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A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.

Primary Purpose

Triple-Negative Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Ipatasertib
Paclitaxel
Placebo for Atezolizumab
Placebo for Ipatasertib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-Negative Breast Cancer focused on measuring Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Paclitaxel, Atezolizumab, Ipatasertib, Antibodies, Monoclonal, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator's judgement.
  2. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
  3. Life expectancy of at least 6 months.
  4. Measurable disease according to RECIST v1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
  7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
  8. 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.
  9. Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.

Exclusion Criteria:

  1. Inability to comply with study and follow-up procedures.
  2. History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
  3. 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.
  4. Known HIV infection (there must be a negative HIV test at screening).
  5. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
  6. Current treatment with anti-viral therapy for HBV.
  7. 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.
  8. 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.
  9. New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction < 50%, or active ventricular arrhythmia requiring medication.
  10. Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
  11. Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) > 480 ms.
  12. Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
  13. 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).
  14. 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.
  15. Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
  16. 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.
  17. 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.
  18. Known CNS disease, except for treated asymptomatic CNS metastases.
  19. Known germline BRCA1/2 deleterious mutation, unless the participant is not an appropriate candidate for a PARP-inhibitor.
  20. Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
  21. Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
  22. 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).
  23. Uncontrolled pleural effusion, pericardial effusion or ascites.
  24. Uncontrolled tumor-related pain.
  25. 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.
  26. Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
  27. Grade >= 2 peripheral neuropathy.
  28. History of Type I or Type II diabetes mellitus requiring insulin.
  29. Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  30. History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
  31. Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
  32. 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.
  33. Prior treatment with an Akt inhibitor.
  34. Active or history of autoimmune disease or immune deficiency.
  35. 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.
  36. Prior allogeneic stem cell or solid organ transplantation.
  37. 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.
  38. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  39. Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
  40. 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.
  41. 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.

