Breast CancerNCT06683482
A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
An observational study of Breast Cancer, run by Gilead Sciences at 1 site in Spain.
Trial summary
The main goal of this ethnographic study is to learn a holistic and enriched view of the behaviors, actions, and views of a group of people with advanced breast cancer (ABC) cancer living in Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2025to 28 Jul 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population includes individuals with BC subtypes in the advanced setting (TNBC, HR+/HER2-, and HER2+ [with any HR]), and also their caregivers will be observed in this study.
Who may be able to join
- Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).
- Women or men (individual and/or caregiver) over 18 years of age.
- Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).
- Individuals must have initiated at least the firstline treatment.
- Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).
- Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).
Who cannot join
- Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).
- Individual unable or unwilling to provide informed consent.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethnographic Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
The main goal of this ethnographic study is to learn a holistic and enriched view of the behaviors, actions, and views of a group of people with advanced breast cancer (ABC) cancer living in Spain. The primary objective of this study is to collect data on the psychosocial needs of (ABC) patients to identify spaces and strategies to improve these needs.
- Conditions
- Breast Cancer
- Being tested
- No intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No study drug will be administered as a part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Advanced Breast Cancer Living in Spain and their Caregivers | Participants with different types of breast cancers living in Spain will be observed in this study. Participants will not receive any study drug in this study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Responses to the Open-ended questionnaires
This qualitative ethnographic study will be carried out through the transcriptions of open-ended interviews. The variables of interest will consist of a set of sociodemographic data, as well as results from emotional and psychological.
Measured: Up to 4 weeks
Secondary outcomes (5)
Number of Participants with Responses to the Open-ended Questionnaires Related to Intimacy and Sexuality
Measured: Up to 4 weeks
Number of Participants With Responses to the Economic Impact of the Disease
Measured: Up to 4 weeks
Number of Participants With Responses Open-ended Interviews to Assess Importance of Hereditary BC, Genetic Testing and Generic Counselling in ABC Patients
Measured: Up to 4 weeks
Number of Participants With Responses to the Open-ended interviews to assess the Level of Insight and Opportunities for Access to Clinical Studies to Promote Research and Access to Novel Therapeutic Options
Measured: Up to 4 weeks
Number of Participants With Responses to the Open-ended Interviews to Assess Whether There is any Difference Between the Analyses of the Above Characteristics by BC Subtype
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start21 Feb 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683482
- Sponsor's protocol ID
- GS-ES-984-6674
- Status last verified
- Aug 2025
- First submitted
- 8 Nov 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnographic Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
- ClinicalTrials.gov ID
- NCT06683482
- Acronym / sponsor ID
- GS-ES-984-6674
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 12 Nov 2024 (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.
The main goal of this ethnographic study is to learn a holistic and enriched view of the behaviors, actions, and views of a group of people with advanced breast cancer (ABC) cancer living in Spain. The primary objective of this study is to collect data on the psychosocial needs of (ABC) patients to identify spaces and strategies to improve these needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Advanced Breast Cancer Living in Spain and their Caregivers | – | Other: No interventionParticipants with different types of breast cancers living in Spain will be observed in this study. Participants will not receive any study drug in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes individuals with BC subtypes in the advanced setting (TNBC, HR+/HER2-, and HER2+ [with any HR]), and also their caregivers will be observed in this study.
Key inclusion criteria (6 listed)
- Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).
- Women or men (individual and/or caregiver) over 18 years of age.
- Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).
- Individuals must have initiated at least the firstline treatment.
- Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).
Key exclusion criteria (3 listed)
- Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).
- Individual unable or unwilling to provide informed consent.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
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 |
|---|---|---|
| No interventionNo study drug will be administered as a part of this study. | Other | Participants with Advanced Breast Cancer Living in Spain and their Caregivers |
Primary outcome
Number of Participants With Responses to the Open-ended questionnaires
Time frame: Up to 4 weeks
This qualitative ethnographic study will be carried out through the transcriptions of open-ended interviews. The variables of interest will consist of a set of sociodemographic data, as well as results from emotional and psychological.
5 secondary outcomes
Number of Participants with Responses to the Open-ended Questionnaires Related to Intimacy and Sexuality
Time frame: Up to 4 weeks
Number of Participants With Responses to the Economic Impact of the Disease
Time frame: Up to 4 weeks
Number of Participants With Responses Open-ended Interviews to Assess Importance of Hereditary BC, Genetic Testing and Generic Counselling in ABC Patients
Time frame: Up to 4 weeks
Number of Participants With Responses to the Open-ended interviews to assess the Level of Insight and Opportunities for Access to Clinical Studies to Promote Research and Access to Novel Therapeutic Options
Time frame: Up to 4 weeks
Number of Participants With Responses to the Open-ended Interviews to Assess Whether There is any Difference Between the Analyses of the Above Characteristics by BC Subtype
Time frame: Up to 4 weeks
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 6 Aug 2025.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gilead Study Director study director
Gilead Sciences
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 Breast Cancer, run by Gilead Sciences at 1 site in Spain.
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 6 inclusion and 3 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 6 Aug 2025. 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 Spain. 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?
Number of Participants With Responses to the Open-ended questionnaires (time frame: Up to 4 weeks). 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 6 Aug 2025.