Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05696626
Registration number
NCT05696626
Ethics application status
Date submitted
13/01/2023
Date registered
25/01/2023
Date last updated
18/06/2024
Titles & IDs
Public title
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Query!
Scientific title
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Query!
Secondary ID [1]
0
0
SMX 22-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ELAINEIII
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Lasofoxifene in combination with abemaciclib
Treatment: Drugs - Fulvestrant in combination with abemaciclib
Experimental: Treatment - Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Active comparator: Reference Therapy - Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Treatment: Drugs: Lasofoxifene in combination with abemaciclib
5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
Treatment: Drugs: Fulvestrant in combination with abemaciclib
Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression free survival (PFS)
Query!
Assessment method [1]
0
0
PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 or death due to any cause.
Query!
Timepoint [1]
0
0
Within approximately 3 years
Query!
Secondary outcome [1]
0
0
Objective response rate (ORR)
Query!
Assessment method [1]
0
0
ORR is defined as the percentage of subjects with measurable disease at baseline whose best overall response is either a confirmed CR or a confirmed PR according to RECIST 1.1.
Query!
Timepoint [1]
0
0
Within approximately 3 years
Query!
Secondary outcome [2]
0
0
Overall survival (OS)
Query!
Assessment method [2]
0
0
Overall survival is defined as time from the date of Visit 0 (Day 1) to death due to any cause.
Query!
Timepoint [2]
0
0
Within approximately 3 years
Query!
Secondary outcome [3]
0
0
Clinical benefit rate (CBR)
Query!
Assessment method [3]
0
0
CBR is defined as the percentage of subjects with best overall response of confirmed CR, confirmed PR, or stable disease (SD) with a duration of 24 weeks or longer according to RECIST 1.1. As used in this calculation, stable disease is defined as stable disease in those subjects with measurable disease plus nonPR/non progressive disease (PD) in subjects with non-measurable disease.
Query!
Timepoint [3]
0
0
Within approximately 3 years
Query!
Secondary outcome [4]
0
0
Duration of response (DoR) in subjects with an objective response
Query!
Assessment method [4]
0
0
DoR is from the date of first documented confirmed response (CR or PR) to the date of first documented progression of disease or death due to any cause, whichever is earlier.
Query!
Timepoint [4]
0
0
Within approximately 3 years
Query!
Secondary outcome [5]
0
0
Time to response (TTR) in subjects with an objective response
Query!
Assessment method [5]
0
0
TTR is from the date of randomization to the date of first documented confirmed response (CR or PR).
Query!
Timepoint [5]
0
0
Within approximately 3 years
Query!
Secondary outcome [6]
0
0
Time to cytotoxic chemotherapy
Query!
Assessment method [6]
0
0
From the date of randomization to the date of first documented use of cytotoxic chemotherapy.
Query!
Timepoint [6]
0
0
Within approximately 3 years
Query!
Secondary outcome [7]
0
0
Quality of Life (QoL) evaluated using the Functional Assessment of Cancer Therapy-Breast Cancer-Endocrine Subscale (FACT B-ES)
Query!
Assessment method [7]
0
0
Scale ranges from 'Not at all' to 'Very much'
Query!
Timepoint [7]
0
0
Within approximately 3 years
Query!
Secondary outcome [8]
0
0
Incidence of Adverse Events (AEs) and Serious AEs
Query!
Assessment method [8]
0
0
The type, severity (graded by Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]), course, duration, seriousness, and relationship to study treatment will be assessed at each visit
Query!
Timepoint [8]
0
0
Within approximately 3 years
Query!
Eligibility
Key inclusion criteria
1. Pre- or postmenopausal women or men.
2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease.
3. Histological or cytological confirmation of ER+/HER2 - disease
4. No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.
5. At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue.
6. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
7. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy.
8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
9. Adequate organ function
10. Able to swallow tablets
11. Brain metastases are allowed only if the following 4 parameters hold:
1. Asymptomatic,
2. Definitively treated (e.g., radiotherapy, surgery),
3. Not requiring steroids up to 4 weeks before study treatment initiation, AND
4. Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI).
