact Info:
No contact info provided
City: McKinney RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Palestine RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Paris RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
City: Tyler RECRUITING
Facility: Texas Oncology-Northeast Texas
Contact Info:
No contact info provided
Utah
City: Salt Lake City RECRUITING
Facility: Huntsman Cancer Institute
Contact Info:
No contact info provided
Virginia
City: Mechanicsville RECRUITING
Facility: Bon Secours Cancer Institute at Memorial Regional Medical Center
Contact Info:
No contact info provided
Other Countries
Country: Australia
State: Victoria
City: Melbourne RECRUITING
Facility: Peter MacCallum Cancer Centre
Contact Info:
No contact info provided
Country: Australia
State: Victoria
City: St Albans RECRUITING
Facility: Western Health-Sunshine & Footscray Hospitals
Contact Info:
No contact info provided
Country: Belgium
State: Antwerpen
City: Brasschaat RECRUITING
Facility: Algemeen Ziekenhuis klina
Contact Info:
No contact info provided
Country: Belgium
State: Bruxelles-capitale, Région de
City: Anderlecht RECRUITING
Facility: Institut Jules Bordet
Contact Info:
No contact info provided
Country: Belgium
State: West-vlaanderen
City: Kortrijk RECRUITING
Facility: AZ Groeninge Campus Kennedylaan
Contact Info:
No contact info provided
Country: Brazil
State: Espírito Santo
City: Vitória RECRUITING
Facility: Afecc Associacao Feminina Educacao Combate Cancer
Contact Info:
No contact info provided
Country: Brazil
State: Rio Grande do Sul
City: Ijuí RECRUITING
Facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Contact Info:
No contact info provided
Country: Brazil
State: Santa Catarina
City: Lages RECRUITING
Facility: ANIMI - Unidade de Tratamento Oncologico
Contact Info:
No contact info provided
Country: Bulgaria
City: Haskovo RECRUITING
Facility: Specialized Hospital for Active Treatment of Oncology - Haskovo
Contact Info:
No contact info provided
Country: Bulgaria
City: Shumen RECRUITING
Facility: Complex Oncology Center - Shumen
Contact Info:
No contact info provided
Country: Bulgaria
State: Sofia (stolitsa)
City: Sofia RECRUITING
Facility: Multiprofile Hospital for Active Treatment Serdikamed EOOD
Contact Info:
No contact info provided
Country: Canada
City: Québec RECRUITING
Facility: CHU de Québec-Université Laval
Contact Info:
No contact info provided
Country: Canada
State: Quebec
City: Québec RECRUITING
Facility: CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Contact Info:
No contact info provided
Country: China
State: Anhui
City: Hefei RECRUITING
Facility: Anhui Provincial Cancer Hospital
Contact Info:
No contact info provided
Country: China
State: Fujian
City: Fuzhou RECRUITING
Facility: Fujian Medical University Union Hospital
Contact Info:
No contact info provided
Country: China
State: Guangdong
City: Guangzhou RECRUITING
Facility: Sun Yat-sen University Cancer Center
Contact Info:
No contact info provided
Country: China
State: Guangdong
City: Guangzhou RECRUITING
Facility: Southern Medical University Nanfang Hospital
Contact Info:
No contact info provided
Country: China
State: Hubei
City: Wuhan RECRUITING
Facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Contact Info:
No contact info provided
Country: China
State: Jiangsu
City: Nanjing RECRUITING
Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Contact Info:
No contact info provided
Country: China
State: Liaoning
City: Dalian RECRUITING
Facility: The 2nd Affiliated Hospital of Dalian Medical University
Contact Info:
No contact info provided
Country: China
State: Shandong
City: Jinan RECRUITING
Facility: Shandong Cancer Hospital
Contact Info:
No contact info provided
Country: China
State: Shanghai Municipality
City: Shanghai RECRUITING
Facility: Fudan University Shanghai Cancer Center
Contact Info:
No contact info provided
Country: Czechia
City: Nový Jičín RECRUITING
Facility: Nemocnice AGEL Novy Jicin a.s.
