Interview of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant

NCT07008963 | Completed FDA Drug

• 1 other identifier: D3615R00004
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen

  The interview will be conducted using a discussion guide tailored to specific questions to be explored in this study, developed by the study team. No formal scale or validated questionnaire will be used to assess the outcomes

  Day 1

Secondary Outcomes (1)

• Self-reported tolerability experiences related to patients' ability to follow the prescribed regimen and stay on treatment among those who received capivasertib + fulvestrant.

  Day 1

Interventions

non-interventional OTHER

This is a non-interventional, observational study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients with HR+/HER2- metastatic breast cancer who received capivasertib + fulvestrant

You may qualify if:

• Adult (over the age of 18 years)
• Diagnosed with HR+/HER2- metastatic breast cancer
• Received at least 1 week of capivasertib + fulvestrant (Patients will be invited to provide documents demonstrating the use of capivasertib. Patients will be able to participate even if unable to obtain such documentation)

You may not qualify if:

• Patients who had discontinued capivasertib for more than 6 months before the date of the interview
• Unable or unwilling to follow study procedures (including providing informed consent)
• Not proficient in spoken English, as assessed by the moderator
• Receiving capivasertib in a clinical trial setting
• Patients who are not able to recall instruction for administration of capivasertib in a manner consistent with the labeling (e.g. 4 days on followed by 3 days off)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Redwood Shores, California, 94065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 6, 2025
• Study Start: July 31, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)