12. Able to understand and voluntarily sign a written informed consent before any screening procedures.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Lymphangitic carcinomatosis involving the lung.
2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients
6. Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1).
7. Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)
8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of >480 msec.
9. History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia.
10. Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure [CHF] or prolonged immobilization).
11. On concomitant strong CYP3A4 inhibitors.
12. On strong and moderate CYP3A4 inducers.
13. Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.
14. Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment).
15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
16. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.
17. Positive serum pregnancy test (only if premenopausal).
18. Sexually active premenopausal women and men unwilling to use double-barrier contraception.
19. Women who are breast feeding
20. History of non-compliance to medical regimens.
21. Unwilling or unable to comply with the protocol.
22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/10/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2026
Query!
Actual
Query!
Sample size
Target
400
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Blacktown Hospital - Blacktown
Query!
Recruitment hospital [2]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [3]
0
0
Mater Misericordiae Ltd, South Brisbane - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
- Blacktown
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Dakota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Vermont
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Brussels
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Edegem
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Leuven
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Liège
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Namur
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Quebec
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Brno
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Hradec Králové
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Olomouc
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Praha 5
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Besançon
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Bordeaux
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
CAEN Cedex 05
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lille
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Lyon
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Marseille
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Poitiers
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Rouen
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Strasbourg
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Toulouse
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Dresden
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Ulm
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Budapest
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Haifa
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Jerusalem
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Petach Tikva
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Re?ovot
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Tel Aviv
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Tel HaShomer
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Aviano
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Meldola
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Milano
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Misterbianco
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Modena
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Napoli
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Parma
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Pavia
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Roma
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Verona
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Gyeonggi-do
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Hwasun
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Seoul
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Biala Podlaska
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Gdansk
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Gliwice
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Kielce
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Krakow
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Kraków
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Lublin
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Poznan
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Wieliszew
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Lódz
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Bucharest
Query!
Country [77]
0
0
Romania
Query!
State/province [77]
0
0
Cluj-Napoca
Query!
Country [78]
0
0
Romania
Query!
State/province [78]
0
0
Craiova
Query!
Country [79]
0
0
Romania
Query!
State/province [79]
0
0
Pitesti
Query!
Country [80]
0
0
Romania
Query!
State/province [80]
0
0
Timisoara
Query!
Country [81]
0
0
Singapore
Query!
State/province [81]
0
0
Singapore
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barcelona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Córdoba
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Madrid
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Málaga
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Pamplona
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Valencia
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
Changhua
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
Kaohsiung
Query!
Country [90]
0
0
Taiwan
Query!
State/province [90]
0
0
Tainan
Query!
Country [91]
0
0
Taiwan
Query!
State/province [91]
0
0
Taipei City
Query!
Country [92]
0
0
Taiwan
Query!
State/province [92]
0
0
Taipei
Query!
Country [93]
0
0
Taiwan
Query!
State/province [93]
0
0
Taoyuan City
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Edirne
Query!
Country [95]
0
0
Turkey
Query!
State/province [95]
0
0
Kocaeli
Query!
Country [96]
0
0
Turkey
Query!
State/province [96]
0
0
Ankara
Query!
Country [97]
0
0
Turkey
Query!
State/province [97]
0
0
Bursa
Query!
Country [98]
0
0
Turkey
Query!
State/province [98]
0
0
Cankaya
Query!
Country [99]
0
0
Turkey
Query!
State/province [99]
0
0
Istanbul
Query!
Country [100]
0
0
Turkey
Query!
State/province [100]
0
0
Izmir
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Isleworth
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Leeds
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Manchester
Query!
Country [104]
0
0
United Kingdom
Query!
State/province [104]
0
0
Nottingham
Query!
Country [105]
0
0
United Kingdom
Query!
State/province [105]
0
0
Preston
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sermonix Pharmaceuticals Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05696626
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Sermonix Pharmaceuticals Study Inquiry
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
614-864-4919
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05696626
Download to PDF