Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Recruiting · NCT06757634 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Arm A: Gedatolisib + Palbociclib + FulvestrantArm B: Ribociclib + FulvestrantArm C: Gedatolisib + Palbociclib + LetrozoleArm D: Ribociclib + Letrozole
What this trial is about
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- 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 for the duration of the study.
- Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.
- Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.
- Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
- Permitted prior therapies:
- (neo)adjuvant fulvestrant only if the treatment duration \< 6 months
- (neo)adjuvant chemotherapy
- (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
- i. Study 1: if disease progression was on or within event occurred \>6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment.
- ii. Study 2: if disease progression event occurred \>12 months after completion of CDK4/6 inhibitor portion of treatment.
- Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of at least \>6 months.
- Adequate bone marrow, hepatic, renal and coagulation function.
Exclusion criteria
- Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.
- Prior treatment with systemic anticancer therapy for ABC
- Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.
- Known and untreated, or active, brain or leptomeningeal metastases
- History of clinically significant cardiovascular abnormalities
- Known, clinically significant ophthalmic conditions
- History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis
Where it is running
60 locations listed across 16 US states.
- City of Hope Medical Center - Duarte, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- UCLA Hematology Oncology Santa Monica - Los Angeles, California, United States
- BRCR Medical Center, Inc- Internal Medicine - Plantation, Florida, United States
- BRCR Medical Center, INC - Tamarac, Florida, United States
- The University of Kansas Cancer Center - Westwood, Kansas, United States
- Mercy Health-Paducah Cancer Center - Paducah, Kentucky, United States
- American Oncology Partners, P.A. - Bethesda, Maryland, United States
- Massachusetts General Hospital Cancer Center - Boston, Massachusetts, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Saint Luke's Cancer Institute - Kansas City, Missouri, United States
- Washington University School of Medicine in Saint Louis - St Louis, Missouri, United States
- SCL Health - Cancer Centers of Montana - Billings, Montana, United States
- Weill Cornell Medical College - NewYork-Presbyterian Hospital - New York, New York, United States
- Clinical Research Alliance, Inc. - Westbury, New York, United States
- Stefanie Spielman Comprehensive Breast Center at Olentangy River Road - Columbus, Ohio, United States
- Rittenhouse Hematology/Oncology - Philadelphia, Pennsylvania, United States
- Sanford Health - Sioux Falls, South Dakota, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Mays Cancer Center - San Antonio, Texas, United States
- Bon Secours St. Francis Medical Oncology Center - Midlothian, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Complexo Hospitalario Universitario A Coruña - A Coruña, Spain
- Adana Baskent Practice and Research Hospital - Oncology - Adana, Turkey (Türkiye)
- GenesisCare - St Andrews - Adelaide, Australia
- San Peregrino Unidad de Investigacion - Aguascalientes, Mexico
- Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo - Amiens, France
- Gulhane Training and Research Hospital - Medical Oncology - Ankara, Turkey (Türkiye)
- Hacettepe University Medical Faculty - Hematology - Ankara, Turkey (Türkiye)
- Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi - Ankara, Turkey (Türkiye)
- Ankara University Medical Faculty - Oncology - Ankara, Turkey (Türkiye)
- Areteio Hospital - Athens, Greece
- Hospital Universitario de Badajoz - Badajoz, Spain
- Centrul de Oncologie Sf Nectarie - Medical Oncology - Baia Mare, Romania
- Oncopremium Team - Medical Oncology - Baia Mare, Romania
- King Chulalongkorn Memorial Hospital [Medical Oncology] - Bangkok, Thailand
- Rajavithi Hospital - Bangkok, Thailand
- Siriraj Hospital - Medical Oncology - Bangkok, Thailand
- Hospital Del Mar - Barcelona, Spain
- Hospital Clinic De Barcelona - Barcelona, Spain
- Oncocentro Belo Horizonte - Belo Horizonte, Brazil
- CTO Centro de Tratamento Oncológico - Belém, Brazil
- Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni - Brno, Czechia
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Bucharest, Romania
- Centro de Oncologia e Investigacion Buenos Aires COIBA - Buenos Aires, Argentina
- Pergamino Clinic - Buenos Aires, Argentina
- CENIT Foundation - Buenos Aires, Argentina
- Fleischer Medical Center (Centro Medico Fleischer) - Buenos Aires, Argentina
- Fundacion Respirar - Buenos Aires, Argentina
- Centro Oncológico Korben - Buenos Aires, Argentina
- Alexander Fleming Institute - Buenos Aires, Argentina
- Center for Medical Education and Clinical Research (CEMIC) - Buenos Aires, Argentina
- Complex Oncology Center - Burgas - Burgas, Bulgaria
- Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii - Bydgoszcz, Poland
- Centre Georges François Baclesse - Caen, France
- Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology - Changhua, Taiwan
- Grand Hopital De Charleroi - Charleroi, Belgium
- Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Cluj-Napoca, Romania
Showing 60 of 203 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →