Breast cancer represents a significant challenge, and advancing treatment options is crucial for patients facing this disease. VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer.

This trial explores the potential of gedatolisib, given intravenously, to inhibit the PI3K/mTOR pathway, which is known to regulate cell growth and function. By participating in VIKTORIA-1, patients have the opportunity to contribute to groundbreaking research that seeks to offer more effective treatments for breast cancer. Join researchers in advancing breast cancer treatment.

• Participants will be part of advanced breast cancer research.
• Participants will have access to a new investigational treatment.
• Participants will contribute to the development of potential future therapies.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Adults aged 18 years and above who are diagnosed with metastatic or locally advanced breast cancer
• Must meet one of the following criteria:
  • Women who are postmenopausal and have a negative pregnancy test, if able to bear children
  • Pre/perimenopausal women with medically induced menopause and have a negative pregnancy test, if able to bear children
  • Men who use an effective contraceptive method
• Must not have had malignancies other than adequately treated non-melanoma skin cancer or solid tumors treated with no evidence of disease for more than 3 years
• Must be able to swallow oral medication tablets/capsules
• Must not have been treated with any of the following medications: phosphoinositide 3 kinase (PI3K) inhibitor, protein kinase B (Akt) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, chemotherapy and antibody-drug conjugates (e.g. Enhertu®) or more than 2 lines of prior endocrine therapy treatment
• Must have had prior therapy with a CDK4/6 inhibitor (such as palbociclib or ribociclib) in combination with a non-steroidal aromatase inhibitor (such as letrozole or anastrozole)
• Must not have type 1 diabetes or uncontrolled type 2 diabetes
• Must not have been diagnosed with a gastrointestinal tract disease resulting in an inability to absorb oral medication
• Must not have any known hypersensitivity to the study drugs or their components
• Must be able to attend study visits at the research site

The study team will explain the research study in its entirety but some details are:

• Participants will be required to have several tests and procedures conducted such as genetic tests to determine if their cancer has a genetic component (PIK3CA), collection of a biopsy, and CT, ultrasound or mammography scans
• After PIK3CA status is determined, and participants are deemed to qualify to receive treatment, they will be placed in the study
• Participants will receive one of the following medications or a combination thereof: gedatolisib, palbociclib, fulvestrant and/or alpelisib
  • The medications used are intended to decrease the growth and survival of participants’ cancer cells

This research study is taking place in several locations. To see if there is a research site near you, please see below.

Research Site: American Oncology Partners, PA
Location: 6410 Rockledge Drive #660, Bethesda MD 20817
Lead Researcher: Mark Goldstein, MD

Research Site: Redlands Hematology Oncology (Redlands, CA)
Location: 245 Terracina Blvd. Suite 208 Redlands, CA 92373
Lead Researcher: Dr. Emad Ibrahim

Research Site: South Broward Hospital District d/b/a Memorial Healthcare System
Location: Breast Cancer Center, Medical Office Centre, 1150 N. 35th Ave., Suite 170, 1st Floor, Hollywood, FL 33021
Lead Researcher: Delia Guaqueta, MD

This study has been reviewed and approved by the Advarra Institutional Review Board.