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A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)

Primary Purpose

Breast Cancer

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

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and organ function within 14 days prior to treatment initiation
  • Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
  • HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease <=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy.
  • Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis
  • Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status
  • 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

Exclusion Criteria:

  • Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
  • Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)
  • History of or known presence of brain or spinal cord metastases
  • Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
  • Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
  • Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)
  • Known human immunodeficiency virus (HIV) infection
  • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study)
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram [ECG] abnormalities).
  • Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
  • Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
  • Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)
  • 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 or active bowel inflammation
  • Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections)
  • 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 treatment
  • Grade >=2 peripheral neuropathy

Sites / Locations

  • UCSD Moores Cancer Center
  • USC Norris Cancer Center
  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach
  • Kaiser Permanente - Oakland
  • Kaiser Permanente - Roseville
  • UC Davis; Comprehensive Cancer Center
  • Kaiser Permanente Sacramento Medical Center
  • Kaiser Permanente - San Francisco (2238 Geary)
  • UCSF Comprehensive Cancer Ctr
  • K. Permanente - San Jose
  • Kaiser Permanente - San Leandro
  • K. Permanente - Santa Clara
  • Kaiser Permanente - South San Francisco
  • Kaiser Permanente - Vallejo
  • K. Permanente - Walnut Creek
  • Memorial Regional Hospital
  • Mount Sinai Comprehensive Cancer Center
  • UF Health Cancer Center at Orlando Health
  • Memorial Hospital West
  • University of Maryland
  • Mercy Medical Center
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center at Westchester
  • Memorial Sloan Kettering
  • West Clinic
  • Texas Oncology, P.A.
  • UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy
  • Oncology Consultants PA
  • Fundación CENIT para la Investigación en Neurociencias
  • Hosp Provincial D. Centenarios; Oncology Dept
  • Chris O'Brien Lifehouse
  • Calvary Mater Newcastle; Medical Oncology
  • Westmead Hospital; Medical Oncology
  • Mater Hospital; Cancer Services
  • Cabrini Medical Centre; Oncology
  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
  • Cliniques Universitaires St-Luc
  • GHdC Site Notre Dame
  • UZ Leuven Gasthuisberg
  • Santa Casa de Misericordia de Salvador
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital do Câncer de Londrina
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Faculdade de Medicina do ABC - FMABC
  • Hospital Perola Byington
  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
  • Jewish General Hospital
  • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Clinica CIMCA
  • ICIMED Instituto de Investigación en Ciencias Médicas
  • Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • CHU Besançon - Hôpital Jean Minjoz
  • Polyclinique Bordeaux Nord Aquitaine
  • Centre Georges Francois Leclerc; Oncologie 3
  • ICM; Medecine B3
  • Centre Catherine De Sienne
  • APHP - Hospital Saint Louis
  • Institut Jean Godinot; Oncologie Medicale
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
  • Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
  • Praxis Dr.med. Katja Ziegler-Löhr
  • Dres. Andreas Köhler und Roswitha Fuchs
  • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
  • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • Universitätsklinikum Würzburg; Frauenklinik
  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Agioi Anargyroi; 3Rd Dept. of Medical Oncology
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Orszagos Onkologial Intezet; Onkologiai Osztaly X
  • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Hetenyi Geza County Hospital; Onkologiai Kozpont
  • Zala County Hospital ICU
  • Indraprastha Apollo Hospitals
  • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • Ospedale Santa Maria Annunziata; Oncologia
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Kyushu Cancer Center;Breast Oncology
  • Fukushima Medical University Hospital
  • Hyogo Medical University Hospital
  • St. Marianna University Hospital
  • Kanagawa Cancer Center
  • Tokai University Hospital
  • Kumamoto Shinto General Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • National Hospital Organization Osaka National Hospital
  • Kinki University Hospital, Faculty of Medicine; Surgery
  • Saitama Cancer Center, Breast Oncology
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • St. Luke's International Hospital
  • The Cancer Institute Hospital of JFCR
  • Showa University Hospital; Breast Surgery
  • National Cancer Center
  • Inha University Hospital
  • Seoul National University Bundang Hospital
  • Severance Hospital, Yonsei University Health System
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Centro Medico Dalinde
  • Centro Médico Zambrano Hellion
  • Merida | Investigacion Clinica
  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
  • Clinical Hospital; Oncology Department
  • PHI University Clinic of Radiotherapy and Oncology; Breast malignancy
  • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
  • Centro Medico Monte Carmelo
  • Hospital Daniel Alcides Carrion
  • Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
  • Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica
  • Oncosalud Sac; Oncología
  • Instituto Nacional de Enfermedades Neoplasicas
  • Clinica Ricardo Palma
  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte
  • Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
  • Arkhangelsk Regional Clinical Oncology Dispensary
  • Moscow City Oncology Hospital #62
  • Blokhin Cancer Research Center; Combined Treatment
  • Ivanovo Regional Oncology Dispensary
  • SBIH Kaluga Region Clinical Oncology Dispensary
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
  • FSI Rostov research oncological institute of MoH and SD of RF; PAD
  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Institute of Oncology Ljubljana
  • Medical Oncology Centre of Rosebank; Oncology
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital Clinic Barcelona; Servicio de oncologia
  • Hospital de Donostia; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Clinico Universitario; Oncologia
  • Chi Mei Medical Center Liou Ying Campus
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • National Taiwan Uni Hospital; General Surgery
  • Ankara Bilkent City Hospital
  • Dicle Uni Medical Faculty; Internal Medicine
  • Medipol University Medical Faculty; Oncology Department
  • Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
  • Katip Celebi University Ataturk Training and Research Hospital; Oncology
  • Sakarya University Medical School; Medical Oncology
  • Chemotherapy SI Dnipropetrovsk MA of MOHU
  • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
  • National Cancer Institute MOH of Ukraine
  • Lviv State Oncological Regional Treatment and Diagnostic Center
  • Velindre Cancer Centre
  • University Hospital coventry; Oncology Department
  • The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
  • Royal Marsden Hospital - London
  • Derriford Hospital
  • Royal Stoke University Hospital
  • Royal Marsden Hospital; Dept of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ipatasertib + Paclitaxel

