USO 21455
A Phase Iii,Randomized, Open-Label Study Evaluating The Efficacy And Safety Of Giredestrant In Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo+Taxane In Patients With Previously Untreated Her2-Positive, Estrogen Receptor-Positive Locally-Advanced Or Metastatic Breast Cancer (Wo43571)
Disease Types: Breast Cancer Research
Eligibility Requirements:
-Must have locally advanced or metastatic ER+/HER2+ adenocarcinoma of the breast not amenable to curative resection
-Must have been disease free ≥ 6 months from completion of non-hormonal neoadjuvant or adjuvant systemic anti-cancer treatment with measurable and/or non-measurable disease that can be evaluated according to RECIS 1.1
-Pre or perimenopausal females and males must be able/willing to maintain treatment with lutenizing hormone-releasing hormone agonist (LHRHa) therapy or if female and not able to tolerate LHRHa therapy willing to undergo bilateral oophorectomy
-No: previous systemic non-hormonal treatment in the metastatic or advanced setting; prior treatment with selective estrogen receptor degrader (fulvestrant, etc.); disease progression within 6 months of receiving trastuzumab with or without pertuzumab or ado-trastuzumab emtansine in adjuvant setting; history of persistent grade ≥ 2 hematological toxicity from previous neoadjuvant or adjuvant anti-cancer treatment; active uncontrolled or symptomatic central nervous system (CNS) metastasis, carcinomatous meningitis, or leptomeningeal disease; dyspnea at rest due to malignant disease complications or other disease requiring continuous oxygen therapy; treated with palliative radiation within 14 days prior to start of treatment; current chronic daily treatment with corticosteroids (10 mg/day or more of methylprednisolone or equivalent, excludes inhaled steroids); poorly controlled hypertension; known clinically significant history of or active liver disease; active cardiac disease or history of cardiac dysfunction; active inflammatory bowel disease, chronic diarrhea, short bowel syndrome or major upper gastrointestinal surgery including gastric resection potentially affecting GI absorption; major surgical procedure or injury with 14 days prior to enrollment or anticipation of need for major surgery during induction therapy; concurrent, serious, uncontrolled infection or known HIV infection (HIV positive patients on stable anti-retroviral therapy with CD4 count ≥ 200 with undetectable viral load and no AIDs-defining opportunistic infection with the last 12 months are eligible); serious infection requiring oral or IV antibiotics within 7 days prior to screening.
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