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A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)

10 stycznia 2020 zaktualizowane przez: Eli Lilly and Company

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

132

Faza

  • Faza 2

Rozszerzony dostęp

Do dyspozycji poza badaniem klinicznym. Zobacz rozwinięty rekord dostępu.

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Belgia
      • Brussel, Belgia, 1000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Charleroi, Belgia, 6000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Leuven, Belgia, 3000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Liège, Belgia, 4000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Francja
      • Dijon, Francja, 21034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Paris, Francja, 75248
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Hiszpania
      • Barcelona, Hiszpania, 08035
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid, Hiszpania, 28007
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia, Hiszpania, 46015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Stany Zjednoczone
    • Arizona
      • Sedona, Arizona, Stany Zjednoczone, 86336
        • Northern Arizona Hematology & Oncology Associates
      • Tucson, Arizona, Stany Zjednoczone, 85715
        • Arizona Clinical Research Center
      • Tucson, Arizona, Stany Zjednoczone, 85704
        • HOPE Hematology Oncology Physicians and Extenders
    • California
      • San Francisco, California, Stany Zjednoczone, 94115
        • Univ of California San Francisco
      • Santa Barbara, California, Stany Zjednoczone, 93105
        • Sansum Medical Research Foundation
    • Colorado
      • Denver, Colorado, Stany Zjednoczone, 80220
        • Rocky Mountain Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20010
        • Washington Hospital Center
    • Florida
      • Fort Myers, Florida, Stany Zjednoczone, 33916
        • Florida Cancer Specialists
      • Miami, Florida, Stany Zjednoczone, 33176
        • Advanced Medical Specialties
      • Saint Petersburg, Florida, Stany Zjednoczone, 33705
        • Florida Cancer Specialists
    • Maryland
      • Columbia, Maryland, Stany Zjednoczone, 21044
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Dana Farber Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55404
        • Minnesota Oncology/Hematology PA
    • New York
      • New York, New York, Stany Zjednoczone, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45242
        • Oncology Hematology Care Inc
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78731
        • Texas Oncology Cancer Center
      • Bedford, Texas, Stany Zjednoczone, 76022
        • Texas Oncology - Bedford
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, Stany Zjednoczone, 75231
        • Presbyterian Hospital Dallas
      • Fort Worth, Texas, Stany Zjednoczone, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, Stany Zjednoczone, 77024
        • Texas Oncology-Memorial City
      • Plano, Texas, Stany Zjednoczone, 75093
        • Texas Oncology-Plano West
      • Sherman, Texas, Stany Zjednoczone, 75090-0504
        • Texas Oncology-Sherman
      • The Woodlands, Texas, Stany Zjednoczone, 77380
        • US Oncology
      • Tyler, Texas, Stany Zjednoczone, 75702
        • Tyler Cancer Center
    • Washington
      • Vancouver, Washington, Stany Zjednoczone, 98684
        • Northwest Cancer Specialists PC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

Inclusion Criteria.

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
  • Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.

  • Prior treatment with at least 2 chemotherapy regimens:

    • At least 1 of these regimens must have been administered in the metastatic setting.
    • At least 1 of these regimens must have contained a taxane.
    • No more than 2 prior chemotherapy regimens in the metastatic setting.
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
  • Have discontinued all previous therapies for cancer.
  • Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

Exclusion Criteria:

  • Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
  • Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
  • Have had major surgery within 14 days of the initial dose of study drug.
  • Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Lek: Abemacyklib
Podawany doustnie
Inne nazwy:
  • LY2835219

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Ramy czasowe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS)
Ramy czasowe: From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
Duration of Response (DOR)
Ramy czasowe: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Progression Free Survival (PFS)
Ramy czasowe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
Ramy czasowe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
Ramy czasowe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
Ramy czasowe: Cycle 6 Day 1
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Cycle 6 Day 1
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
Ramy czasowe: Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
Ramy czasowe: Cycle 6 Day 1
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Cycle 6 Day 1

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 czerwca 2014

Zakończenie podstawowe (Rzeczywisty)

30 kwietnia 2016

Ukończenie studiów (Rzeczywisty)

22 października 2018

Daty rejestracji na studia

Pierwszy przesłany

31 marca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 marca 2014

Pierwszy wysłany (Oszacować)

3 kwietnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 stycznia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 stycznia 2020

Ostatnia weryfikacja

1 stycznia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 15419
  • I3Y-MC-JPBN (Inny identyfikator: Eli Lilly and Company)
  • 2013-005548-27 (Inny identyfikator: EudraCT Number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Ramy czasowe udostępniania IPD

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Kryteria dostępu do udostępniania IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • CSR

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak piersi z przerzutami

Badania kliniczne na Abemacyklib

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Kyrgyzstan

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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