Metastatic Breast CancerNCT07008963
Interview of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 1 site in United States.
Trial summary
A cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- non-interventional
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to 28 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults patients with HR+/HER2- metastatic breast cancer who received capivasertib + fulvestrant
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional, Observational Qualitative Interview Study of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant
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
- Being tested
- non-interventional
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
This is a non-interventional, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start31 Jul 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008963
- Sponsor's protocol ID
- D3615R00004
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Observational Qualitative Interview Study of Patients With HR+/HER2- Metastatic Breast Cancer Who Received Capivasertib + Fulvestrant
- ClinicalTrials.gov ID
- NCT07008963
- Acronym / sponsor ID
- D3615R00004
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults patients with HR+/HER2- metastatic breast cancer who received capivasertib + fulvestrant
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionalThis is a non-interventional, observational study | Other | – |
Primary outcome
Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen
Time frame: Day 1
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
1 secondary outcome
Self-reported tolerability experiences related to patients' ability to follow the prescribed regimen and stay on treatment among those who received capivasertib + fulvestrant.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient attitude and experience reported by patients regarding capivasertib dosing schedule and regimen (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.