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postMONARCH: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05169567
Collaborator
(none)
350
Enrollment
143
Locations
2
Arms
47.2
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
Actual Study Start Date :
Mar 11, 2022
Anticipated Primary Completion Date :
Aug 4, 2023
Anticipated Study Completion Date :
Feb 16, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Abemaciclib plus Fulvestrant

Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).

Drug: Abemaciclib
Administered orally.

Drug: Fulvestrant
Administered IM.
Active Comparator: Arm B: Placebo plus Fulvestrant

Placebo administered orally in combination with fulvestrant administered IM.

Drug: Fulvestrant
Administered IM.

Drug: Placebo
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Progression-Free Survival (PFS) [Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)]

    Investigator assessment

Secondary Outcome Measures

  1. Overall Survival (OS) [Randomization until death from any cause (estimated as up to 5 years)]

    OS

  2. PFS [Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)]

    Blinded independent review

  3. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [Randomization until measured progressive disease (estimated as up to 1 year)]

    ORR

  4. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [Randomization until measured progressive disease (estimated as up to 1 year)]

    CBR

  5. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD) [Randomization until measured progressive disease (estimated as up to 1 year)]

    DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD

  6. Duration of Response (DoR) [Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)]

    DoR

  7. Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [Randomization through Follow-up (estimated as up to 3 years)]

    The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

  8. Time to Deterioration in Physical Function [Randomization through Follow-up (estimated as up to 3 years)]

    Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.

  9. Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib [Day 1 of Cycle 3 (Cycle = 28 days)]

    PK: Mean Steady State Concentrations of Abemaciclib

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer

  • Have radiologic evidence of disease progression or recurrence either

  • On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or

  • On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer

  • Must be deemed appropriate for treatment with ET

  • If female, have a postmenopausal status by natural or surgical means

  • Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)

  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)

  • Have adequate renal, hematologic, and hepatic organ function

  • Must be able to swallow capsules/tablets

Exclusion Criteria:

  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis

  • Have symptomatic or untreated central nervous system metastasis

  • Have received any systemic therapy between disease recurrence/progression and study screening

  • Have received more than 1 line of therapy for advanced or metastatic disease.

  • Have received prior chemotherapy for metastatic breast cancer (MBC)

  • Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Hospital and Medical Center Phoenix Arizona United States 85004
2 Highlands Oncology Group Springdale Arkansas United States 72762
3 Providence Medical Foundation Fullerton California United States 92835
4 Cancer and Blood Specialty Clinic Los Alamitos California United States 90720
5 TRIO-US (Translational Research in Oncology-US) Los Angeles California United States 90024
6 Keck School of Medicine of USC Los Angeles California United States 90033
7 UCLA Hematology/Oncology - Parkside Santa Monica California United States 90404
8 Olive View-UCLA Medical Center Sylmar California United States 91342
9 Torrance Memorial Physician Network / Cancer Care Torrance California United States 90505
10 PIH Health Hematology Medical Oncology Whittier California United States 90602
11 Rocky Mountain Cancer Center Denver Colorado United States 80220
12 Florida Cancer Specialists Fort Myers Florida United States 33901
13 Millennium Oncology Research Clinic Hollywood Florida United States 33024
14 University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida United States 33136
15 Woodlands Medical Specialists Pensacola Florida United States 32503
16 Florida Cancer Specialists West Palm Beach Florida United States 33401
17 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
18 Northeast Georgia Medical Center Gainesville Georgia United States 30501
19 Central Georgia Cancer Care Macon Georgia United States 31201
20 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
21 Ingalls Memorial Hospital Harvey Illinois United States 60426
22 Franciscan St. Francis Health Indianapolis Indiana United States 46237
23 Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
24 Clinical Trials of SWLA Lake Charles Louisiana United States 70601
25 Central Maine Medical Center Lewiston Maine United States 04240
26 New England Cancer Specialists Scarborough Maine United States 04074
27 Mfsmc-Hjwci Baltimore Maryland United States 21237
28 Maryland Oncology Hematology, P.A. Clinton Maryland United States 20735
29 Massachusetts General Hospital Boston Massachusetts United States 02114
30 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
31 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
32 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
33 Massachusetts General Hospital Danvers Massachusetts United States 01923
34 Southcoast Centers for Cancer Care Fairhaven Massachusetts United States 02719
35 Dana-Farber Cancer Institute Methuen Massachusetts United States 01844
36 Vernon Cancer Center Pharmacy, Massachusetts General Cancer Center at Newton-Wellesley Newton Massachusetts United States 02462
37 Reliant Medical Group Worcester Massachusetts United States 01606
38 St. Vincent Frontier Cancer Center Billings Montana United States 59102
39 Dana-Farber Cancer Institute Londonderry New Hampshire United States 03053
40 University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico United States 87131
41 Oregon Health and Science University Portland Oregon United States 97239
42 Lifespan Cancer Institute Providence Rhode Island United States 02906
43 Tennessee Oncology Chattanooga-SCRI Chattanooga Tennessee United States 37404
44 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
45 Tennessee Oncology PLLC Nashville Tennessee United States 37203
46 Texas Oncology - Bedford Bedford Texas United States 76022
47 Parkland Health and Hospital System Dallas Texas United States 75235
48 UT Southwestern Medical Center Dallas Texas United States 75390-8884
49 Texas Oncology Denton Denton Texas United States 76201
50 Texas Oncology P.A. El Paso Texas United States 79902
51 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
52 Texas Oncology - McKinney McKinney Texas United States 75071
53 Texas Oncology-Plano East Plano Texas United States 75075
54 Texas Oncology-Plano West Plano Texas United States 75093
55 Mays Cancer Center San Antonio Texas United States 78229
56 US Oncology The Woodlands Texas United States 77380
57 Tyler Cancer Center Tyler Texas United States 75702
58 Intermountain Medical Center Murray Utah United States 84107
59 Intermountain Healthcare - St. George Saint George Utah United States 84770
60 The University of Vermont Medical Center Inc. Burlington Vermont United States 05401
61 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
62 Shenandoah Oncology, P.C. Winchester Virginia United States 22601
63 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina C1027AAP
64 Fundación Cenit Para La Investigación En Neurociencias Caba Ciudad Autónoma De Buenos Aire Argentina 1125
65 Instituto Médico Río Cuarto Río Cuarto Córdoba Argentina 5800
66 Centro Medico San Roque San Miguel de Tucumán Tucumán Argentina 4000
67 Fundación Respirar Buenos Aires Argentina C1426ABP
68 Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan San Juan Argentina 5400
69 Algemeen Ziekenhuis klina Brasschaat Antwerpen Belgium 2930
70 Jessa Ziekenhuis Hasselt Limburg Belgium 3500
71 CHU UCL Namur/Site Sainte Elisabeth Namur Belgium 5000
72 Multiscan Pardubice Pardubický Kraj Czechia 53203
73 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
