Breast CancerNCT05926024
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subjects. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise Recall Patient Reported Outcomes, Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes and Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 31 Jan 2028
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women have been diagnosed with breast cancer and cancer-free for equal or more than 3 years.
Who may be able to join
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥21 years at the time of consent.
- Able to read and comprehend English.
- No breast cancer recurrence or metastasis; no other cancer diagnosis other than basal cell or squamous cell cancers.
Who cannot join
- Unable to read or comprehend English.
- Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subjects.
There will be 2 groups. Cohort A: Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consent for this study activities. Cohort B: Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used.
Furthermore, the long-term effects of treatment and a biomarker of aging cyclin-dependent kinase inhibitor 2A (CDKN2A,p16INK4a) and relation will be assessed.
- Conditions
- Breast Cancer
- Being tested
- Exercise Recall Patient Reported Outcomes, Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes, Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes, Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)
- Keywords
- Quality of life, Adverse Events, Cancer free
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Recall Patient Reported OutcomesBehavioural
Questionnaire items inquire about (1) the number of days of the week participants engage in walking for pleasure or exercise and (2) the number of minutes per day that participants engage in walking for pleasure or exercise. The same two questions are repeated pertaining to exercise in general. Completion of these items takes 1 minute to complete.
Health Behavior Questionnaire (HBQ)30 Patient Reported OutcomesBehavioural
Health Behavior Questionnaire (HBQ)30 -- Questionnaire items pertain to the history of smoking, engagement in vigorous physical activity, alcohol consumption, and mortality status of parents, and take less than 1 minute to complete.
Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported OutcomesBehavioural
Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported OutcomesBehavioural
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item scale that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". This measure takes about 1 minute to complete.
Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)Behavioural
PROMIS Cognitive Function (Short Form 8a) includes 8 items on a 5-point Likert-type scale ranging from very often/several times a day = 1 to never = 5, with higher scores indicating greater perceived loss of cognitive function. This measure takes less than 1 minute to complete.
Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)Behavioural
Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days (0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet, discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small objects in hands, trouble walking, and pain in hands/feet in cold temperatures. This measure takes about t 1 minute to complete.
Patient Reported Outcomes PROMISBehavioural
PROMIS Measures Global Health (10 items), Anxiety (6 items), Depression (8 items), and Stress (10 items). All items are on a 5-point Likert-type scale form never to very often. Completion of all 34 items should take no more than 3 minutes to complete.
Patient Reported Outcomes FACT-Endocrine SymptomsBehavioural
FACT-Endocrine Symptom is a 19-item questionnaire inquiring about hot flashes, cold sweats, night sweats; vaginal discharge, itching/irritation, bleeding or spotting, dryness; pain or discomfort with intercourse, loss of interest in sex; weight gain; lightheadedness; vomiting; diarrhea; headaches; bloating; breast sensitivity/tenderness; mood swings; irritability; pain in joints. Responses are on a 5- point Likert-type scale from not at all to very much. This measure takes about two minutes to complete.
Patient Reported Outcomes Penn Arthralgia Aging SurveyBehavioural
Penn Arthralgia Aging Survey is an 8-item scale inquiring about joint pain, with a 4-point response scale from not at all to complete. Items pertaining to slowing down, stopping, being hesitant, unable to do this, and feeling unusually aged. This measure takes less than a minute to complete.
Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE)Behavioural
PRO-CTCAE (patient-reported CTCAE) is Patients will be asked about the side effects of chemotherapy treatment at baseline, every 3 weeks during chemotherapy, at the end of chemotherapy, and at 6 months post-chemotherapy. Patients are asked to rate "in the past 7 days" the average severity, frequency, and intensity and a scale from 1=none/never/not at all to 5=very severe/very much/almost all of the time. Symptom list: Abdominal pain, Constipation, Diarrhea. Mucositis oral, Nausea, Vomiting, Edema limbs, Fatigue, Pain, Arthralgia, Myalgia, Peripheral sensory neuropathy, Anxiety, Depression, Insomnia, Dyspnea, Rash maculopapular, Hot flashes. Completion of these measures takes 5 minutes for an average patient
p16 tumor suppressor geneDiagnostic test
Blood samples will be obtained to test the p16 tumor suppressor gene from the subjects It is voluntary..