Contact Info:
No contact info provided
Country: Czechia
State: Praha 4
City: Prague RECRUITING
Facility: Fakultni Thomayerova nemocnice
Contact Info:
No contact info provided
Country: Czechia
State: Praha 5
City: Prague RECRUITING
Facility: Fakultni nemocnice v Motole
Contact Info:
No contact info provided
Country: Finland
State: Northern Savonia
City: Kuopio RECRUITING
Facility: Kuopion Yliopistollinen Sairaala
Contact Info:
No contact info provided
Country: Finland
State: Pirkanmaa
City: Tampere RECRUITING
Facility: Tampereen yliopistollinen sairaala
Contact Info:
No contact info provided
Country: Finland
State: Uusimaa
City: Helsinki RECRUITING
Facility: Docrates Syöpäsairaala
Contact Info:
No contact info provided
Country: Germany
City: Berlin RECRUITING
Facility: Charité Universitaetsmedizin Berlin - Campus Mitte
Contact Info:
No contact info provided
Country: Germany
State: Bavaria
City: Erlangen RECRUITING
Facility: Universitaetsklinikum Erlangen
Contact Info:
No contact info provided
Country: Greece
State: Attica
City: Athens RECRUITING
Facility: IASO General Clinic
Contact Info:
No contact info provided
Country: Greece
State: Attikí
City: Marousi RECRUITING
Facility: Hygeia Hospital
Contact Info:
No contact info provided
Country: Greece
State: Irakleío
City: Heraklion RECRUITING
Facility: University General Hospital of Heraklion
Contact Info:
No contact info provided
Country: India
State: Gujarat
City: Surat RECRUITING
Facility: Nirmal Hospital Pvt Ltd.
Contact Info:
No contact info provided
Country: India
State: Karnataka
City: Bengaluru RECRUITING
Facility: Spandana Oncology Centre (SOC)
Contact Info:
No contact info provided
Country: Israel
State: Central District
City: Petah Tikva RECRUITING
Facility: Rabin Medical Center
Contact Info:
No contact info provided
Country: Israel
State: Jerusalem
City: Jerusalem RECRUITING
Facility: Shaare Zedek Medical Center
Contact Info:
No contact info provided
Country: Israel
State: Jerusalem
City: Jerusalem RECRUITING
Facility: Hadassah Medical Center
Contact Info:
No contact info provided
Country: Israel
State: Northern District
City: Haifa RECRUITING
Facility: Rambam Health Care Campus
Contact Info:
No contact info provided
Country: Italy
State: Emilia-Romagna
City: Bologna RECRUITING
Facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Contact Info:
No contact info provided
Country: Italy
State: Emilia-Romagna
City: Meldola RECRUITING
Facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Contact Info:
No contact info provided
Country: Japan
City: Fukuoka RECRUITING
Facility: National Hospital Organization Kyushu Cancer Center
Contact Info:
No contact info provided
Country: Japan
City: Tokyo RECRUITING
Facility: Showa Medical University Hospital
Contact Info:
No contact info provided
Country: Japan
State: Chiba
City: Kashiwa RECRUITING
Facility: National Cancer Center Hospital East
Contact Info:
No contact info provided
Country: Japan
State: Gunma
City: Otashi RECRUITING
Facility: Gunma Prefectural Cancer Center
Contact Info:
No contact info provided
Country: Japan
State: Kanagawa
City: Isehara RECRUITING
Facility: Tokai University Hospital
Contact Info:
No contact info provided
Country: Japan
State: Kanagawa
City: Yokohama RECRUITING
Facility: Kanagawa cancer center
Contact Info:
No contact info provided
Country: Japan
State: Tokyo
City: Bunkyo-ku RECRUITING
Facility: Juntendo University Hospital
Contact Info:
No contact info provided
Country: Mexico
City: Mexico City RECRUITING
Facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.
