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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03337724




Registration number
NCT03337724
Ethics application status
Date submitted
7/11/2017
Date registered
9/11/2017
Date last updated
17/06/2020

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2017-001548-36
Secondary ID [2] 0 0
CO40016
Universal Trial Number (UTN)
Trial acronym
IPATunity130
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Placebo

Experimental: Ipatasertib + Paclitaxel -

Experimental: Placebo + Paclitaxel -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months
Secondary outcome [4] 0 0
Overall Survival (OS) - Time from randomization to death from any cause.
Timepoint [4] 0 0
From randomization up to death from any cause, up to approximately 53 months
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
From Day 1 of Cycle 1 up to approximately 53 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
From Day 1 of Cycle 1 up to approximately 53 months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
From randomization up to approximately 53 months
Secondary outcome [8] 0 0
Changes in Vital Signs - Change from baseline in selected vital signs.
Timepoint [8] 0 0
From randomization up to approximately 53 months
Secondary outcome [9] 0 0
Changes in Targeted Laboratory Results - Change from baseline in selected laboratory test results.
Timepoint [9] 0 0
From randomization up to approximately 53 months
Secondary outcome [10] 0 0
Plasma Concentration of Ipatasertib and Its Metabolite (G-037720)
Timepoint [10] 0 0
Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital; Medical Oncology - Wentworthville
Recruitment hospital [4] 0 0
Mater Hospital; Cancer Services - South Brisbane
Recruitment hospital [5] 0 0
Cabrini Medical Centre; Oncology - Malvern
Recruitment hospital [6] 0 0
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit - Bull Creek
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Wentworthville
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6149 - Bull Creek
Recruitment outside Australia
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Taipei
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Turkey
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Ankara
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Diyarbakir
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Istanbul
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Izmir
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Sakarya
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Ukraine
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KIEV Governorate
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kiev
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Lutsk
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Lviv
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Cardiff
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Coventry
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Glasgow
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London
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Plymouth
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Stoke on Trent
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03337724
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID: CO40016 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03337724