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities. Receives: Diagnostic Test: p16 tumor suppressor gene | |
| Cohort B | Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used. Receives: Behavioral: Exercise Recall Patient Reported Outcomes; Behavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes; Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes; Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes; Behavioral: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a); Behavioral: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12); Behavioral: Patient Reported Outcomes PROMIS; Behavioral: Patient Reported Outcomes FACT-Endocrine Symptoms; Behavioral: Patient Reported Outcomes Penn Arthralgia Aging Survey; Behavioral: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE); Diagnostic Test: p16 tumor suppressor gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Well-being
Change in Functional Well-being will be measured by FACT-G Functional Well-bein in participants who received chemotherapy (Cohort A).
Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
Measured: At least 3 years after completion of chemotherapy
Secondary outcomes (7)
Comparison of Functional well-being- Cohort B
Comparison of Functional well-being will be measured as a comparison of FACT-G Functional Well-being scores of participants who received chemotherapy (Cohort A)and participant who did not receive chemotherapy (Cohort B).
Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
Measured: At least 3 years after completion of chemotherapy
Changes in self-reported cognition-Cohort A
Changes in self-reported cognition will be assessed using PROMIS Cognitive Function (Short Form 8a), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
PROMIS Cognitive Function (Short Form 8a) This measure includes 8 items on a 5-point Likert-type scale ranging from very often/several times a day = 1 to never = 5, with higher scores indicating greater perceived loss of cognitive function.
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported cognition- Cohort B
Changes in self-reported cognition will be assessed using PROMIS Cognitive Function (Short Form 8a), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
PROMIS Cognitive Function (Short Form 8a) This measure includes 8 items on a 5-point Likert-type scale ranging from very often/several times a day = 1 to never = 5, with higher scores indicating greater perceived loss of cognitive function.
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort A
Changes in self-reported peripheral neuropathy will be assessed using Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
FACT/GOG-NTX-12 is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days (0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet, discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small objects in hands, trouble walking, and pain in hands/feet in cold temperatures. The increasing score reflects worse neuropathy.
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort B
Changes in self-reported peripheral neuropathy will be assessed using Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
FACT/GOG-NTX-12 is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days (0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet, discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small objects in hands, trouble walking, and pain in hands/feet in cold temperatures. The increasing score reflects worse neuropathy.
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported Fatigue-Cohort A
Changes in self-reported Fatigue will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
Functional Assessment of Chronic Illness Therapy-Fatigue (TFACIT-F) is a 13-item scale that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days".
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported Fatigue-Cohort B
Changes in self-reported Fatigue will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
Functional Assessment of Chronic Illness Therapy-Fatigue (TFACIT-F) is a 13-item scale that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days".
Measured: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Jan 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926024
- Sponsor's protocol ID
- LCCC2229
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
- ClinicalTrials.gov ID
- NCT05926024
- Acronym / sponsor ID
- LCCC2229
- Conditions
- Breast Cancer
- Keywords
- Quality of life, Adverse Events, Cancer free
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 3 Jul 2023 (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.
This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subjects.
There will be 2 groups. Cohort A: Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consent for this study activities. Cohort B: Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used.
Furthermore, the long-term effects of treatment and a biomarker of aging cyclin-dependent kinase inhibitor 2A (CDKN2A,p16INK4a) and relation will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: p16 tumor suppressor geneWomen who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities. |
| Cohort B | – | Behavioral: Exercise Recall Patient Reported Outcomes, Behavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes, Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes, Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes, Behavioral: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a), Behavioral: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12), Behavioral: Patient Reported Outcomes PROMIS, Behavioral: Patient Reported Outcomes FACT-Endocrine Symptoms, Behavioral: Patient Reported Outcomes Penn Arthralgia Aging Survey, Behavioral: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE), Diagnostic Test: p16 tumor suppressor geneWomen with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women have been diagnosed with breast cancer and cancer-free for equal or more than 3 years.
Key inclusion criteria (6 listed)
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥21 years at the time of consent.
- Able to read and comprehend English.