Placebo + Paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)

Secondary Outcome Measures

Objective Response Rate (ORR)
Proportion of participants with an objective response (ORR), defined as partial response or complete response on 2 consecutive occasions ≥4 weeks apart) as determined by the Investigator using RECIST v.1.1
Duration of Response (DOR)
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause.
Clinical Benefit Rate (CBR)
Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.
Overall Survival (OS)
Time from randomization to death from any cause.
Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score
GHS/HRQoL scores, assessed using selected questions from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Time to Deterioration in Pain
Time to deterioration in pain is defined as the first minimally important increase of >10 points from the baseline pain scale score of selected questions of the EORTC QLQ-C30 and will only be assessed in the cohort with HR+/HER2- breast cancer participants.
Incidence and Severity of Adverse Events (AEs)
Percentage of participants with an adverse event (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0, including analysis of pre-specified AEs.
Changes in Vital Signs
Change from baseline in selected vital signs.
Changes in Targeted Laboratory Results
Change from baseline in selected laboratory test results.
Plasma Concentration of Ipatasertib and Its Metabolite (G-037720)

Full Information

First Posted
November 7, 2017
Last Updated
February 7, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03337724
Brief Title
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Acronym
IPATunity130
Official Title
A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2018 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipatasertib + Paclitaxel
Arm Type
Experimental
Arm Title
Placebo + Paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Intervention Description
Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel, 80 mg/square meter (m^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo, administered orally QD on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression-Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of participants with an objective response (ORR), defined as partial response or complete response on 2 consecutive occasions ≥4 weeks apart) as determined by the Investigator using RECIST v.1.1
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Title
Duration of Response (DOR)
Description
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause.
Time Frame
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Title
Clinical Benefit Rate (CBR)
Description
Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Title
Overall Survival (OS)
Description
Time from randomization to death from any cause.
Time Frame
From randomization up to death from any cause, up to approximately 53 months
Title
Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score
Description
GHS/HRQoL scores, assessed using selected questions from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Time Frame
From Day 1 of Cycle 1 up to approximately 53 months
Title
Time to Deterioration in Pain
Description
Time to deterioration in pain is defined as the first minimally important increase of >10 points from the baseline pain scale score of selected questions of the EORTC QLQ-C30 and will only be assessed in the cohort with HR+/HER2- breast cancer participants.
Time Frame
From Day 1 of Cycle 1 up to approximately 53 months
Title
Incidence and Severity of Adverse Events (AEs)
Description
Percentage of participants with an adverse event (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0, including analysis of pre-specified AEs.
Time Frame
From randomization up to approximately 53 months
Title
Changes in Vital Signs
Description
Change from baseline in selected vital signs.
Time Frame
From randomization up to approximately 53 months
Title
Changes in Targeted Laboratory Results
Description
Change from baseline in selected laboratory test results.
Time Frame
From randomization up to approximately 53 months
Title
Plasma Concentration of Ipatasertib and Its Metabolite (G-037720)
Time Frame
Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Adequate hematologic and organ function within 14 days prior to treatment initiation Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy) HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease <=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy. Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status 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 Exclusion Criteria: Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval) History of or known presence of brain or spinal cord metastases Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer) Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed) History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents) Known human immunodeficiency virus (HIV) infection Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study) Pregnant or breastfeeding, or intending to become pregnant during the study Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram [ECG] abnormalities). Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy) 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 or active bowel inflammation Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections) 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 treatment Grade >=2 peripheral neuropathy
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
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Kaiser Permanente - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
UC Davis; Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente - San Francisco (2238 Geary)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Comprehensive Cancer Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
K. Permanente - San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente - San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
K. Permanente - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente - South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
K. Permanente - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32824
Country
United States
Facility Name
Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
University of Maryland
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