Sites / Locations

  • USA Mitchell Cancer Institute
  • Highlands Oncology Group
  • UCLA
  • Kaiser Permanente-SCPMG; Oncology Research
  • Stanford Cancer Center
  • Kaiser Permanente - Franklin
  • Stamford Hospital; BCC, MOHR
  • Holy Cross Hospital
  • Memorial Healthcare System - Memorial Regional Hospital
  • Memorial Cancer Institute at Memorial West
  • Winship Cancer Institute
  • Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME
  • Rush University
  • Ochsner Clinic Foundation
  • Ochsner Health System
  • University of Maryland Medical Center
  • Mercy Medical Center
  • Medstar Franklin Square Medical Center
  • St. Joseph Mercy Hospital; Cancer Care Center.
  • Henry Ford Health System
  • Jackson Oncology Associates, PLLC
  • CHI Health Saint Francis; Oncology
  • Dartmouth Hitchcock Medical Center
  • Hackensack Univ Med Ctr
  • Wake Forest University Baptist Medical Center
  • Kaiser Permanente - Portland
  • Oregon Health and Science University
  • Charleston Oncology, P .A
  • Greenville Health System; Cancer Center
  • The West Clinic; West Cancer Center
  • Vanderbilt Univ Medical Ctr
  • Fundación CENIT para la Investigación en Neurociencias
  • Inst. Angel Roffo; Haematology
  • Hospital Britanico
  • Instituto Medico Rio Cuarto
  • Centro Oncologico Riojano Integral (CORI)
  • Fundacion Scherbovsky
  • Macquarie University Hospital
  • Mid North Coast Cancer Institute
  • Royal North Shore Hospital; Department of Medical Oncology
  • Calvary Mater Newcastle; Medical Oncology
  • Princess Alexandra Hospital
  • Adelaide Cancer Centre
  • Monash Health Monash Medical Centre
  • Peter MacCallum Cancer Centre; Medical Oncology
  • Sunshine Hospital; Oncology Research
  • St John of God Hospital; Bendat Cancer Centre
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
  • Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
  • AZ Maria Middelares
  • Jessa Zkh (Campus Virga Jesse)
  • Hospital Sao Rafael - HSR
  • Hospital das Clinicas - UFRGS
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
  • MHAT Nadezhda
  • Cross Cancer Institute ; Dept of Medical Oncology
  • Fraser Valley Centre British Columbia Cancer Agency
  • Cancer Care Manitoba
  • Royal Victoria Hospital
  • The Ottawa Hospital Cancer Centre
  • McGill University; Glen Site; Oncology
  • Jewish General Hospital; Research Unit
  • Hopital du Saint Sacrement
  • Clinica del Country
  • Oncólogos de Occidente
  • Clinica CIMCA
  • Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Herlev Hospital; Afdeling for Kræftbehandling
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Docrates Cance Center
  • KYS Sadesairaala; Syopatautien poliklinikka
  • VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
  • Centre Eugene Marquis; Service d'oncologie
  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Queen Mary Hospital; Dept of Medicine
  • Tuen Mun Hospital; Clinical Onc
  • Prince of Wales Hospital; Department of Clinical Onocology
  • Sahyadri Super Specialty Hospital Hadapsar
  • Shaare Zedek Medical Center
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • ASU FC S. M. DELLA MISERICORDIA; Oncologia
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  • ASST DI LECCO; Oncologia Medica
  • IRCCS Istituto Clinico Humanitas; Oncologia
  • Ospedale Civile; Unita Operativa Di Oncologia Medica
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Aichi Cancer Center Hospital
  • Fukushima Medical University Hospital
  • Gunma Prefectural Cancer Center
  • Hiroshima University Hospital
  • Kanagawa Cancer Center
  • Kumamoto Shinto General Hospital
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • Kyungpook National University Medical Center
  • National Cancer Center
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Seoul St Mary's Hospital
  • Samsung Medical Center
  • Investigacion Oncofarmaceutica
  • Health Pharma Professional Research
  • Christus Muguerza Clinica Vidriera
  • Auckland City Hospital, Cancer and Blood Research
  • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
  • Wellington Regional Hospital; Clinical Trials Unit
  • Centro Medico Monte Carmelo
  • Instituto Regional de Enfermedades Neoplasicas
  • Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion
  • Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
  • Hospital Arzobispo Loayza
  • Oncosalud Sac; Oncología
  • Instituto Nacional de Enfermedades Neoplasicas
  • Clinica Ricardo Palma
  • Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Wielkopolskie Centrum Onkologii
  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
  • Hospital da Luz; Departamento de Oncologia Medica
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Hospital Beatriz Angelo; Departamento de Oncologia
  • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • IPO do Porto; Servico de Oncologia Medica
  • Oncology Center Sf. Nectarie
  • Arkhangelsk Regional Clinical Oncology Dispensary
  • University ?linic of headaches
  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
  • FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
  • Limited Liability Company "RC Medical"
  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • National Cancer Centre; Medical Oncology
  • National Hospital; Oncotherapy Dept
  • Cancercare
  • Wits Clinical Research
  • Cancercare
  • Wilgers Oncology Centre
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Centro Integral Oncologico Clara Campal; Servicio de Oncología
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Universitätsspital Basel
  • Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie
  • China Medical University Hospital; Surgery
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • National Taiwan Uni Hospital; General Surgery
  • Chang Gung Memorial Hosipital at Linkou
  • Chulalongkorn Hospital; Medical Oncology
  • Rajavithi Hospital; Division of Medical Oncology
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
  • Khonkaen Hospital
  • Songklanagarind Hospital; Department of Oncology
  • Memorial Ankara Hastanesi
  • Medipol University Medical Faculty; Oncology Department
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
  • Regional Oncology Center; Department of Mammology
  • Chemotherapy SI Dnipropetrovsk MA of MOHU
  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
  • MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
  • Municipal Institution Odesa Regional Clinical Hospital
  • RCI Sumy Regional Clinical Oncological Dispensary
  • BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1
  • The Royal Marsden Hospital, Fulham
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cohort 1 Arm A

Cohort 1 Arm B

Cohort 1 Arm C

Cohort 2 Arm A

Cohort 2 Arm B

Arm Description

PD-L1 Non-Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1:1 ratio.

PD-L1 Non-Positive Participants receiving Paclitaxel, Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.

PD-L1 Non-Positive Participants receiving Paclitaxel, Placebo for Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.

PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1 ratio.

PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Placebo for Ipatasertib. Participants will be randomised in a 1:1 ratio.

Outcomes

Primary Outcome Measures

Investigator-assessed Progression Free Survival (PFS)
Defined as the time from randomisation to the first occurrence of disease progression, as determined locally according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first.
Overall Survival (OS)
Defined as the time from randomisation to death from any cause.