Key exclusion criteria (2 listed)
- Unable to read or comprehend English.
- Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.
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 |
|---|---|---|
| Exercise Recall Patient Reported OutcomesQuestionnaire items inquire about (1) the number of days of the week participants engage in walking for pleasure or exercise and (2) the number of minutes per day that participants engage in walking for pleasure or exercise. The same two questions are repeated pertaining to exercise in general. Completion of these items takes 1 minute to complete. | Behavioural | Cohort B |
| Health Behavior Questionnaire (HBQ)30 Patient Reported OutcomesHealth Behavior Questionnaire (HBQ)30 -- Questionnaire items pertain to the history of smoking, engagement in vigorous physical activity, alcohol consumption, and mortality status of parents, and take less than 1 minute to complete. | Behavioural | Cohort B |
| Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported OutcomesFunctional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete. | Behavioural | Cohort B |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported OutcomesFunctional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item scale that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". This measure takes about 1 minute to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)PROMIS Cognitive Function (Short Form 8a) includes 8 items on a 5-point Likert-type scale ranging from very often/several times a day = 1 to never = 5, with higher scores indicating greater perceived loss of cognitive function. This measure takes less than 1 minute to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days (0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet, discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small objects in hands, trouble walking, and pain in hands/feet in cold temperatures. This measure takes about t 1 minute to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes PROMISPROMIS Measures Global Health (10 items), Anxiety (6 items), Depression (8 items), and Stress (10 items). All items are on a 5-point Likert-type scale form never to very often. Completion of all 34 items should take no more than 3 minutes to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes FACT-Endocrine SymptomsFACT-Endocrine Symptom is a 19-item questionnaire inquiring about hot flashes, cold sweats, night sweats; vaginal discharge, itching/irritation, bleeding or spotting, dryness; pain or discomfort with intercourse, loss of interest in sex; weight gain; lightheadedness; vomiting; diarrhea; headaches; bloating; breast sensitivity/tenderness; mood swings; irritability; pain in joints. Responses are on a 5- point Likert-type scale from not at all to very much. This measure takes about two minutes to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes Penn Arthralgia Aging SurveyPenn Arthralgia Aging Survey is an 8-item scale inquiring about joint pain, with a 4-point response scale from not at all to complete. Items pertaining to slowing down, stopping, being hesitant, unable to do this, and feeling unusually aged. This measure takes less than a minute to complete. | Behavioural | Cohort B |
| Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE)PRO-CTCAE (patient-reported CTCAE) is Patients will be asked about the side effects of chemotherapy treatment at baseline, every 3 weeks during chemotherapy, at the end of chemotherapy, and at 6 months post-chemotherapy. Patients are asked to rate "in the past 7 days" the average severity, frequency, and intensity and a scale from 1=none/never/not at all to 5=very severe/very much/almost all of the time. Symptom list: Abdominal pain, Constipation, Diarrhea. Mucositis oral, Nausea, Vomiting, Edema limbs, Fatigue, Pain, Arthralgia, Myalgia, Peripheral sensory neuropathy, Anxiety, Depression, Insomnia, Dyspnea, Rash maculopapular, Hot flashes. Completion of these measures takes 5 minutes for an average patient | Behavioural | Cohort B |
| p16 tumor suppressor geneBlood samples will be obtained to test the p16 tumor suppressor gene from the subjects It is voluntary.. | Diagnostic test | Cohort A, Cohort B |
Primary outcome
Change in Functional Well-being
Time frame: At least 3 years after completion of chemotherapy
Change in Functional Well-being will be measured by FACT-G Functional Well-bein in participants who received chemotherapy (Cohort A). Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
7 secondary outcomes
Comparison of Functional well-being- Cohort B
Time frame: At least 3 years after completion of chemotherapy
Changes in self-reported cognition-Cohort A
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported cognition- Cohort B
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort A
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort B
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported Fatigue-Cohort A
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported Fatigue-Cohort B
Time frame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
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 11 Mar 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Hyman Muss, MD 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, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 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?
Change in Functional Well-being (time frame: At least 3 years after completion of chemotherapy). 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 11 Mar 2026.