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)

• ClinicalTrials.gov Identifier: NCT03337724
• Recruitment Status: Completed
• First Posted: November 9, 2017
• Results First Posted: March 12, 2024
• Last Update Posted: March 12, 2024
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Ipatasertib; Drug: Paclitaxel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 579 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 6, 2018
• Actual Primary Completion Date: January 4, 2023
• Actual Study Completion Date: January 4, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ipatasertib + Paclitaxel	Drug: Ipatasertib; 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.; Drug: Paclitaxel; 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.
Experimental: Placebo + Paclitaxel	Drug: Paclitaxel; 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.; Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. Cohort A: Progression-Free Survival (PFS) [ Time Frame: From randomization up to 27 months ]
   PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or death from any cause, whichever occurred first, assessed up to 27 months for this outcome measure. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
2. Cohort B: PFS [ Time Frame: From randomization up to 24.4 months ]
   PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 24.4 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Abbreviation used in statistical analysis: PI3K=phosphoinositide 3-kinase and mTOR=mammalian target of rapamycin inhibitor.
3. Cohort C: PFS [ Time Frame: From enrollment up to 31 months ]
   PFS for Cohort C was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Secondary Outcome Measures :

1. Cohort A and B: Objective Response Rate (ORR) [ Time Frame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B ]
   ORR was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.
2. Cohort C: ORR [ Time Frame: From enrollment up to 31 months ]
   ORR was defined as percentage of participants with PR or CR on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point.
3. Cohort A and B: Duration of Response (DOR) [ Time Frame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B ]
   DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
4. Cohort C: DOR [ Time Frame: From enrollment up to 31 months ]
   DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
5. Cohort A and B: Clinical Benefit Rate (CBR) [ Time Frame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B ]
   CBR was defined as percentage of participants with an objective response (CR or PR), or stable disease (SD) for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1. assessed up to From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.
6. Cohort C: CBR [ Time Frame: From enrollment up to 31 months ]
   CBR was defined as percentage of participants with an objective response (CR or PR), or SD for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1 assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point.
7. Overall Survival (OS) [ Time Frame: From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C ]
   OS was defined as the time from randomization to death from any cause.
8. Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 [ Time Frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days) ]
   European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.
9. Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 [ Time Frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days) ]
   EORTC QLQ-C30 is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement.
10. Cohort B: Time to Deterioration (TTD) in Pain [ Time Frame: Baseline up to 24.4 months ]
    Time to deterioration in GHS/HRQoL was defined as the time from randomization to first observed ≥ 11-point increase from Baseline in pain scale score (Question 9 and 19) in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score, assessed up 24.4 months for this outcome measure. TTD was planned to be assessed only in cohort with HR+/HER2 - breast cancer participants (Cohort B). Questions 9 and 19 that assessed pain, used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scores were linearly transformed on a scale of 0 to 100, with higher scores indicating increased severity in symptoms.
11. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.
12. Number of Participants With at Least One Adverse Events of Special Interest (AESI) [ Time Frame: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the NCI CTCAE, Version 4.0. AESI include cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. Suspected transmission of an infectious agent by the study drug, Grade >= 3 fasting hyperglycemia, hepatotoxicity, diarrhea, rash, ALT/AST elevations. Grade >= 2 colitis/enterocolitis.
13. Cohorts A and B:Plasma Concentration of Ipatasertib [ Time Frame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) ]
14. Cohort C: Plasma Concentration of Ipatasertib [ Time Frame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) ]
15. Cohorts A and B: Plasma Concentration of G-037720 [ Time Frame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) ]
    G-037720 was a metabolite of ipatasertib.
16. Cohort C: Plasma Concentration of G-037720 [ Time Frame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) ]
    G-037720 was a metabolite of ipatasertib.
17. Cohort C: 1-year Event-free PFS Rate [ Time Frame: From enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year ]
    PFS was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first. Event-free PFS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Percentages are rounded off to the nearest decimal point. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.
18. Cohort C: 1-year Event-free OS Rate [ Time Frame: From enrollment up to death from any cause, up to 1 year ]
    OS was defined as the time from enrollment to death from any cause. Event-free OS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. Percentages were rounded off to the nearest decimal.
19. Cohort C: Serum Concentration of Atezolizumab [ Time Frame: Day 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days) ]
    As prespecified in the protocol, this outcome measure was applicable only to Cohort C.
20. Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Up to 45.5 months ]
    The numbers of ADA-positive participants after drug administration were summarized for participants exposed to atezolizumab. As prespecified in the protocol, this outcome measure was applicable only to Cohort C.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UCSD Moores Cancer Center

La Jolla, California, United States, 92093

USC Norris Cancer Center

Los Angeles, California, United States, 90033

USC Norris Cancer Center; USC Oncology Hematology Newport Beach

Newport Beach, California, United States, 92663

Kaiser Permanente - Oakland

Oakland, California, United States, 94611

Kaiser Permanente - Roseville

Roseville, California, United States, 95661

UC Davis; Comprehensive Cancer Center

Sacramento, California, United States, 95817

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States, 95825

Kaiser Permanente - San Francisco (2238 Geary)