Secondary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
Severity determined by the investigator according to the NCI Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

Full Information

First Posted
November 7, 2019
Last Updated
March 22, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04177108
Brief Title
A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.
Official Title
A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Breast Cancer
Keywords
Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Paclitaxel, Atezolizumab, Ipatasertib, Antibodies, Monoclonal, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Arm A
Arm Type
Experimental
Arm Description
PD-L1 Non-Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1:1 ratio.
Arm Title
Cohort 1 Arm B
Arm Type
Experimental
Arm Description
PD-L1 Non-Positive Participants receiving Paclitaxel, Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.
Arm Title
Cohort 1 Arm C
Arm Type
Active Comparator
Arm Description
PD-L1 Non-Positive Participants receiving Paclitaxel, Placebo for Ipatasertib and Placebo for Atezolizumab. Participants will be randomised in a 1:1:1 ratio.
Arm Title
Cohort 2 Arm A
Arm Type
Experimental
Arm Description
PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Ipatasertib. Participants will be randomised in a 1:1 ratio.
Arm Title
Cohort 2 Arm B
Arm Type
Active Comparator
Arm Description
PD-L1 Positive Participants receiving Paclitaxel, Atezolizumab and Placebo for Ipatasertib. Participants will be randomised in a 1:1 ratio.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab will be administered to participants by intravenous (IV) infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Intervention Description
Ipatasertib will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered to participants at a starting dose of 80 mg/m^2 by IV infusion for 3 of 4 weeks on Days 1, 8, and 15 of each 28-day cycle unless deferred to Day 22 because of an adverse event.
Intervention Type
Drug
Intervention Name(s)
Placebo for Atezolizumab
Intervention Description
Placebo will be administered to participants at a fixed dose of 840 mg IV infusion for Atezolizumab on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo for Ipatasertib
Intervention Description
Placebo will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for Ipatasertib for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.
Primary Outcome Measure Information:
Title
Investigator-assessed Progression Free Survival (PFS)
Description
Defined as the time from randomisation to the first occurrence of disease progression, as determined locally according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first.
Time Frame
Up to 49 months
Title
Overall Survival (OS)
Description
Defined as the time from randomisation to death from any cause.
Time Frame
Up to 49 months
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Description
Severity determined by the investigator according to the NCI Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Time Frame
Up to 49 months
Other Pre-specified Outcome Measures:
Title
Overall Response Rate (ORR)
Description
Defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1.
Time Frame
Up to 49 months
Title
Duration of Response (DOR)
Description
Defined as the time from the first occurrence of a documented objective response to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame
Up to 49 months
Title
Clinical Benefit Rate (CBR)
Description
Defined as the proportion of participants who have a CR, PR, or stable disease for >= 24 weeks, as determined by the investigator according to RECIST v1.1.
Time Frame
Up to 49 months
Title
Mean and mean changes from baseline score in participant-reported function (role, physical)
Description
Assessed by EORTC QLC-C30 Selected Scales: Physical Function (Questions 1-5) and Role Function (Questions 6 and 7).
Time Frame
Up to 49 months
Title
Mean and mean changes from baseline score in function in participant-reported Global Health Status (GHS)/Quality of Life (QoL) by assessment timepoint and between treatment arms
Description
Assessed by EORTC QLC-C30 Selected Scale: GHS/QoL (Questions 29 and 30).
Time Frame
Up to 49 months
Title
Progression Free Survival (PFS) for participants with Programmed Death-Ligand 1 (PD-L1)-non-positive tumors
Description
Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Time Frame
Up to 49 months
Title
Overall Survival (OS) for participants with PD-L1-non-positive tumors
Description
Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Time Frame
Up to 49 months
Title
Overall Response Rate (ORR) for participants with PD-L1-non-positive tumors
Description
Participants administered with atezolizumab in combination with ipatasertib and paclitaxel (Arm A vs. Arm B in Cohort 1).
Time Frame
Up to 49 months
Title
Progression Free Survival (PFS) for participants with PIK3CA/AKT1/PTEN-altered tumors
Description
Participants in experimental treatment arm will be compared with participants in control treatment arm.
Time Frame
Up to 49 months
Title
Overall Survival (OS) for participants with PIK3CA/AKT1/PTEN-altered tumors
Description
Participants in experimental treatment arm will be compared with participants in control treatment arm.
Time Frame
Up to 49 months
Title
Overall Response Rate (ORR) for participants with PIK3CA/AKT1/PTEN-altered tumors
Description
Participants in experimental treatment arm will be compared with participants in control treatment arm.
Time Frame
Up to 49 months
Title
Duration of Response (DOR) for participants with PIK3CA/AKT1/PTEN-altered tumors
Description
Participants in experimental treatment arm will be compared with participants in control treatment arm.
Time Frame
Up to 49 months
Title
Plasma concentration of ipatasertib and its metabolite (G037720) (ng/mL) at specified timepoints
Time Frame
Up to 49 months
Title
Serum concentration of atezolizumab (µg/mL) at specified timepoints
Time Frame
Up to 49 months
Title
Level of Anti-Drug Antibodies (ADAs) (%) to Atezolizumab
Time Frame
Up to 49 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
USA Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Kaiser Permanente-SCPMG; Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5820
Country
United States
Facility Name
Kaiser Permanente - Franklin
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Stamford Hospital; BCC, MOHR
