RECRUITING

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A 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)

Official Title

A 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)

Quick Facts

Study Start:2021-05-10
Study Completion:2029-08-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04862663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com
AstraZeneca Breast Cancer Study Locator Service
CONTACT
1-877-400-4655
az-bcsl@careboxhealth.com

Study Locations (Sites)

Research Site
Tucson, Arizona, 85719
United States
Research Site
Glendale, California, 91204
United States
Research Site
Los Angeles, California, 90033
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
San Francisco, California, 94158
United States
Research Site
Santa Barbara, California, 93105
United States
Research Site
Santa Rosa, California, 92805
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Newark, Delaware, 19713
United States
Research Site
Quincy, Illinois, 62305
United States
Research Site
Fort Wayne, Indiana, 46804
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Baton Rouge, Louisiana, 70809
United States
Research Site
Covington, Louisiana, 70433
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Baltimore, Maryland, 21202
United States
Research Site
Baltimore, Maryland, 21229
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Detroit, Michigan, 48236
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Hannibal, Missouri, 63401
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
Camden, New Jersey, 08103
United States
Research Site
Brooklyn, New York, 11220
United States
Research Site
Mineola, New York, 11501
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10065
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Gresham, Oregon, 97030
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Greenville, South Carolina, 29607
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
San Antonio, Texas, 78240
United States
Research Site
Falls Church, Virginia, 22042
United States
Research Site
Leesburg, Virginia, 20176
United States
Research Site
Midlothian, Virginia, 23114
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-10
Study Completion Date2029-08-14

Study Record Updates

Study Start Date2021-05-10
Study Completion Date2029-08-14

Terms related to this study

Keywords Provided by Researchers

  • Locally advanced (inoperable) or Metastatic Breast Cancer

Additional Relevant MeSH Terms

  • Locally Advanced (Inoperable) or Metastatic Breast Cancer