7 results
- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…
Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.1 between treatment armsKey Secondary* Compare overall survival (OS) between treatment arms* Compare PFS by…
To evaluate safety and feasibility of neoadjuvant chemotherapy-free regimen with trastuzumab, pertuzumab and tucatinib in stage II-III HER2-positive breast cancer.
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, and pertuzumab.