Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official Title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Study ID: NCT03800836
Conditions
Study Description
Brief Summary: This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Shores Medical Group, Long Beach, California, United States
St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept, Darlinghurst, New South Wales, Australia
Peter MacCallum Cancer Center, East Melbourne, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Institut de Cancerologie de l Ouest, Angers, , France
Institut Bergonie, Bordeaux, , France
Centre Georges Francois Leclerc, Dijon, , France
Institut Curie, Paris, , France
Gustave Roussy, Villejuif CEDEX, , France
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz., Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Barts Cancer Institute, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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