Your session is about to expire
← Back to Search
Cyclin-dependent kinase 4/6 inhibitor
Combination Therapy for Breast Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal status for women
Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until disease progression (up to 6 years)
Awards & highlights
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.
Who is the study for?
This trial is for postmenopausal women with advanced or metastatic ER-positive, HER2-negative breast cancer that worsened after CDK4/6 inhibitor treatment. It's also for those with ER-positive, HER2-positive breast cancer resistant to anti-HER2 therapies and trastuzumab-and-taxane-based therapy. Participants must have a life expectancy of at least 3 months and be able to provide a tumor sample.Check my eligibility
What is being tested?
The study tests various drug combinations (like Atezolizumab, Palbociclib) in two cohorts based on the type of breast cancer. Patients are randomly assigned to different treatments which may change if they experience disease progression or unacceptable side effects during the initial stage.See study design
What are the potential side effects?
Potential side effects include allergic reactions to drugs or their components, organ inflammation, infection risks due to immune system suppression by some treatments, blood sugar level changes possibly requiring diabetes management, and general symptoms like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman and have gone through menopause.
Select...
My cancer worsened after hormone therapy including a CDK4/6 inhibitor.
Select...
I am advised to undergo hormone therapy for my condition, not chemotherapy.
Select...
My breast cancer has worsened after the last treatment.
Select...
My breast cancer is advanced and cannot be removed with surgery.
Select...
My tumor is estrogen receptor-positive.
Select...
I am fully active or can carry out light work.
Select...
My breast cancer is ER-positive and HER2-positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until disease progression (up to 6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until disease progression (up to 6 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Concentration of Everolimus at Specified Timepoints
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)
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)
+10 moreSecondary outcome measures
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
Duration of Response, as Determined by the Investigator According to RECIST v1.1
+2 moreTrial Design
12Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2: Giredestrant + PH FDC SC + PalbociclibExperimental Treatment3 Interventions
Group II: Cohort 2: Giredestrant + PH FDC SC + AbemaciclibExperimental Treatment3 Interventions
Group III: Cohort 1: Giredestrant + SamuraciclibExperimental Treatment2 Interventions
Group IV: Cohort 1: Giredestrant + RibociclibExperimental Treatment2 Interventions
Group V: Cohort 1: Giredestrant + IpatasertibExperimental Treatment2 Interventions
Group VI: Cohort 1: Giredestrant + InavolisibExperimental Treatment2 Interventions
Group VII: Cohort 1: Giredestrant + EverolimusExperimental Treatment2 Interventions
Group VIII: Cohort 1: Giredestrant + AtezolizumabExperimental Treatment2 Interventions
Group IX: Cohort 1: Giredestrant + Abemaciclib + AtezolizumabExperimental Treatment3 Interventions
Group X: Cohort 1: Giredestrant + AbemaciclibExperimental Treatment2 Interventions
Group XI: Cohort 2: Giredestrant + PH FDC SCActive Control2 Interventions
Group XII: Cohort 1: Giredestrant MonotherapyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Atezolizumab
2017
Completed Phase 3
~5860
Giredestrant
2019
Completed Phase 2
~300
Abemaciclib
2019
Completed Phase 2
~1710
Ipatasertib
2011
Completed Phase 3
~2320
Inavolisib
2021
Completed Phase 2
~260
Ribociclib
2018
Completed Phase 3
~2330
Everolimus
2010
Completed Phase 4
~1510
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,713 Total Patients Enrolled
160 Trials studying Breast Cancer
