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JOURNAL ONKOLOGIE – STUDIE
EPIK-B3

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation

Rekrutierend

NCT-Nummer:
NCT04251533

Studienbeginn:
Juni 2020

Letztes Update:
27.05.2021

Wirkstoff:
Alpelisib, Placebo, Nab-Paclitaxel

Indikation (Clinical Trials):
Triple Negative Breast Neoplasms, Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 148)

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88212 Ravensburg
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23563 Luebeck
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13581 Berlin
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53111 Bonn
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01307 Dresden
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91054 Erlangen
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20357 Hamburg
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69120 Heidelberg
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04103 Leipzig
(Sachsen)
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18059 Rostock
(Mecklenburg-Vorpommern)
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72076 Tübingen
(Baden-Württemberg)
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89081 Ulm
(Baden-Württemberg)
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97080 Wuerzburg
(Bayern)
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University of California at Los Angeles Santa Monica Location
90095 Los Angeles
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Ansprechpartner:
Monica Rocha
Phone: +1 310 582 4069
E-Mail: mprocha@mednet.ucla.edu
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Cancer Care Associates Medical Group Center
90277 Redondo Beach
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Florida Cancer Specialists Dept of Oncology (2)
33901 Fort Myers
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Ansprechpartner:
Michele Hartzer
Phone: 727-216-1143
E-Mail: michele.hartzer@flcancer.com
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Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd
46815 Fort Wayne
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Ansprechpartner:
Raven Carter
Phone: 317-436-0800
E-Mail: raven.carter@fwmoh.com
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University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2
66160 Kansas City
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Ansprechpartner:
Jecinta Scott
Phone: 913-588-2566
E-Mail: jscott11@kumc.edu
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Research Medical Center HCA Midwest Division
64132 Kansas City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Molly Schroeder
Phone: 816-276-4700
E-Mail: molly.schroeder@hcamidwest.com
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Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
89109 Las Vegas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Krissy Gunn
Phone: 702-952-3426
E-Mail: krossy.gunn@usoncology.com
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Chattanooga Oncology and Hematology Assoicates, PC Tennessee Oncology Chattanooga
37404 Chattanooga
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Tara Gray
Phone: 423-698-1844
E-Mail: tara.gray@usoncology.com
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Texas Oncology Texas Oncology - Denton
75246 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nieves Contreras Alcantera
Phone: +1 940 382 1022
E-Mail: Nieves.ContrerasAlcantara@usoncology.com
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Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio
78229 San Antonio
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Alice Bock
Phone: 210-424-2610
E-Mail: Alice.Bock@usoncology.com
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Novartis Investigative Site
3000 Melbourne
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6150 Murdoch
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6009 Nedlands
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6020 Innsbruck
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95070-560 Caxias do Sul
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14784 400 Barretos
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01317-002 Sao Paulo
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03102-002 Sao Paulo
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110001 Bogota
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92210 Saint-Cloud
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49055 Angers Cedex 02
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25030 Besancon Cedex
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63011 Clermont-Ferrand
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30029 Nimes Cedex 9
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75475 Paris Cedex 10
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44805 Saint-Herblain Cédex
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94800 Villejuif Cedex
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6000 Kecskemet
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H 2800 Tatabanya
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121 001 Faridabad
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500034 Hyderabad
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500082 Hyderabad
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84101 Be'er Sheva
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52621 Ramat Gan
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6423906 Tel Aviv
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85028 Rionero in Vulture
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03080 Seoul
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05505 Seoul
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06351 Seoul
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46050 Petaling Jaya
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59100 Kuala Lumpur
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163045 Arkhangelsk
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454048 Chelyabinsk
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117997 Moscow
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123056 Moscow
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143423 Moscow
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196603 Pushkin Saint Petersburg
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812 50 Bratislava
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041 91 Kosice
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Studien-Informationen

Brief Summary:

The purpose of this study is to determine whether treatment with alpelisib in combination

with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast

cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without

PIK3CA mutation (Study Parts B1 and B2)

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent

and not amenable to curative therapy, or metastatic (stage IV)) TNBC

- Subject has either a measurable disease per RECIST 1.1 criteria or, if no measurable

disease is present, then at least one predominantly lytic bone lesion or mixed

lytic-blastic bone lesion with identifiable soft tissue component (that can be

evaluated by CT/MRI) must be present Part B1: patients must have measurable disease

- Subject has adequate tumor tissue to identify the PIK3CA mutation status (either

carrying a mutation or without a mutation) and the PTEN loss status; both of which

will determine whether the subject can be allocated to Part A - PIK3CA mutation

regardless of PTEN status; or to Part B - PTEN loss without a PIK3CA mutation

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Subject has received no more than one line of therapy for metastatic disease.

