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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06065748




Registration number
NCT06065748
Ethics application status
Date submitted
26/09/2023
Date registered
4/10/2023

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Scientific title
A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Secondary ID [1] 0 0
2022-502980-39-00
Secondary ID [2] 0 0
CO44657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Giredestrant
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Ribociclib
Treatment: Drugs - LHRH Agonist
Diagnosis / Prognosis - FoundationOne Liquid CDx Assay (F1LCDx)

Experimental: Giredestrant + Investigator's Choice of CDK4/6i - Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Active comparator: Fulvestrant + Investigator's Choice of CDK4/6i - Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.


Treatment: Drugs: Giredestrant
Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Abemaciclib
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Palbociclib
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: Ribociclib
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Treatment: Drugs: LHRH Agonist
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

Diagnosis / Prognosis: FoundationOne Liquid CDx Assay (F1LCDx)
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup
Timepoint [1] 0 0
From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
Primary outcome [2] 0 0
PFS in the Full Analysis Set (FAS) Population
Timepoint [2] 0 0
From randomization to first occurrence of PD or death (up to 5 years)
Secondary outcome [1] 0 0
PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup
Timepoint [1] 0 0
From randomization to first occurrence of PD or death (up to 5 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization until death from any cause (up to 5 years)
Secondary outcome [3] 0 0
Confirmed Objective Response Rate (cORR)
Timepoint [3] 0 0
From randomization until treatment discontinuation (up to 5 years)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
From the first occurrence of a documented objective response to PD or death (up to 5 years)
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
From randomization until treatment discontinuation (up to 5 years)
Secondary outcome [6] 0 0
Time to Chemotherapy
Timepoint [6] 0 0
From randomization until the start of chemotherapy or death (up to 5 years)
Secondary outcome [7] 0 0
Time to Confirmed Deterioration (TTCD) in Pain Severity
Timepoint [7] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [8] 0 0
TTCD in Pain Presence and Interference
Timepoint [8] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [9] 0 0
TTCD in Physical Functioning
Timepoint [9] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [10] 0 0
TTCD in Role Functioning
Timepoint [10] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [11] 0 0
TTCD in Global Health Status/Quality of Life
Timepoint [11] 0 0
From randomization until end of follow-up (up to 5 years)
Secondary outcome [12] 0 0
Incidence and Severity of Adverse Events
Timepoint [12] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [13] 0 0
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Timepoint [13] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [14] 0 0
Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study
Timepoint [14] 0 0
From Baseline until 28 days after the final dose of study treatment (up to 5 years)

Eligibility
Key inclusion criteria
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2028
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [2] 0 0
Nepean Hospital; Nepean Cancer Care Centre - Kingswood
Recruitment hospital [3] 0 0
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research - North Sydney
Recruitment hospital [4] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [5] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment hospital [6] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [7] 0 0
Barwon Health - Geelong
Recruitment hospital [8] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [9] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment postcode(s) [9] 0 0
3280 - Warrnambool
Recruitment outside Australia
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United States of America
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Alabama
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California
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Bangkok
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Lak Si
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Muang Chiang MAI Delivery Branch 3
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Thailand
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Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CO44657 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06065748