74 Herlev and Gentofte Hospital Copenhagen Hovedstaden Denmark 2730
75 Regionshospitalet Gødstrup Herning Midtjyllan Denmark 7400
76 Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux Aquitaine France 33076
77 Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan Brest Bretagne France 29200
78 Hôpital privé du Confluent SAS Nantes Loire-Atlantique France 44277
79 CHD Vendee La Roche-sur-Yon Vendée France 85000
80 University Hospital of Patras Patras Achaḯa Greece 26504
81 Alexandra General Hospital of Athens Athens Attikí Greece 115 28
82 University General Hospital of Heraklion Heraklion Irakleío Greece 711 10
83 Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki Greece 546 45
84 Bacs-Kiskun Megyei Korhaz Kecskemét Bács-Kiskun Hungary 6000
85 Petz Aladar Egyetemi Oktato Korhaz Gyor Győr-Moson-Sopron Hungary 9024
86 Magyar Honvedseg Egeszsegugyi Kozpont Budapest Hungary 1062
87 Országos Onkológiai Intézet Budapest Hungary 1122
88 Soroka Medical Center Be'er Sheva HaDarom Israel 8400000
89 Meir Medical Center Kfar Saba HaMerkaz Israel 4428164
90 Rabin Medical Center Petah Tikva HaMerkaz Israel 4941492
91 Sheba Medical Center Ramat Gan HaMerkaz Israel 5265601
92 Sourasky Medical Center Tel Aviv Tell Abīb Israel 6423906
93 Hadassah Medical Center Jerusalem Yerushalayim Israel 9112001
94 Humanitas Istituto Clinico Catanese Misterbianco Catania Italy 95045
95 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Emilia-Romagna Italy 47014
96 P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale Udine Friuli-Venezia Giulia Italy 33100
97 Instituto Tumori Giovanni Paolo II Bari Italy 70124
98 Ospedale Misericordia di Grosseto Grosseto Italy 58100
99 Ospedale San Raffaele Milano Italy 20132
100 ASL Viterbo Ospedale Belcolle Viterbo Italy 01100
101 Seoul National University Bundang Hospital Seongnam Kyǒnggi-do Korea, Republic of 13620
102 Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 02841
103 Korea University Guro Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 8308
104 Kyungpook National University Chilgok Hospital Daegu Taegu-Kwangyǒkshi Korea, Republic of 41404
105 Centro de Investigacion en Artritis y Osteoporosis SC Mexicali Baja California Mexico 21200
106 COI Tijuana - Centro Oncológico Internacional Tijuana Baja California Mexico 22010
107 Centro Oncológico Internacional (COI) Guadalajara Jalisco Mexico 45640
108 Centro Regiomontano de Investigación Monterrey Nuevo León Mexico 64060
109 Oncologico Potosino, S.C. San Luis Potosi San Luis Potosí Mexico 78209
110 Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Wrocław Dolnośląskie Poland 53-413
111 Europejskie Centrum Zdrowia - Oddzial Onkologii Otwock Mazowieckie Poland 05-400
112 Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego Opole Opolskie Poland 45-060
113 Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Łódzkie Poland
114 CHUAC-Hospital Teresa Herrera A Coruña A Coruña [La Coruña] Spain 15006
115 Hospital Universitari Son Espases Palma Balears [Baleares] Spain 07120
116 Parc de Salut Mar - Hospital del Mar Barcelona Barcelona [Barcelona] Spain 08003
117 Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña] Spain 08036
118 Hospital General Universitario Gregorio Marañon Madrid Madrid, Comunidad De Spain 28009
119 Hospital Clínico Universitario Virgen de la Arrixaca El Palmar, Murcia Murcia, Región De Spain 30120
120 H.R.U Málaga - Hospital Materno-infantil Malaga Málaga Spain 29011
121 Complejo Hospitalario de Navarra Pamplona Navarra Spain 31009
122 Hospital Universitari Sant Joan de Reus Reus Tarragona [Tarragona] Spain 43204
123 Hospital Universitario Doctor Peset Valencia Valenciana, Comunitat Spain 46017
124 Hospital Infanta Cristina Badajoz Spain 06006
125 Hospital Universitario de Toledo Toledo Spain 45007
126 Sjukhuset I Gävle Gävle Gävleborgs Län [se-21] Sweden 803 24
127 Karolinska Universitetssjukhuset Solna Stockholm Stockholms Län [se-01] Sweden 171 76
128 Universitetssjukhuset Örebro Örebro Örebro Län [se-18] Sweden 701 85
129 Chi Mei Medical Center Tainan City Tainan Taiwan 71004
130 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
131 Taipei Tzu Chi General Hospital New Taipei City Taiwan 231
132 Mackay Memorial Hospital Taipei Taiwan 10449
133 Taipei Veterans General Hospital Taipei Taiwan 11217
134 Chang Gung Medical Foundation-Linkou Branch Taoyuan Taiwan 333
135 Izmir Medical Park Hospital Izmir, Karsiyaka İzmir Turkey 009035575
136 Necmettin Erbakan Meram Medical Fac. Meram Konya Turkey 42080
137 Adana City Hospital Adana Turkey 01370
138 Ankara Gülhane Eitim ve Aratrma Hastanesi Ankara Turkey 06010
139 Memorial Ankara Hastanesi Ankara Turkey 06520
140 Dicle Üniversitesi Diyarbakir Turkey 21200
141 Trakya University Edirne Turkey 22030
142 TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul Turkey 34722
143 Inonu Universitesi Turgut Ozal Tıp Merkezi Malatya Turkey 44280

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05169567
Other Study ID Numbers:
  • 18238
  • I3Y-MC-JPEF
  • 2021-002301-10
First Posted:
Dec 27, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Fulvestrant

Study Results

No Results Posted as of Aug 19, 2022