91,442 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,430 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had major surgery on my stomach or small bowel, or I have a chronic condition causing frequent severe diarrhea.I have not received a live-virus vaccine in the last 28 days.I haven't had major heart issues or strokes in the last 3 months.I currently have a bleeding disorder.You have had or currently have a heart test (ECG) that is considered important by the doctor.I have symptoms of lung disease, such as trouble breathing.I have diabetes and need insulin.My blood and organs are functioning well.I have a digestive issue that affects how my body absorbs medication.My cancer worsened after hormone therapy including a CDK4/6 inhibitor.My blood thinner medication dose has been stable.I have not had a severe infection in the last 4 weeks.I have high calcium levels in my blood that are causing symptoms.I have not taken any strong antibiotics in the last 2 weeks.I have a history of cancer.I am a woman and have gone through menopause.I have had eye inflammation or infections, or a history of uveitis.I haven't had breast cancer treatment in the last 2 weeks or within 5 half-lives of the drug.I have not taken drugs targeting the PI3K/Akt/mTOR pathway.I have a lung condition that makes it hard to breathe without help.I don't have any eye conditions needing treatment that could affect my vision during the study.I have taken steroids within the last 2 weeks or am currently taking them.I have had hemolytic anemia or bone marrow failure.I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after treatment.I have had hormone therapy for advanced cancer, but not any SERDs in the last 28 days.I have or had an autoimmune disease or immune deficiency.I am advised to undergo hormone therapy for my condition, not chemotherapy.My breast cancer has worsened after the last treatment.I have brain metastases that are untreated or getting worse.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I have heart problems or have had them in the past.I haven't taken any immune-weakening drugs in the last 2 weeks and don't plan to during the study.My breast cancer is advanced and cannot be removed with surgery.You have a disease that can be measured and followed using specific guidelines.I have had a condition where my lymphocytes multiply unusually.I cannot confirm my eligibility for the trial due to lack of valid PIK3CA mutation test results.Your heart's pumping function is at least 50% as measured by heart scans.You are allergic to Chinese hamster ovary cell products or artificial human antibodies.I haven't taken high-dose steroids in the last 2 weeks.I haven't had cancer in the last 5 years, except for skin cancer.Your blood sugar level is too high when you haven't eaten, or your HbA1c level shows long-term high blood sugar.I haven't had major surgery in the last 4 weeks and don't expect any during the study.I have had a previous transplant of stem cells or an organ.I have not had cancer, other than breast cancer, in the last 2 years.You have had a severe allergic reaction to certain types of medications in the past.I have a condition or had surgery that affects how my body absorbs food.I have had leptomeningeal disease.I have high cholesterol or triglycerides that aren't managed.I have active tuberculosis.I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.I have been treated with an Akt inhibitor before.I have pain from my cancer that isn't relieved by treatment.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I frequently need procedures to remove excess fluid from my chest or abdomen.My tumor is estrogen receptor-positive.You have tested positive for HIV.I have an active Hepatitis B or C infection.I am fully active or can carry out light work.I haven't taken strong CYP3A4 affecting drugs recently.I have previously been treated with specific immune therapies.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My side effects from cancer treatment are mild, except for hair loss or mild nerve pain.I cannot swallow pills or have a condition that affects how my body absorbs medication.I am willing to provide a sample of my tumor for testing, if it's available.I can provide a sample of my tumor for testing.I have previously been treated with fulvestrant.You are expected to live for at least 3 more months.My breast cancer is ER-positive and HER2-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: Giredestrant + PH FDC SC + Palbociclib
- Group 2: Cohort 1: Giredestrant + Abemaciclib + Atezolizumab
- Group 3: Cohort 2: Giredestrant + PH FDC SC
- Group 4: Cohort 1: Giredestrant + Inavolisib
- Group 5: Cohort 2: Giredestrant + PH FDC SC + Abemaciclib
- Group 6: Cohort 1: Giredestrant Monotherapy
- Group 7: Cohort 1: Giredestrant + Abemaciclib
- Group 8: Cohort 1: Giredestrant + Ipatasertib
- Group 9: Cohort 1: Giredestrant + Ribociclib
- Group 10: Cohort 1: Giredestrant + Everolimus
- Group 11: Cohort 1: Giredestrant + Samuraciclib
- Group 12: Cohort 1: Giredestrant + Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger