Breast CancerNCT07214610
Carolina Breast Cancer Study Phase 4
An observational study of Breast Cancer and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The Carolina Breast Cancer Study, Phase 4 (CBCS4) is a prospective, single-arm observational study examining interactions between tumor biology, health access, and patient behavior study. CBCS4 builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- How many people
- 3,300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 31 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study Population will be 3300 participants with first-time invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged <50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 <50, 875 ≥50) will be included.
Who may be able to join
- women with invasive breast cancer
- live in 59 counties in North Carolina
Who cannot join
- women with ductal carcinoma in situ (DCIS)
- live outside of 59 counties of North Carolina
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Population-Based Molecular Epidemiology of Breast Cancer, Carolina Breast Cancer Study, Phase 4
The Carolina Breast Cancer Study, Phase 4 (CBCS4) is a prospective, single-arm observational study examining interactions between tumor biology, health access, and patient behavior study.
CBCS4 builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, and patient engagement must also be evaluated.
Read more
Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, and initial treatment. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks.
Medical record abstraction will be performed to confirm diagnoses through pathology reports and to collect clinical data, including TNM stage, ER/PR/HER2 status, and treatment history. Diagnostic tissue blocks will be requested from referring pathologists. Blood or saliva samples will be collected for DNA extraction, storage, and genotyping of breast cancer susceptibility genes. Tumor tissue blocks will be used for tissue microarray (TMA) construction, with up to nine cores obtained from each specimen. Central pathology review will be conducted to confirm diagnoses through evaluation of H\&E slides. TMAs will be analyzed by immunohistochemistry (IHC) to classify tumors into molecular subtypes, and a subset of samples will undergo RNA-based qtrs.-PCR for molecular subtype validation.
Participants will be recontacted every 9 to 12 months for up to 10 years to update medical history, treatment information, and patient-reported outcomes.
Longitudinal follow-up data will be used to assess treatment disparities, particularly among patients with aggressive tumor subtypes, evaluate quality of life and barriers to care using validated assessment tools, and support survivorship through the provision of educational updates and care navigation resources
Read the detailed description
Study Population will be 3300 participants with invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged <50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 <50, 875 ≥50) will be included
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- subtypes of breast cancer, genetic factors, disparities, tumor biology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed with invasive breast cancer | Participants with newly diagnosed, first-time invasive breast cancer who live in 59 North Carolina counties. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Recurrence
Tumor recurrence will be identified via electronic medical records based on clinical documentation of local, regional, or distant recurrence of the primary cancer. The date and location of recurrence will be recorded using standardized clinical criteria.
Measured: from baseline up to 10 years
Incidence of Second Primary Tumors
Second primary tumors will be identified through electronic medical records and pathology reports. Criteria for classification as a second primary cancer and date of diagnosis will follow standard oncology definitions, distinct from recurrence of the original tumor
Measured: from Baseline up to 10 years
Breast Cancer-Specific and All-Cause Mortality
Mortality data, including breast cancer-specific and all-cause mortality, will be collected from electronic medical records and/or linked national death registries. Information will include vital status, cause of death, and date of death.
Measured: from Baseline up to 10 years
Quality of life assessed using Functional Assessment of Cancer Therapy - Breast (FACT-B)
Quality of life will be assessed using Functional Assessment of Cancer Therapy - Breast (FACT-B) which is a validated, patient-reported outcome measure designed to assess quality of life in individuals with breast cancer. It combines the general FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire with a breast cancer-specific subscale. The tool evaluates five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to breast cancer. The FACT-B consists of 37 items, combining the 27-item FACT-G (general quality of life) and a 10-item Breast Cancer Subscale (BCS). Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Higher scores indicate better quality of life.
Measured: from Baseline up to 10 years
Long-term survivorship experiences
Long-term survivorship experiences will be assessed using a matrix of questionnaires and surveys, including but not limited to tracking social determinants of health, behaviors that increase risk of breast cancer (e.g., physical and sedentary behavior, weight loss/gain, alcohol/tobacco use), access to medical care and breast cancer screening, barriers to care (including finances, transportation security, food insecurity, etc.), financial toxicity (cf. FACIT-COST, a validated 12-item questionnaire with a 5-point Likert-type scale that is used to measure financial distress and hardship in cancer patients), and unmet needs (cf. Cancer Survivors Unmet Needs, a validated 42-item questionnaire covering unmet needs, positive changes, and a free response option in which a person reports unmet needs and weighs their severity).
Measured: from Baseline up to 10 years
Sequelae related to treatment and psychosocial factors
Sequelae will be assisted using a matrix of questionnaires and surveys, including but not limited to resilience (cf. Connor-Davidson Resilience Scale-10, a validated 10-item questionnaire with a 5-point Likert-type scale that measures the ability to cope with stress, trauma, and adversity), fear of recurrence (cf. Fear of Cancer Recurrence Scale, a validated 7-item questionnaire with a 5-point Likert-type scales and an 11-point scale producing a measure of the impact of fear of recurrence on a person), and self-identity (cf. Superwoman Schema, a validated 35-item questionnaire aimed for women to report how much statements of common sociocultural expectations and behaviors apply and affect each them).
Measured: from Baseline up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start28 Nov 2023
- Primary completion31 Dec 2044 (estimated)
- Study completion31 Dec 2044 (estimated)
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.
