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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 64 months.
Awards & highlights

CAPItello-292 Trial 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.Check my eligibility
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.See study design
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.

CAPItello-292 Trial 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.

CAPItello-292 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 64 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 64 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Phase III: 1. Overall Survival (OS).
Phase III: 10. Plasma concentration of capivasertib pre- and post-dose.
Phase III: 11. The number of participants with adverse events.
+20 more

CAPItello-292 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
~3690
Palbociclib
2017
Completed Phase 3
~3760
Ribociclib
2018
Completed Phase 3
~2330
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,387 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862663 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to people who are not yet 80 years old?

"The age limit for participants in this trial is 18 years old up to 99 years young."

Answered by AI

What is the FDA's most recent decision on Capivasertib?

"Capivasertib's safety is estimated to be a 3. This rating comes from the fact that it is a Phase 3 trial, indicating that there are both efficacy and safety data supporting its use."

Answered by AI

What are the main indications for Capivasertib?

"Capivasertib is most frequently used in the treatment of malignant neoplasms. However, this medication can also be effective against pik3ca gene mutation, progression, disease, and prior endocrine therapy."

Answered by AI

In how many different medical clinics is this trial being run?

"This study is still looking for patients at 6 research sites. 3 of these facilities are in Aurora, San Francisco and Nashville with the remaining three located elsewhere. If you want to participate in this trial, please choose the location that is most convenient for you to help reduce travel-related stressors."

Answered by AI

Who meets the screening criteria for this particular clinical trial?

"Eligibility requirements for this study include a breast cancer diagnosis and being between the ages of 18-99. The trial is hoping to enroll approximately 700 individuals."

Answered by AI

What are the goals of this particular clinical trial?

"The primary outcome of this study will be assessed over a 24-month period and is defined as Progression Free Survival (PFS). Secondary outcomes include Partial area under the plasma concentration-time curve from zero to 24 hours post-dose (AUC0-24h), Minimum observed plasma drug concentration (Cmin), and Progression Free Survival 2 (PFS2) - time from randomisation to the earliest of the progression event, subsequent to first therapy or death."

Answered by AI

Are there any ongoing or previous investigations using Capivasertib?

"Capivasertib was first studied 16 years ago at Lowell General Hospital. So far, there have been a total of 165 completed studies. Currently, there are 260 live trials being conducted; many in Aurora, Colorado."

Answered by AI

Can new participants sign up for this clinical trial?

"The information available on clinicaltrials.gov verifies that this study is still looking for patients and was last updated on 10/11/2022. It was originally posted 5/10/2021 and they are hoping to enroll 700 people total at 6 different locations."

Answered by AI

How many research participants are part of this trial?

"The clinicaltrials.gov website says that this experiment is still looking for subjects. The posting date was May 10th, 2021 and the latest update was on October 11th, 2022. They want to have 700 people involved total, signing up at 6 different locations."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I would like to try a clinical trial for one to be apart of any research that may help other people. 2) I'm not entirely comfortable with my current Oncologist.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Research Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
2021. "Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04862663.
All > Breast Cancer Austin
~488 spots leftby Nov 2027
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