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A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer



Mai 2021

Letztes Update:

Abemaciclib, Standard Adjuvant ET, Placebo

Indikation (Clinical Trials):
Breast Neoplasms


Erwachsene (18+)

Phase 3

Eli Lilly and Company



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)
Study Director
Eli Lilly and Company


There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559
» Kontaktdaten anzeigen

(3 von 522)

Gynäkologisches Krebszentrum Agaplesion Markus Krankenhaus Frankfurt
Wilhelm-Epstein-Straße 4
60431 Frankfurt am Main
DeutschlandRekrutierend» Google-Maps

Phone: 496995332228
» Ansprechpartner anzeigen
Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
DeutschlandNoch nicht rekrutierend» Google-Maps

Phone: 004945150041700
» Ansprechpartner anzeigen
Greater Baltimore Medical Center
21204 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Texas Oncology - Methodist Charlton Cancer Center
75237 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Texas Oncology-Memorial City
77024 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Clinica Onco Star
04543-000 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Afflilated Hospital of Bengbu Medical College
233004 Bengbu
ChinaNoch nicht rekrutierend» Google-Maps
Anhui Provincial Hospital
230001 Hefei
ChinaNoch nicht rekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
510080 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Cangzhou Central Hospital
061014 Cangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Hubei Cancer Hospital
430079 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Xiangya Hospital Central South University
410008 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
Inner Mongolia People's Hospital
010017 Hohhot
ChinaNoch nicht rekrutierend» Google-Maps
Jilin Cancer Hospital
130012 Chang Chun
ChinaNoch nicht rekrutierend» Google-Maps
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
210000 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
The Third Hospital of Nanchang
330009 Nanchang
ChinaNoch nicht rekrutierend» Google-Maps
Dalian University - The Affiliated Zhongshan Hospital
116001 Dalian
ChinaNoch nicht rekrutierend» Google-Maps
Linyi Cancer Hospital
276000 Linyi
ChinaNoch nicht rekrutierend» Google-Maps
Zhongshan Hospital, Fudan University
200032 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Tang Du Hospital, The Second Teaching Hospital of FMMU
710038 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University General Hospital
300052 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
First Affiliated Hosp of College of Med, Zhejiang University
310003 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First People's Hospital of Hangzhou
310006 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
The Second Hospital of Jilin University
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University Cancer Institute & Hospital
300060 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'An
ChinaNoch nicht rekrutierend» Google-Maps
Alle anzeigen


Brief Summary:

The main purpose of this study is to measure how well abemaciclib works in participants with

early breast cancer who are taking hormone therapy after surgery. Participants must have

breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive

(HER2+). Your participation could last up to 10 years depending on how you and your tumor



Inclusion Criteria:

- Have confirmed HR+, HER2+ in initial diagnostic tissue, early invasive breast cancer

without evidence of disease recurrence or distant metastases

- Have undergone definitive surgery of the primary breast tumor(s)

- Have tumor tissue from breast (preferred) or lymph node

- Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or

adjuvant setting per standard of care therapy

- Have completed approximately nine months to one year of standard HER2-targeted therapy

without evidence of disease recurrence (neoadjuvant/adjuvant combined duration)

- Have received one of the following eligible HER2-targeted adjuvant regimens AND be

randomized within 12 weeks of completing the regimen:

- For participants treated with neoadjuvant therapy (chemotherapy administered with

HER2-targeted therapy): Single agent adjuvant ado-trastuzumab emtansine or

- For participants not treated with neoadjuvant therapy: Adjuvant pertuzumab with


- Have high risk disease, defined by one of the following:

- For participants treated with neoadjuvant therapy (as defined above):

Pathologically detected axillary nodal disease in the surgical specimen

- For participants not treated with neoadjuvant therapy: Axillary node positive

disease meeting one of the following criteria:

- Pathological tumor involvement in greater than or equal to (≥) four

ipsilateral axillary lymph nodes OR

- Pathological tumor involvement in one to three ipsilateral axillary lymph

node(s) and at least 1 of the following criteria:

- Histological Grade 3

- Primary invasive tumor size ≥5 centimeters determined pathologically

Exclusion Criteria:

- Have breast cancer with any of the following features:

- Disease recurrence or distant metastatic disease (including contralateral

axillary lymph nodes)

- Lymph node-negative status

- Pathological complete response from any prior systemic treatments for early

breast cancer

- Inflammatory breast cancer

- Have other medical conditions including:

- Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS]

treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by

locoregional therapy at any time)

- Other cancer being treated and/or not in complete remission within the last 5

years (Exceptions: Appropriately treated non-melanomatous skin cancer or

carcinoma in situ of cervix, bladder, or colon)

- Females who are pregnant or lactating

- History of venous thromboembolism

- Other serious medical conditions

- Have previously received treatment with:

- Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor

- Prior adjuvant treatment with immunotherapy, tucatinib, neratinib,

investigational HER2 directed therapy, or trastuzumab deruxtecan for treatment of

breast cancer

- Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for

breast cancer prevention (without diagnosis of breast cancer)

- Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard

of care therapy for their breast cancer at study enrollment


Primary outcome:

1. Invasive Disease Free Survival (IDFS) (Time Frame - Randomization to Recurrence or Death from Any Cause (up to 10 Years)):
IDFS as defined by the STEEP System

Secondary outcome:

1. Overall Survival (OS) (Time Frame - Randomization to Death from Any Cause (up to 10 Years)):

2. Distant Relapse-Free Survival (DRFS) (Time Frame - Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)):

3. Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence (Time Frame - Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)):
Percentage of Participants with CNS Metastases as First Site of Disease Recurrence

4. Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score (Time Frame - Cycle 1 up to end of Year 4):
EORTC QLQ-C30 is 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.

5. Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score (Time Frame - Cycle 1 up to end of Year 4):
The EQ-5D is a self-administered questionnaire that participants complete to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 5 (no problem, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively). These combinations of attributes were converted into a weighted Health State Index score; the possible values for the Health State Index score range from less than 0 (0 equals health state of "dead"; severe problems in all 5 dimensions) to 1.0 (full health; no problem in any dimension). Higher score indicates better health state.

6. Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib (Time Frame - Day 1 of Cycles 1-3 (Cycle = 28 days)):
PK: Mean Steady State Concentrations of Abemaciclib


  • Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET)
    Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
  • Active Comparator: Placebo + ET
    Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Geprüfte Regime

  • Abemaciclib (LY2835219):
    Administered orally.
  • Standard Adjuvant ET:
    Administered according to label instructions.
  • Placebo:
    Administered orally.


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