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New treatment option for Breast Cancer
Official title Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
ClinicalTrials.gov ID: NCT06757634
What this study is testing
What is Arm A: Gedatolisib + Palbociclib + Fulvestrant?
Arm A: Gedatolisib + Palbociclib + Fulvestrant is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as PF-05212384, IBRANCE, Faslodex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Negative pregnancy test for females of childbearing potential. Female people who are not surgically sterile must use a medically effective...
- Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of...
- Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
You likely can't join if
- Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no...
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR)...
- Prior treatment with systemic anticancer therapy for ABC
- people 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
See the full eligibility 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...
- Negative pregnancy test for females of childbearing potential. Female people who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study...
- 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...
- 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...
- 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.
- 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...
- 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)...
- Prior treatment with systemic anticancer therapy for ABC
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Westwood, Kansas, United States
- Paducah, Kentucky, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Billings, Montana, United States
- New York, New York, United States
- Westbury, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
+ 134 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Fullerton, California, United States; Los Angeles, California, United States; Plantation, Florida, United States; Tamarac, Florida, United States; Westwood, Kansas, United States and 148 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.