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Protein Kinase Inhibitor

Capivasertib + CDK4/6 Inhibitors + Fulvestrant for Breast Cancer (CAPItello-292 Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required.
Are you currently able to carry out your normal daily activities without significant restrictions?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 69 months.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new cancer drug combo vs. the standard of care to see if the new combo is more effective.

Who is the study for?
This trial is for adults with advanced or metastatic HR+/HER2- breast cancer who have previously tolerated certain drugs (palbociclib, ribociclib, abemaciclib) and are eligible for fulvestrant therapy. They must have had a recurrence or progression of cancer after hormone treatment. Exclusions include brain metastases not stable off steroids, significant prior toxicities from treatments, recent radiotherapy, previous AKT/PI3K/mTOR inhibitors use in the metastatic setting, other primary malignancy within 2 years except if low risk of recurrence.
What is being tested?
The study tests Capivasertib combined with CDK4/6 inhibitors (Palbociclib/Ribociclib/Abemaciclib) and Fulvestrant against just CDK4/6 inhibitors and Fulvestrant in patients with specific breast cancer types. It's an open-label trial where participants know what treatment they're getting; it randomly assigns them to either the test group or control group.
What are the potential side effects?
Potential side effects may include issues related to blood sugar levels like diabetes requiring insulin treatment; heart-related problems such as abnormal ECG readings or uncontrolled blood pressure; and complications from past surgeries or injuries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for fulvestrant and at least one CDK4/6 inhibitor like palbociclib, ribociclib, or abemaciclib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 69 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 69 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase III: 1. Progression Free Survival (PFS).
Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.
Phase Ib: 2. The number of participants with treatment-related adverse events.
+1 more
Secondary study objectives
Phase III: 1. Overall Survival (OS).
Phase III: 10. The number of participants with adverse events.
Phase III: 11. The number of participants with serious adverse events.
+19 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Capivasertib Plus Ribociclib and FulvestrantExperimental Treatment1 Intervention
Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b)
Group II: Capivasertib Plus Palbociclib and FulvestrantExperimental Treatment3 Interventions
Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b)
Group III: Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)Experimental Treatment1 Intervention
Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)
Group IV: Capivasertib Plus Abemaciclib and FulvestrantExperimental Treatment1 Intervention
Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b)
Group V: Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)Active Control1 Intervention
Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130
Fulvestrant
2011
Completed Phase 3
~3790
Palbociclib
2017
Completed Phase 3
~3790
Ribociclib
2018
Completed Phase 3
~2420
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,421 Previous Clinical Trials
289,121,908 Total Patients Enrolled
178 Trials studying Breast Cancer
1,245,208 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862663 — Phase 3
~395 spots leftby Nov 2027
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