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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04546009




Registration number
NCT04546009
Ethics application status
Date submitted
8/09/2020
Date registered
11/09/2020

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Scientific title
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2020-000119-66
Secondary ID [2] 0 0
BO41843
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic 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 - Giredestrant-matched Placebo
Treatment: Drugs - Letrozole
Treatment: Drugs - Letrozole-matched Placebo
Treatment: Drugs - Palbociclib
Treatment: Drugs - LHRH Agonist

Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib -

Active comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib -


Treatment: Drugs: Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Giredestrant-matched Placebo
Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Letrozole
Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Letrozole-matched Placebo
Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

Treatment: Drugs: Palbociclib
Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

Treatment: Drugs: LHRH Agonist
Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization to death from any cause (up to 78 months)
Secondary outcome [2] 0 0
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Timepoint [2] 0 0
From randomization until disease progression or death (up to 78 months)
Secondary outcome [3] 0 0
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Timepoint [3] 0 0
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)
Secondary outcome [4] 0 0
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Timepoint [4] 0 0
From randomization until disease progression or death (up to 78 months)
Secondary outcome [5] 0 0
Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented =2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire
Timepoint [5] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [6] 0 0
Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented =10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score
Timepoint [6] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [7] 0 0
Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score
Timepoint [7] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [8] 0 0
Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score
Timepoint [8] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [9] 0 0
Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score
Timepoint [9] 0 0
From Baseline until treatment discontinuation (up to 78 months)
Secondary outcome [10] 0 0
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Timepoint [10] 0 0
From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)
Secondary outcome [11] 0 0
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Timepoint [11] 0 0
Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)
Secondary outcome [12] 0 0
Plasma Concentration of Giredestrant at Specified Timepoints
Timepoint [12] 0 0
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)
Secondary outcome [13] 0 0
Plasma Concentration of Palbociclib at Specified Timepoints
Timepoint [13] 0 0
Days 1 and 15 of Cycle 1 (1 cycle is 28 days)

Eligibility
Key inclusion criteria
* For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
* No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
* Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
* Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
* Prior treatment with a selective estrogen receptor degrader (SERD)
* Treatment with any investigational therapy within 28 days prior to study treatment
* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
* Pregnant or breastfeeding

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/03/2028
Actual
Sample size
Target
Accrual to date
Final
992
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre; Medical Oncology - Bedford Park
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-East Melbourne - Melbourne
Recruitment hospital [6] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Medical Oncology - Murdoch
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
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United States of America
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Massachusetts
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Missouri
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New York
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Bs As
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Rosario
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Argentina
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Vicente López
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Austria
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Salzburg
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Austria
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Steyr
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Hasselt
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BA
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GO
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Brazil
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PE
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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British Columbia
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Ontario
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Anyang City
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Herlev
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Vandoeuvre-les-nancy
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Berlin
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Chemnitz
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Dresden
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Essen
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Georgsmarienhütte
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Göttingen
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Hamburg
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Hannover
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Heidelberg
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Koblenz
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Langen
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Leipzig
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Mannheim
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München
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Ravensburg
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Trier
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Troisdorf
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Tübingen
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Greece
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Athens
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Greece
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Larissa
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Israel
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Petah Tiqwa
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Lazio
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Italy
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Lombardia
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Sicilia
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Osaka
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Tokyo
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Daegu
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Incheon
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Auckland
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Peru
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Lima
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Peru
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San Isidro
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Peru
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Trujillo
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Poland
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Gdansk
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Kharkiv Governorate
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Ivano-Frankivsk
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Kryvyi Rih
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Country [185] 0 0
United Kingdom
State/province [185] 0 0
Truro

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT04546009