Comment from The Geneva Foundation , HHS-OPHS-2018-0021, HHS-OPHS-2018-0021-0001, N/A
The Geneva FoundationOtherIndividual
Summary: The commenter is submitting a Participant Information and Informed Consent Form for a Phase 3 clinical trial regarding a new drug for breast cancer. This submission appears to be a procedural filing of a study document rather than a comment expressing a position on the proposed federal action.
A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2 Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) Brooke Army Medical Center/Gilbert Ancira, M.D.; William Beaumont Army Medical Center/Warren Alexander, M.D.