- 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
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Melissa A Troester, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214610
- Sponsor's protocol ID
- 21-0956
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Molecular Epidemiology of Breast Cancer, Carolina Breast Cancer Study, Phase 4
- ClinicalTrials.gov ID
- NCT07214610
- Acronym / sponsor ID
- 21-0956
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- subtypes of breast cancer, genetic factors, disparities, tumor biology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Dec 2044 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 9 Oct 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.
The Carolina Breast Cancer Study, Phase 4 (CBCS4) is a prospective, single-arm observational study examining interactions between tumor biology, health access, and patient behavior study.
CBCS4 builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, and patient engagement must also be evaluated.
Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, and initial treatment. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks.
Medical record abstraction will be performed to confirm diagnoses through pathology reports and to collect clinical data, including TNM stage, ER/PR/HER2 status, and treatment history. Diagnostic tissue blocks will be requested from referring pathologists. Blood or saliva samples will be collected for DNA extraction, storage, and genotyping of breast cancer susceptibility genes. Tumor tissue blocks will be used for tissue microarray (TMA) construction, with up to nine cores obtained from each specimen. Central pathology review will be conducted to confirm diagnoses through evaluation of H\&E slides. TMAs will be analyzed by immunohistochemistry (IHC) to classify tumors into molecular subtypes, and a subset of samples will undergo RNA-based qtrs.-PCR for molecular subtype validation.
Participants will be recontacted every 9 to 12 months for up to 10 years to update medical history, treatment information, and patient-reported outcomes.
Longitudinal follow-up data will be used to assess treatment disparities, particularly among patients with aggressive tumor subtypes, evaluate quality of life and barriers to care using validated assessment tools, and support survivorship through the provision of educational updates and care navigation resources
Detailed description
Study Population will be 3300 participants with invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged <50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 <50, 875 ≥50) will be included
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed with invasive breast cancer | – | –Participants with newly diagnosed, first-time invasive breast cancer who live in 59 North Carolina counties. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population will be 3300 participants with first-time invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged <50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 <50, 875 ≥50) will be included.
Key inclusion criteria (2 listed)
- women with invasive breast cancer
- live in 59 counties in North Carolina
Key exclusion criteria (2 listed)
- women with ductal carcinoma in situ (DCIS)
- live outside of 59 counties of North Carolina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor Recurrence
Time frame: from baseline up to 10 years
Tumor recurrence will be identified via electronic medical records based on clinical documentation of local, regional, or distant recurrence of the primary cancer. The date and location of recurrence will be recorded using standardized clinical criteria.
Incidence of Second Primary Tumors
Time frame: from Baseline up to 10 years
Second primary tumors will be identified through electronic medical records and pathology reports. Criteria for classification as a second primary cancer and date of diagnosis will follow standard oncology definitions, distinct from recurrence of the original tumor
Breast Cancer-Specific and All-Cause Mortality
Time frame: from Baseline up to 10 years
Mortality data, including breast cancer-specific and all-cause mortality, will be collected from electronic medical records and/or linked national death registries. Information will include vital status, cause of death, and date of death.
Quality of life assessed using Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: from Baseline up to 10 years
Quality of life will be assessed using Functional Assessment of Cancer Therapy - Breast (FACT-B) which is a validated, patient-reported outcome measure designed to assess quality of life in individuals with breast cancer. It combines the general FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire with a breast cancer-specific subscale. The tool evaluates five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to breast cancer. The FACT-B consists of 37 items, combining the 27-item FACT-G (general quality of life) and a 10-item Breast Cancer Subscale (BCS). Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Higher scores indicate better quality of life.
Long-term survivorship experiences
Time frame: from Baseline up to 10 years
Long-term survivorship experiences will be assessed using a matrix of questionnaires and surveys, including but not limited to tracking social determinants of health, behaviors that increase risk of breast cancer (e.g., physical and sedentary behavior, weight loss/gain, alcohol/tobacco use), access to medical care and breast cancer screening, barriers to care (including finances, transportation security, food insecurity, etc.), financial toxicity (cf. FACIT-COST, a validated 12-item questionnaire with a 5-point Likert-type scale that is used to measure financial distress and hardship in cancer patients), and unmet needs (cf. Cancer Survivors Unmet Needs, a validated 42-item questionnaire covering unmet needs, positive changes, and a free response option in which a person reports unmet needs and weighs their severity).
Sequelae related to treatment and psychosocial factors
Time frame: from Baseline up to 10 years
Sequelae will be assisted using a matrix of questionnaires and surveys, including but not limited to resilience (cf. Connor-Davidson Resilience Scale-10, a validated 10-item questionnaire with a 5-point Likert-type scale that measures the ability to cope with stress, trauma, and adversity), fear of recurrence (cf. Fear of Cancer Recurrence Scale, a validated 7-item questionnaire with a 5-point Likert-type scales and an 11-point scale producing a measure of the impact of fear of recurrence on a person), and self-identity (cf. Superwoman Schema, a validated 35-item questionnaire aimed for women to report how much statements of common sociocultural expectations and behaviors apply and affect each them).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink 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.
Melissa A Troester, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
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 and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 30 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Tumor Recurrence (time frame: from baseline up to 10 years). The study lists 6 primary outcomes in all. 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 30 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.