- Subject has adequate bone marrow and organ function

Exclusion Criteria:

- Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor

- Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their

excipients

- Subject has not recovered from all toxicities related to prior anticancer therapies to

NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia

- Subject has central nervous system (CNS) involvement

- Subject with an established diagnosis of diabetes mellitus type I or uncontrolled type

II based on Fasting Plasma Glucose and HbA1c

- Subject has impairment of gastrointestinal (GI) function or GI disease that may

significantly alter the absorption of the study drugs (e.g., ulcerative diseases,

uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel

resection) based on investigator discretion

- Subject has a history of acute pancreatitis within 1 year of screening or past medical

history of chronic pancreatitis

- Subject has currently documented pneumonitis/interstitial lung disease

- Subject has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome

(SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with

Eosinophilia and Systemic Syndrome (DRESS)

- Subject with unresolved osteonecrosis of the jaw

Other protocol-defined inclusion/exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Progression-free Survival (PFS) Per Investigator Assessment in Study part A (Time Frame - Once approximately 192 PFS events in Study Part A had been observed, up to 35 months):
PFS, defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

2. Progression-free Survival (PFS) Per Investigator Assessment in Study part B2 (Time Frame - Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months):
PFS, defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

3. Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in study Part B1 (Time Frame - Up to 6 months):
ORR is defined as the proportion of subjects with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1

Secondary outcome:

1. Overall Survival (OS) in Study Part A (Time Frame - Up to 66 months):
OS is defined as the time from date of randomization to date of death due to any cause

2. Overall Survival (OS) in Study Part B2 (Time Frame - Up to 41 months):
OS is defined as the time from date of randomization to date of death due to any cause

3. Overall response rate (ORR) with confirmed response in Study Part A (Time Frame - Up to 35 months):
ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

4. Overall response rate (ORR) with confirmed response in Study Part B2 (Time Frame - Up to 22 months):
ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

5. Clinical benefit rate (CBR) with confirmed response in Study Part A (Time Frame - Up to 35 months):
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1

6. Clinical benefit rate (CBR) with confirmed response in Study Part B1 (Time Frame - Up to 6 months):
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1

7. Clinical benefit rate (CBR) with confirmed response in Study Part B2 (Time Frame - Up to 22 months):
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1

8. Time to response (TTR) in Study Part A (Time Frame - Up to 35 months):
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1

9. Time to response (TTR) in Study Part B1 (Time Frame - Up to 6 months):
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1

10. Time to response (TTR) in Study Part B2 (Time Frame - Up to 22 months):
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1

11. Duration of Response (DOR) with confirmed response in Study Part A (Time Frame - Up to 35 months):
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer

12. Duration of Response (DOR) with confirmed response in Study Part B1 (Time Frame - Up to 6 months):
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer

13. Duration of Response (DOR) with confirmed response in Study Part B2 (Time Frame - Up to 22 months):
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer

14. Overall Survival (OS) in Study Part B1 (Time Frame - Up to 6 months):
OS is defined as the time from date of enrolment to date of death due to any cause

15. Progression-free Survival (PFS) Per Investigator Assessment in Study part B1 (Time Frame - Up to 6 months):
PFS, defined as time from the date of enrolment to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

16. Plasma concentrations of alpelisib - Part A (Time Frame - Up to 35 months):
Summary statistics of plasma alpelisib concentrations by time point in study Part A

17. Plasma concentrations of alpelisib - Part B1 (Time Frame - Up to 6 months):
Summary statistics of plasma alpelisib concentrations by time point in study Part B1

18. Plasma concentrations of alpelisib -Part B2 (Time Frame - up to 22 months):
Summary statistics of plasma alpelisib concentrations by time point in study Part B2

19. Plasma concentrations of paclitaxel - Part A (Time Frame - Up to 35 months):
Summary statistics of plasma paclitaxel concentrations by time point in study Part A

20. Plasma concentrations of paclitaxel - Part B1 (Time Frame - up to 6 months):
Summary statistics of plasma paclitaxel concentrations by time point in study Part B1

21. Change from baseline in the global health status/Quality of life (QoL) scale score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) in study Part A (Time Frame - Up to 35 months):
Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment

22. Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in study Part B2 (Time Frame - Up to 22 months):
Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment

23. Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part A (Time Frame - Up to 35 months):
Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems

24. Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part B2 (Time Frame - Up to 22 months):
Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems

25. PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part A (Time Frame - Up to 35 months):
PFS in patients with PIK3CA mutation as measured in ctDNA

26. PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part B2 (Time Frame - Up to 22 months):
PFS in patients with PIK3CA mutation as measured in ctDNA

27. Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline in Study Part A (Time Frame - Up to 35 months):
Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause

28. Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2 (Time Frame - Up to 22 months):
Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause

Studien-Arme

  • Experimental: alpelisib + nab-paclitaxel
    Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Single arm Open label in Study Part B1
  • Placebo Comparator: placebo + nab-paclitaxel
    Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Not applicable in Study Part B1

Geprüfte Regime

  • alpelisib (BYL719):
    300 mg orally once per day (QD)
  • placebo (alpelisib matching placebo):
    300 mg orally once per day (QD)
  • nab-paclitaxel (abraxane):
    100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle

Quelle: ClinicalTrials.gov


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