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Memorial Healthcare System - Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Cancer Institute at Memorial West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Medstar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
St. Joseph Mercy Hospital; Cancer Care Center.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
CHI Health Saint Francis; Oncology
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack Univ Med Ctr
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Kaiser Permanente - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97229
Country
United States
Facility Name
Charleston Oncology, P .A
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Greenville Health System; Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4292
Country
United States
Facility Name
The West Clinic; West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt Univ Medical Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Inst. Angel Roffo; Haematology
City
Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Hospital Britanico
City
Ciudad Autonoma Bs As
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Instituto Medico Rio Cuarto
City
Cordoba
ZIP/Postal Code
X5800AEU
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Mid North Coast Cancer Institute
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Royal North Shore Hospital; Department of Medical Oncology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle; Medical Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Monash Health Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sunshine Hospital; Oncology Research
City
St Albans
State/Province
Victoria
Country
Australia
Facility Name
St John of God Hospital; Bendat Cancer Centre
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
MHAT Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Cross Cancer Institute ; Dept of Medical Oncology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Fraser Valley Centre British Columbia Cancer Agency
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 6C2
Country
Canada
Facility Name
McGill University; Glen Site; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Jewish General Hospital; Research Unit
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Facility Name
Oncólogos de Occidente
City
Pereira
ZIP/Postal Code
600004
Country
Colombia
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Docrates Cance Center
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
KYS Sadesairaala; Syopatautien poliklinikka
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Facility Name
Centre Eugene Marquis; Service d'oncologie
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
City
Kifisia
ZIP/Postal Code
145 64
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Facility Name
Queen Mary Hospital; Dept of Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital; Clinical Onc
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital; Department of Clinical Onocology
City
Shatin
Country
Hong Kong
Facility Name
Sahyadri Super Specialty Hospital Hadapsar
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411028
Country
India
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
ASU FC S. M. DELLA MISERICORDIA; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST DI LECCO; Oncologia Medica
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas; Oncologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Civile; Unita Operativa Di Oncologia Medica
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57100
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
003-722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigacion Oncofarmaceutica
City
La Paz
State/Province
BAJA California SUR
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Christus Muguerza Clinica Vidriera
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64570
Country
Mexico
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Wellington Regional Hospital; Clinical Trials Unit
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Centro Medico Monte Carmelo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Instituto Regional de Enfermedades Neoplasicas
City
Arequipa
ZIP/Postal Code
04002
Country
Peru
Facility Name
Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion
City
Lima
ZIP/Postal Code
07016
Country
Peru
Facility Name
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Hospital Arzobispo Loayza
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Oncosalud Sac; Oncología
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Clinica Ricardo Palma
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
City
?ód?
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital da Luz; Departamento de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Beatriz Angelo; Departamento de Oncologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Oncology Dispensary
City
Arkhangelsk
State/Province
Arhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
University ?linic of headaches
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Limited Liability Company "RC Medical"
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
National Hospital; Oncotherapy Dept
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Cancercare
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Wits Clinical Research
City
Johannesberg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Cancercare
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia; Servicio de Oncología
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
China Medical University Hospital; Surgery
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hosipital at Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Khonkaen Hospital
City
Khonkaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Regional Oncology Center; Department of Mammology
City
Chernigiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Chemotherapy SI Dnipropetrovsk MA of MOHU
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
RCI Sumy Regional Clinical Oncological Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
The Royal Marsden Hospital, Fulham
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this 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.

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