Study Summary
This trial will compare two cancer treatments to see which is more effective in treating breast cancer that is Advanced or has Metastasized and is estrogen receptor and human epidermal growth factor receptor 2 positive.
Eligible Conditions
- Triple-Negative Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 23 Secondary · Reporting Duration: From randomization until death from any cause (up to 42 months)
Month 42
Number of Participants with Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study
Number of Participants with Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Number of Participants with at Least One Adverse Event, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)
Month 42
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Month 42
Time to Confirmed Deterioration (TTCD) in Health-Related Quality of Life (HRQoL), as Determined Using the EORTC Quality of Life-Core 30 (QLQ-C30) Questionnaire Linearly Transformed Global Health Status (GHS)/QoL Scale Score
Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference, as Determined Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire Linearly Transformed Pain Scale Score
Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF), as Determined Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire Linearly Transformed PF Scale Score
Time to Confirmed Deterioration (TTCD) in Role Functioning (RF), as Determined Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire Linearly Transformed RF Scale Score
Time to Confirmed Deterioration in Health-Related Quality of Life (HRQoL), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed Global Health Status (GHS)/QoL Scale Score, in the ESR1m Subpopulation and ITT Population
Pain
Pain
Linear Gramicidin
Time to Confirmed Deterioration in Role Functioning (RF), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed RF Scale Score, in the ESR1m Subpopulation and ITT Population
Month 42
Overall Survival
Overall Survival, in the ESR1m Subpopulation and ITT Population
Month 42
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Month 42
Investigator-Assessed Progression-Free Survival, in Subgroups Categorized Prospectively by Baseline Estrogen Receptor 1 (ESR1)-Mutation Status, as Measured by circulating-tumor DNA (ctDNA)
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Month 42
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Day 28
Plasma Concentration of Giredestrant at Specified Timepoints
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Giredestrant + Palbociclib
41%Neutropenia
23%Neutrophil count decreased
22%Asthenia
14%Nausea
14%Hot flush
13%Leukopenia
13%White blood cell count decreased
11%Anaemia
11%Arthralgia
9%Fatigue
8%Mucosal inflammation
7%Diarrhoea
5%Vomiting
5%Alopecia
5%Rash
4%Headache
3%Constipation
2%Procedural pain
1%Myocardial infarction
1%Pyrexia
1%Alanine aminotransferase increased
1%Aspartate aminotransferase increased
1%Uterine perforation
1%COVID-19
1%Hip fracture
Trial Design
2 Treatment Groups
Exemestane plus Everolimus
1 of 2
Giredestrant plus Everolimus
1 of 2
Active Control
Experimental Treatment
320 Total Participants · 2 Treatment Groups
Primary Treatment: Giredestrant · No Placebo Group · Phase 3
Giredestrant plus EverolimusExperimental Group · 4 Interventions: Giredestrant, Everolimus, Dexamethasone Mouth Rinse, LHRH Agonist · Intervention Types: Drug, Drug, Drug, Drug
Exemestane plus EverolimusActiveComparator Group · 4 Interventions: Everolimus, Dexamethasone Mouth Rinse, Exemestane, LHRH Agonist · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Giredestrant
2019
Completed Phase 2
~300
Everolimus
2010
Completed Phase 4
~1500
LHRH Agonist
2013
Completed Phase 2
~130
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization until death from any cause (up to 42 months)
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,497 Previous Clinical Trials
564,359 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,149 Previous Clinical Trials
875,916 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally.
The blood sample must be collected from a site other than the site of the tumor
Unbiased ResultsWe believe in providing patients with all the options.
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Conditions
Cancer Related
Treatments