Breast Cancer Clinical Trial
A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.
This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
This study will evaluate the efficacy, safety and pharmacokinetics of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) previously untreated in this setting. Participants with Programmed Death-Ligand 1 (PD-L1) non-positive and PD-L1 positive tumors will be independently enrolled in Cohorts 1 and 2, respectively. The combination of ipatasertib, atezolizumab and paclitaxel will be evaluated in Cohorts 1 and 2 and the combination of ipatasertib and paclitaxel will be evaluated in Cohort 1.
Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator's judgement.
Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
Life expectancy of at least 6 months.
Measurable disease according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
Appropriate candidate for paclitaxel monotherapy if tumor PD-L1 status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.
Inability to comply with study and follow-up procedures.
History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
Known HIV infection (there must be a negative HIV test at screening).
Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
Current treatment with anti-viral therapy for HBV.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib/placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction < 50%, or active ventricular arrhythmia requiring medication.
Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) > 480 ms.
Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications.
History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
Known CNS disease, except for treated asymptomatic CNS metastases.
Known germline BRCA1/2 deleterious mutation, unless the participant is not an appropriate candidate for a PARP-inhibitor.
Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
Uncontrolled pleural effusion, pericardial effusion or ascites.
Uncontrolled tumor-related pain.
Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
Grade >= 2 peripheral neuropathy.
History of Type I or Type II diabetes mellitus requiring insulin.
Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
Prior treatment with an Akt inhibitor.
Active or history of autoimmune disease or immune deficiency.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Prior allogeneic stem cell or solid organ transplantation.
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the final dose of atezolizumab.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study.
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There are 177 Locations for this study
Mobile Alabama, 36688, United States
Springdale Arkansas, 72762, United States
Los Angeles California, 90095, United States
San Diego California, 92108, United States
Stanford California, 94305, United States
Denver Colorado, 80205, United States
Stamford Connecticut, 06904, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Pembroke Pines Florida, 33028, United States
Atlanta Georgia, 30322, United States
Savannah Georgia, 31405, United States
Chicago Illinois, 60612, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21237, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48202, United States
Jackson Mississippi, 39202, United States
Grand Island Nebraska, 68803, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Winston-Salem North Carolina, 27157, United States
Portland Oregon, 97227, United States
Portland Oregon, 97229, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29605, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Buenos Aires , C1125, Argentina
Buenos Aires , C1417, Argentina
Ciudad Autonoma Bs As , C1280, Argentina
Cordoba , X5800, Argentina
La Rioja , F5300, Argentina
Mendoza , M5500, Argentina
Macquarie Park New South Wales, 2109, Australia
Port Macquarie New South Wales, 2444, Australia
St Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Woolloongabba Queensland, 4102, Australia
Kurralta Park South Australia, 5037, Australia
Clayton Victoria, 3168, Australia
Melbourne Victoria, 3000, Australia
St Albans Victoria, , Australia
Subiaco Western Australia, 6008, Australia
Innsbruck , 6020, Austria
Linz , 4010, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Salvador BA, 41253, Brazil
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 04014, Brazil
Sofia , 1330, Bulgaria
Edmonton Alberta, T6G 1, Canada
Surrey British Columbia, V3V 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Barrie Ontario, L4M 6, Canada
Ottawa Ontario, K2H 6, Canada
Montreal Quebec, H4A 3, Canada
Montréal Quebec, H3T 1, Canada
Quebec City Quebec, G1S 4, Canada
Bogota , 11001, Colombia
Pereira , 60000, Colombia
San José , 10103, Costa Rica
Brno , 656 5, Czechia
Olomouc , 779 0, Czechia
Herlev , 2730, Denmark
Odense C , 5000, Denmark
Helsinki , 00180, Finland
Kuopio , 70210, Finland
Vaasa , 65130, Finland
Rennes , 35042, France
Kifisia , 145 6, Greece
Thessaloniki , 546 4, Greece
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Pune Maharashtra, 41102, India
Jerusalem , 91031, Israel
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Brescia Lombardia, 25123, Italy
Lecco Lombardia, 23900, Italy
Rozzano Lombardia, 20089, Italy
Livorno Toscana, 57100, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Fukushima , 960-1, Japan
Gunma , 373-8, Japan
Hiroshima , 734-8, Japan
Kanagawa , 241-8, Japan
Kumamoto , 862-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 135-7, Korea, Republic of
La Paz BAJA California SUR, 23040, Mexico
Cdmx Mexico CITY (federal District), 03100, Mexico
Monterrey Nuevo LEON, 64570, Mexico
Auckland , 1023, New Zealand
Tauranga , 3112, New Zealand
Wellington , 6021, New Zealand
Arequipa , 04001, Peru
Arequipa , 04002, Peru
Lima , 07016, Peru
Lima , 15088, Peru
Lima , 1, Peru
Lima , 41, Peru
Lima , Lima , Peru
San Isidro , Lima , Peru
Gliwice , 44-10, Poland
Kraków , 30-68, Poland
Poznan , 61-86, Poland
Warszawa , 02-78, Poland
Łódź , 93-33, Poland
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Loures , 2674-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Craiova , 20034, Romania
Arkhangelsk Arhangelsk, 16304, Russian Federation
Moscow Moskovskaja Oblast, 12146, Russian Federation
Moskva Moskovskaja Oblast, 11112, Russian Federation
Moskva Moskovskaja Oblast, 11547, Russian Federation
Moskva Moskovskaja Oblast, 12536, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 12528, Russian Federation
Novosibirsk , 63000, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Singapore , 16961, Singapore
Bloemfontein , 9301, South Africa
George , 6529, South Africa
Johannesberg , 2013, South Africa
Port Elizabeth , 6045, South Africa
Pretoria , 0001, South Africa
Castellon de La Plana Castellon, 12002, Spain
A Coruña LA Coruña, 15006, Spain
Majadahonda Madrid, 28222, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
Basel , 4031, Switzerland
Zürich , 8091, Switzerland
Taichung , 404, Taiwan
Taipei , 00112, Taiwan
Taipei , 100, Taiwan
Taoyuan City , 333, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Chiang Mai , 50200, Thailand
Khonkaen , 40000, Thailand
Songkhla , 90110, Thailand
Ankara , 06520, Turkey
Istanbul , 34214, Turkey
Sihhiye/Ankara , 06230, Turkey
Kharkiv Kharkiv Governorate, 61018, Ukraine
Chernigiv , 14029, Ukraine
Dnipropetrovsk , 49102, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 04107, Ukraine
Odesa , 65025, Ukraine
Sumy , 40005, Ukraine
Glasgow , G12 0, United Kingdom
London , SW3 6, United Kingdom
Nottingham , NG7 2, United Kingdom
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