San Francisco, California, United States, 94115

UCSF Comprehensive Cancer Ctr

San Francisco, California, United States, 94158

K. Permanente - San Jose

San Jose, California, United States, 95119

Kaiser Permanente - San Leandro

San Leandro, California, United States, 94577

K. Permanente - Santa Clara

Santa Clara, California, United States, 95051

Kaiser Permanente - South San Francisco

South San Francisco, California, United States, 94080

Kaiser Permanente - Vallejo

Vallejo, California, United States, 94589

K. Permanente - Walnut Creek

Walnut Creek, California, United States, 94596

United States, Florida

Memorial Regional Hospital

Hollywood, Florida, United States, 33021

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States, 33140

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States, 32824

Memorial Hospital West

Pembroke Pines, Florida, United States, 33028

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21287

United States, New York

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States, 10604

Memorial Sloan Kettering

New York, New York, United States, 10065

United States, Tennessee

West Clinic

Germantown, Tennessee, United States, 38138

United States, Texas

Texas Oncology, P.A.

Dallas, Texas, United States, 75246

UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy

Dallas, Texas, United States, 75390

Oncology Consultants PA

Houston, Texas, United States, 77030

Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina, C1125ABD

Hosp Provincial D. Centenarios; Oncology Dept

Rosario, Argentina, S2002KDS

Australia, New South Wales

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia, 2298

Westmead Hospital; Medical Oncology

Wentworthville, New South Wales, Australia, 2145

Australia, Queensland

Mater Hospital; Cancer Services

South Brisbane, Queensland, Australia, 4101

Australia, Victoria

Cabrini Medical Centre; Oncology

Malvern, Victoria, Australia, 3144

Australia, Western Australia

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

Bull Creek, Western Australia, Australia, 6149

Belgium

Cliniques Universitaires St-Luc

Bruxelles, Belgium, 1200

GHdC Site Notre Dame

Charleroi, Belgium, 6000

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Brazil

Santa Casa de Misericordia de Salvador

Salvador, BA, Brazil, 40050-410

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

Goiania, GO, Brazil, 74605-070

Hospital do Câncer de Londrina

Londrina, PR, Brazil, 86015-520

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, RJ, Brazil, 20560-120

Hospital Sao Lucas - PUCRS

Porto Alegre, RS, Brazil, 90610-000

Hospital Nossa Senhora da Conceicao

Porto Alegre, RS, Brazil, 91350-200

Faculdade de Medicina do ABC - FMABC

Santo Andre, SP, Brazil, 09060-650

Hospital Perola Byington

Sao Paulo, SP, Brazil, 01317-000

Canada, British Columbia

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Chile

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, Chile, 4800827

Costa Rica

Clinica CIMCA

San José, Costa Rica, 10103

ICIMED Instituto de Investigación en Ciencias Médicas

San José, Costa Rica, 10108

Czechia

Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

Brno, Czechia, 656 53

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, Czechia, 779 00

France

CHU Besançon - Hôpital Jean Minjoz

Besançon Cedex, France, 25030

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France, 33300

Centre Georges Francois Leclerc; Oncologie 3

Dijon, France, 21079

ICM; Medecine B3

Montpellier cedex 5, France, 34298

Centre Catherine De Sienne

Nantes, France, 44202

APHP - Hospital Saint Louis

Paris, France, 75475

Institut Jean Godinot; Oncologie Medicale

Reims CEDEX, France, 51056

Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, Germany, 10707

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg, Germany, 79110

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

Hamburg, Germany, 20246

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

Homburg/Saar, Germany, 66424

Praxis Dr.med. Katja Ziegler-Löhr

Köln, Germany, 50679

Dres. Andreas Köhler und Roswitha Fuchs

Langen, Germany, 63225

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

Minden, Germany, 32429

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

Recklinghausen, Germany, 45659

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

Rostock, Germany, 18059

Universitätsklinikum Würzburg; Frauenklinik

Würzburg, Germany, 97080

Greece

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, Greece, 115 22

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

Athens, Greece, 145 64

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, Greece, 546 45

Hungary

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, Hungary, 1122

Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

Miskolc, Hungary, 3501

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

Szeged, Hungary, 6720

Hetenyi Geza County Hospital; Onkologiai Kozpont

Szolnok, Hungary, 5004

Zala County Hospital ICU

Zalaegerszeg, Hungary, 8900

India

Indraprastha Apollo Hospitals

New Delhi, Delhi, India, 110076

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

New Delhi, Delhi, India, 110085

Italy

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

Napoli, Campania, Italy, 80131

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna, Italy, 40138

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Aviano, Friuli-Venezia Giulia, Italy, 33081

Ospedale Santa Maria Annunziata; Oncologia

Bagno a Ripoli, Toscana, Italy, 50012

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Padova, Veneto, Italy, 35128

