A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)
10 januari 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
132
Fas
- Fas 2
Utökad åtkomst
Tillgängligt utanför den kliniska prövningen.
Se utökad åtkomstpost.
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brussel, Belgien, 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.
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Charleroi, Belgien, 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.
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Leuven, Belgien, 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.
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Liège, Belgien, 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.
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Dijon, Frankrike, 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.
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Paris, Frankrike, 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.
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Arizona
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Sedona, Arizona, Förenta staterna, 86336
- Northern Arizona Hematology & Oncology Associates
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Tucson, Arizona, Förenta staterna, 85715
- Arizona Clinical Research Center
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Tucson, Arizona, Förenta staterna, 85704
- HOPE Hematology Oncology Physicians and Extenders
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California
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San Francisco, California, Förenta staterna, 94115
- Univ of California San Francisco
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Santa Barbara, California, Förenta staterna, 93105
- Sansum Medical Research Foundation
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain Cancer Center
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010
- Washington Hospital Center
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Florida
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Fort Myers, Florida, Förenta staterna, 33916
- Florida Cancer Specialists
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Miami, Florida, Förenta staterna, 33176
- Advanced Medical Specialties
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Saint Petersburg, Florida, Förenta staterna, 33705
- Florida Cancer Specialists
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Maryland
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Columbia, Maryland, Förenta staterna, 21044
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55404
- Minnesota Oncology/Hematology PA
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New York
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45242
- Oncology Hematology Care Inc
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Sarah Cannon Research Institute SCRI
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Texas
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Austin, Texas, Förenta staterna, 78731
- Texas Oncology Cancer Center
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Bedford, Texas, Förenta staterna, 76022
- Texas Oncology - Bedford
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Dallas, Texas, Förenta staterna, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Förenta staterna, 75231
- Presbyterian Hospital Dallas
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Fort Worth, Texas, Förenta staterna, 76104
- The Center for Cancer and Blood Disorders
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Houston, Texas, Förenta staterna, 77024
- Texas Oncology-Memorial City
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Plano, Texas, Förenta staterna, 75093
- Texas Oncology-Plano West
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Sherman, Texas, Förenta staterna, 75090-0504
- Texas Oncology-Sherman
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The Woodlands, Texas, Förenta staterna, 77380
- US Oncology
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Tyler, Texas, Förenta staterna, 75702
- Tyler Cancer Center
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Washington
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Vancouver, Washington, Förenta staterna, 98684
- Northwest Cancer Specialists PC
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Barcelona, Spanien, 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.
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Madrid, Spanien, 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.
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Valencia, Spanien, 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.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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Administreras oralt
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Tidsram: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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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.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Overall Survival (OS)
Tidsram: From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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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.
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From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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Duration of Response (DOR)
Tidsram: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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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.
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From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Progression Free Survival (PFS)
Tidsram: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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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.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
Tidsram: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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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.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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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)
Tidsram: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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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.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
Tidsram: Cycle 6 Day 1
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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).
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Cycle 6 Day 1
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Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
Tidsram: 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
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Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
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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
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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
Tidsram: Cycle 6 Day 1
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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.
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Cycle 6 Day 1
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 juni 2014
Primärt slutförande (Faktisk)
30 april 2016
Avslutad studie (Faktisk)
22 oktober 2018
Studieregistreringsdatum
Först inskickad
31 mars 2014
Först inskickad som uppfyllde QC-kriterierna
31 mars 2014
Första postat (Uppskatta)
3 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15419
- I3Y-MC-JPBN (Annan identifierare: Eli Lilly and Company)
- 2013-005548-27 (Annan identifierare: EudraCT Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .