Study Summary
This trial is testing new treatments for breast cancer that has progressed despite other treatments. It is open to people with different types of breast cancer who have tried different kinds of treatment already.
Eligible Conditions
- Triple-Positive Breast Cancer
Treatment Effectiveness
Study Objectives
13 Primary · 5 Secondary · Reporting Duration: From Baseline until disease progression (up to 6 years)
Day 30
Serum Concentration of Pertuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Serum Concentration of Trastuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Day 28
Blood Concentration of Everolimus at Specified Timepoints
Plasma Concentration of Ribociclib at Specified Timepoints
Day 28
Plasma Concentration of Inavolisib at Specified Timepoints
Plasma Concentration of Ipatasertib at Specified Timepoints
Day 30
Plasma Concentration of Abemaciclib at Specified Timepoints
Plasma Concentration of Palbociclib at Specified Timepoints
Day 30
Plasma Concentration of Giredestrant at Specified Timepoints
Plasma Concentration of Samuraciclib at Specified Timepoints
Day 30
Serum Concentration of Atezolizumab at Specified Timepoints
Year 6
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)
Year 6
Clinical Benefit Rate, Defined as the Percentage of Participants with Stable Disease for ≥24 Weeks or with Confirmed Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Disease Control Rate, Defined as the Percentage of Participants with Stable Disease for ≥12 Weeks or a Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Year 6
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Year 6
Overall Survival
Year 6
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
Trial Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
13 Treatment Groups
Giredestrant Monotherapy
1 of 13
Cohort 2: Giredestrant + PH FDC SC
1 of 13
Cohort 1: Giredestrant Monotherapy
1 of 13
Cohort 1: Giredestrant + Everolimus
1 of 13
Cohort 1: Giredestrant + Atezolizumab
1 of 13
Cohort 1: Giredestrant + Abemaciclib
1 of 13
Cohort 1: Giredestrant + Ipatasertib
1 of 13
Cohort 1: Giredestrant + Inavolisib
1 of 13
Cohort 1: Giredestrant + Ribociclib
1 of 13
Cohort 2: Giredestrant + PH FDC SC + Abemaciclib
1 of 13
Cohort 1: Giredestrant + Samuraciclib
1 of 13
Cohort 1: Giredestrant + Abemaciclib + Atezolizumab
1 of 13
Cohort 2: Giredestrant + PH FDC SC + Palbociclib
1 of 13
Active Control
Experimental Treatment
510 Total Participants · 13 Treatment Groups
Primary Treatment: Palbociclib · No Placebo Group · Phase 1 & 2
Cohort 1: Giredestrant + EverolimusExperimental Group · 2 Interventions: Everolimus, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + AtezolizumabExperimental Group · 2 Interventions: Atezolizumab, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + AbemaciclibExperimental Group · 2 Interventions: Abemaciclib, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + IpatasertibExperimental Group · 2 Interventions: Ipatasertib, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + InavolisibExperimental Group · 2 Interventions: Inavolisib, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + RibociclibExperimental Group · 2 Interventions: Ribociclib, Giredestrant · Intervention Types: Drug, Drug
Cohort 2: Giredestrant + PH FDC SC + AbemaciclibExperimental Group · 3 Interventions: PH FDC SC, Abemaciclib, Giredestrant · Intervention Types: Drug, Drug, Drug
Cohort 1: Giredestrant + SamuraciclibExperimental Group · 2 Interventions: Samuraciclib, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant + Abemaciclib + AtezolizumabExperimental Group · 3 Interventions: Atezolizumab, Abemaciclib, Giredestrant · Intervention Types: Drug, Drug, Drug
Cohort 2: Giredestrant + PH FDC SC + PalbociclibExperimental Group · 3 Interventions: Palbociclib, PH FDC SC, Giredestrant · Intervention Types: Drug, Drug, Drug
Giredestrant MonotherapyActiveComparator Group · 1 Intervention: Giredestrant Monotherapy · Intervention Types:
Cohort 2: Giredestrant + PH FDC SCActiveComparator Group · 2 Interventions: PH FDC SC, Giredestrant · Intervention Types: Drug, Drug
Cohort 1: Giredestrant Monotherapy
Drug
ActiveComparator Group · 1 Intervention: Giredestrant · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Atezolizumab
2016
Completed Phase 3
~6280
Ribociclib
FDA approved
Everolimus
FDA approved
Ipatasertib
Not yet FDA approved
Abemaciclib
FDA approved
Giredestrant
2019
Completed Phase 2
~300
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline until disease progression (up to 6 years)
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,388 Previous Clinical Trials
1,072,706 Total Patients Enrolled
156 Trials studying Breast Cancer
90,188 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,169 Previous Clinical Trials
880,560 Total Patients Enrolled
135 Trials studying Breast Cancer
71,030 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For cohort 2, you need to provide a tumor sample that can be tested for biomarkers.
It is okay if you have received fulvestrant therapy in the past.
You have previously received treatment for HER2-positive cancer that did not work.
You are expected to live for at least three more months.
Frequently Asked Questions
What has been previously discovered about Palbociclib through research?
"Palbociclib is being trialled in 589 different medical studies, 121 of which are in Phase 3. Although a significant number of these trials for Palbociclib are based in Seattle, Washington, there are 33,161 total locations running clinical trials for Palbociclib." - Anonymous Online Contributor
Unverified Answer
Can people with the correct medical qualifications join this trial at this time?
"That is correct. As advertised on clinicaltrials.gov, this research is recruiting patients. The trial was first posted on June 20th, 2021 and was updated on October 17th, 2022. The study is looking for a total of 510 patients from 12 different research sites." - Anonymous Online Contributor
Unverified Answer
What are some off-label indications for Palbociclib?
"Palbociclib is most often used in treating kidney transplants. It can also be useful in managing waldenstrom macroglobulinemia, lung, and advanced carcinoid tumor." - Anonymous Online Contributor
Unverified Answer
Are different hospitals participating in this research project?
"Currently, patients are being recruited from 12 different medical centres including University of Minnesota Medical Center (UMMC), West Cancer Center, and City of Hope." - Anonymous Online Contributor
Unverified Answer