Japan

Aichi Cancer Center Hospital

Aichi, Japan, 464-8681

National Cancer Center Hospital East

Chiba, Japan, 277-8577

National Hospital Organization Kyushu Cancer Center;Breast Oncology

Fukuoka, Japan, 811-1395

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

St. Marianna University Hospital

Kanagawa, Japan, 216-8511

Kanagawa Cancer Center

Kanagawa, Japan, 241-8515

Tokai University Hospital

Kanagawa, Japan, 259-1193

Kumamoto Shinto General Hospital

Kumamoto, Japan, 862-8655

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Okayama University Hospital

Okayama, Japan, 700-8558

National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006

Kinki University Hospital, Faculty of Medicine; Surgery

Osaka, Japan, 589-8511

Saitama Cancer Center, Breast Oncology

Saitama, Japan, 362-0806

Shizuoka Cancer Center

Shizuoka, Japan, 411-8777

National Cancer Center Hospital

Tokyo, Japan, 104-0045

St. Luke's International Hospital

Tokyo, Japan, 104-8560

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Showa University Hospital; Breast Surgery

Tokyo, Japan, 142-8666

Korea, Republic of

National Cancer Center

Goyang-si, Korea, Republic of, 10408

Inha University Hospital

Incheon, Korea, Republic of, 22332

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of, 463-707

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Mexico

Centro Medico Dalinde

Cdmx, Mexico CITY (federal District), Mexico, 06760

Centro Médico Zambrano Hellion

Monterrey, Nuevo LEON, Mexico, 66278

Merida | Investigacion Clinica

Mérida, Yucatan, Mexico, 97125

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

Mexico City, Mexico, 03100

North Macedonia

Clinical Hospital; Oncology Department

Bitola, North Macedonia, 7000

PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

Skopje, North Macedonia, 1000

PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

Skopje, North Macedonia, 1000

Peru

Centro Medico Monte Carmelo

Arequipa, Peru, 04001

Hospital Daniel Alcides Carrion

Callao, Peru, 07021

Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

Lima, Peru, 15088

Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica

Lima, Peru, 15102

Oncosalud Sac; Oncología

Lima, Peru, 41

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru, Lima 34

Clinica Ricardo Palma

San Isidro, Peru, Lima 27

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, Peru, 13014

Poland

Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

?ód?, Poland, 93-338

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

Gliwice, Poland, 44-101

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

Warszawa, Poland, 02-781

Russian Federation

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, Russian Federation, 163045

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423

Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

Moscow, Moskovskaja Oblast, Russian Federation, 125284

Blokhin Cancer Research Center; Combined Treatment

Moskva, Moskovskaja Oblast, Russian Federation, 115478

FSI Rostov research oncological institute of MoH and SD of RF; PAD

Rostov-on-Don, Rostov, Russian Federation, 344037

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan, Tatarstan, Russian Federation, 420029

Ivanovo Regional Oncology Dispensary

Ivanovo, Russian Federation, 153040

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, Russian Federation, 248007

Singapore

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, Singapore, 119228

National Cancer Centre; Medical Oncology

Singapore, Singapore, 168583

Slovenia

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

South Africa

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, South Africa, 2196

Spain

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon de La Plana, Castellon, Spain, 12002

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain, 14004

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña, Spain, 15706

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, Spain, 28222

Hospital del Mar; Servicio de Oncologia

Barcelona, Spain, 08003

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain, 08035

Hospital Clinic Barcelona; Servicio de oncologia

Barcelona, Spain, 08036

Hospital de Donostia; Servicio de Oncologia

Guipuzcoa, Spain, 20014

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain, 28034

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, Spain, 28050

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Hospital Clinico Universitario; Oncologia

Valencia, Spain, 46010

Taiwan

Chi Mei Medical Center Liou Ying Campus

Liuying Township, Taiwan, 736

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei City, Taiwan, 11259

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, Taiwan, 00112

National Taiwan Uni Hospital; General Surgery

Taipei, Taiwan, 100

Turkey

Ankara Bilkent City Hospital

Ankara, Turkey, 06490

Dicle Uni Medical Faculty; Internal Medicine

Diyarbakir, Turkey, 10000

Medipol University Medical Faculty; Oncology Department

Istanbul, Turkey, 34214

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

Istanbul, Turkey, 34384

Katip Celebi University Ataturk Training and Research Hospital; Oncology

Izmir, Turkey, 35360

Sakarya University Medical School; Medical Oncology

Sakarya, Turkey, 54100

Ukraine

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, Ukraine, 49102

Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

Kiev, Ukraine, 03115

National Cancer Institute MOH of Ukraine

Kiev, Ukraine, 36022

Lviv State Oncological Regional Treatment and Diagnostic Center

Lviv, Ukraine, 79031

United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

University Hospital coventry; Oncology Department

Coventry, United Kingdom, CV2 2DX

The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

Glasgow, United Kingdom, G12 0YN

Royal Marsden Hospital - London

London, United Kingdom, SW3 6JJ

Derriford Hospital

Plymouth, United Kingdom, PL6 8BT

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom, ST4 6QG

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] February 17, 2022

Statistical Analysis Plan  [PDF] March 12, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03337724
• Other Study ID Numbers: CO40016; 2017-001548-36 ( EudraCT Number )
• First Posted: November 9, 2017
• Results First Posted: March 12, 2024
• Last Update Posted: March 12, 2024
• Last Verified: February 2024

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

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Ipatasertib; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors; Enzyme Inhibitors