Contact Info:
No contact info provided
Country: Mexico
State: Oaxaca
City: Oaxaca City RECRUITING
Facility: Centro de Investigacion Clinica de Oaxaca
Contact Info:
No contact info provided
Country: Netherlands
State: South Holland
City: Schiedam RECRUITING
Facility: Franciscus Vlietland Ziekenhuis
Contact Info:
No contact info provided
Country: Slovakia
City: Bratislava RECRUITING
Facility: Narodny onkologicky ustav
Contact Info:
No contact info provided
Country: Slovakia
State: Bratislava Region
City: Bratislava RECRUITING
Facility: Onkologicky Ustav sv. Alzbety
Contact Info:
No contact info provided
Country: Slovakia
State: Košice Region
City: Košice RECRUITING
Facility: Vychodoslovensky Onkologicky ustav a.s.
Contact Info:
No contact info provided
Country: South Korea
State: Kyǒnggi-do
City: Seongnam-si RECRUITING
Facility: Seoul National University Bundang Hospital
Contact Info:
No contact info provided
Country: South Korea
State: Seoul-teukbyeolsi [seoul]
City: Gangnam-gu RECRUITING
Facility: Gangnam Severance Hospital, Yonsei University Health System
Contact Info:
No contact info provided
Country: South Korea
State: Seoul-teukbyeolsi [seoul]
City: Seoul RECRUITING
Facility: Severance Hospital, Yonsei University Health System
Contact Info:
No contact info provided
Country: South Korea
State: Seoul-teukbyeolsi [seoul]
City: Seoul RECRUITING
Facility: Samsung Medical Center
Contact Info:
No contact info provided
Country: Spain
City: Granada RECRUITING
Facility: Hospital Universitario San Cecilio
Contact Info:
No contact info provided
Country: Spain
City: Jaén RECRUITING
Facility: Hospital Universitario de Jaen
Contact Info:
No contact info provided
Country: Spain
City: Zaragoza RECRUITING
Facility: Hospital Universitario Miguel Servet
Contact Info:
No contact info provided
Country: Spain
State: A Coruña [LA Coruña]
City: A Coruña RECRUITING
Facility: CHUAC-Complejo Hospitalario Universitario A Coruña
Contact Info:
No contact info provided
Country: Spain
State: Barcelona [barcelona]
City: Barcelona RECRUITING
Facility: Hospital Universitari Vall d'Hebron
Contact Info:
No contact info provided
Country: Spain
State: Basque Country
City: Bilbao RECRUITING
Facility: Osi Bilbao-Basurto
Contact Info:
No contact info provided
Country: Spain
State: Catalunya [cataluña]
City: Barcelona RECRUITING
Facility: Hospital Clínic de Barcelona
Contact Info:
No contact info provided
Country: Spain
State: Málaga
City: Málaga RECRUITING
Facility: Hospital Universitario Virgen de la Victoria
Contact Info:
No contact info provided
Country: Sweden
City: Gothenburg RECRUITING
Facility: Sahlgrenska Universitetssjukhuset
Contact Info:
No contact info provided
Country: Sweden
State: Stockholms LÄN [se-01]
City: Stockholm RECRUITING
Facility: Södersjukhuset
Contact Info:
No contact info provided
Country: Taiwan
City: Taipei RECRUITING
Facility: Taipei Veterans General Hospital
Contact Info:
No contact info provided
Country: Taiwan
State: Tainan
City: Tainan RECRUITING
Facility: Chi Mei Medical Center
Contact Info:
No contact info provided
Country: Turkey (Türkiye)
City: Ankara RECRUITING
Facility: Memorial Ankara Hastanesi
Contact Info:
No contact info provided
Country: Turkey (Türkiye)
City: Ankara RECRUITING
Facility: Ankara Bilkent Şehir Hastanesi
Contact Info:
No contact info provided
Country: Turkey (Türkiye)
City: Diyarbakır RECRUITING
Facility: Dicle Üniversitesi
Contact Info:
No contact info provided
Country: Turkey (Türkiye)
State: İ̇stanbul
City: Istanbul RECRUITING
Facility: Medipol Mega Universite Hastanesi
Contact Info:
No contact info provided
Treatment
Phase 3 study for adults with advanced/metastatic HR-positive, HER2-negative breast cancer who have progressed from prior treatment
Clinicaltrials.gov identifier:NCT07062965
Study Contact Information:
Please visit www.katsis1study.com for more information.