Recruiting

CAPItello-292Capivasertib, CDK4/6 Inhibitors, and Fulvestrant for Advanced HR+/HER2- Breast Cancer

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What is being tested

Capivasertib

+ Fulvestrant

+ Palbociclib

Drug
Who is being recruted

From 18 to 99 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information CenterMore contacts
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 10, 2021

Actual date on which the first participant was enrolled.

This study, CAPItello-292, is looking at the effectiveness and safety of a combination treatment for locally advanced or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative breast cancer. The treatment includes capivasertib, CDK4/6 inhibitors, and fulvestrant. The goal is to see if adding capivasertib to the standard treatment of CDK4/6 inhibitors and fulvestrant can provide additional benefits. This research is important for people with this type of breast cancer who haven't received prior endocrine therapy in the advanced setting, as it could potentially improve their treatment options. The study has two parts. The first part, Phase Ib, will find the best dose of the combination treatment. It will look at the number of participants who experience dose-limiting toxicity, treatment-related side effects, and serious side effects. The second part, Phase III, will compare the effectiveness and safety of the combination treatment to the standard treatment. The main measure of effectiveness will be Progression Free Survival (PFS), which is the time from the start of treatment until the disease gets worse or the participant passes away. The study will also collect data on other measures such as overall response rate, duration of response, and clinical benefit rate.

Official TitleA Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
NCT04862663
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information CenterMore contacts
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

895 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.
Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.
Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.
Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
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13 exclusion criteria prevent from participating
Any of these clinically significant abnormalities of glucose metabolism at screening: . diabetes mellitus type I or type II requiring insulin treatment . Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol)
Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician.
Any prior treatment with, AKT, PI3K or mTOR inhibitors.
Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)

Group II

Experimental
Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b)

Group III

Active Comparator
Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)

Group IV

Experimental
Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b)

Group 5

Experimental
Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 283 locations

Recruiting

Research Site

Tucson, United StatesOpen Research Site in Google Maps
Recruiting

Research Site

Fountain Valley, United States
Recruiting

Research Site

Glendale, United States
Recruiting

Research Site

Los Angeles, United States
Recruiting
283 Study Centers