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
West Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Oncology Consultants PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Hosp Provincial D. Centenarios; Oncology Dept
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Calvary Mater Newcastle; Medical Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital; Medical Oncology
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Hospital; Cancer Services
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Cabrini Medical Centre; Oncology
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
City
Bull Creek
State/Province
Western Australia
ZIP/Postal Code
6149
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital do Câncer de Londrina
City
Londrina
State/Province
PR
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Faculdade de Medicina do ABC - FMABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Sociedad de Investigaciones Medicas Ltda (SIM)
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
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
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
ICM; Medecine B3
City
Montpellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Catherine De Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
APHP - Hospital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Institut Jean Godinot; Oncologie Medicale
City
Reims CEDEX
ZIP/Postal Code
51056
Country
France
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Praxis Dr.med. Katja Ziegler-Löhr
City
Köln
ZIP/Postal Code
50679
Country
Germany
Facility Name
Dres. Andreas Köhler und Roswitha Fuchs
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Universitätsklinikum Würzburg; Frauenklinik
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
City
Athens
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
Orszagos Onkologial Intezet; Onkologiai Osztaly X
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Hetenyi Geza County Hospital; Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Zala County Hospital ICU
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Santa Maria Annunziata; Oncologia
City
Bagno a Ripoli
State/Province
Toscana
ZIP/Postal Code
50012
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
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center;Breast Oncology
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hyogo Medical University Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Kinki University Hospital, Faculty of Medicine; Surgery
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Cancer Center, Breast Oncology
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University Hospital; Breast Surgery
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Centro Medico Dalinde
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Centro Médico Zambrano Hellion
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Merida | Investigacion Clinica
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97125
Country
Mexico
Facility Name
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Clinical Hospital; Oncology Department
City
Bitola
ZIP/Postal Code
7000
Country
North Macedonia
Facility Name
PHI University Clinic of Radiotherapy and Oncology; Breast malignancy
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Centro Medico Monte Carmelo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital Daniel Alcides Carrion
City
Callao
ZIP/Postal Code
07021
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 Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica
City
Lima
ZIP/Postal Code
15102
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
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
City
Trujillo
ZIP/Postal Code
13014
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; III Klin. Radioter. i Chemioter.
City
Gliwice
ZIP/Postal Code
44-101
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
Arkhangelsk Regional Clinical Oncology Dispensary
City
Arkhangelsk
State/Province
Arhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Combined Treatment
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
SBIH Kaluga Region Clinical Oncology Dispensary
City
Kaluga
ZIP/Postal Code
248007
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
Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
FSI Rostov research oncological institute of MoH and SD of RF; PAD
City
Rostov-on-Don
ZIP/Postal Code
344037
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 University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Medical Oncology Centre of Rosebank; Oncology
City
Johannesburg
ZIP/Postal Code
2196
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
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
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 del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona; Servicio de oncologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Donostia; Servicio de Oncologia
City
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario; Oncologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Chi Mei Medical Center Liou Ying Campus
City
Liuying Township
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
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
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Dicle Uni Medical Faculty; Internal Medicine
City
Diyarbakir
ZIP/Postal Code
10000
Country
Turkey
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Facility Name
Katip Celebi University Ataturk Training and Research Hospital; Oncology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Sakarya University Medical School; Medical Oncology
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Chemotherapy SI Dnipropetrovsk MA of MOHU
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
National Cancer Institute MOH of Ukraine
City
Kiev
ZIP/Postal Code
36022
Country
Ukraine
Facility Name
Lviv State Oncological Regional Treatment and Diagnostic Center
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
University Hospital coventry; Oncology Department
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept of Medical Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34860318
Citation
Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.
Results Reference
derived

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A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

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