Breast CancerNCT04661982
Long Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Long-term Follow-up, Questionnaire Administration and Quality-of-Life Assessment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2010to 24 Nov 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stage 0-IIIC breast cancer
Who may be able to join
- Diagnosis of breast cancer, stage 0-IIIC
- Partial or entire treatment at City of Hope
- Must be registered before adjuvant therapy and ideally before definitive local therapy
Who cannot join
- Stage IV breast cancer
- Recurrent breast cancer
- Prior cancers, chemotherapy or radiation * (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Long Term Follow Up After Breast Cancer
This trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.
Read the detailed description
PRIMARY OBJECTIVES:
- To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.
II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.
III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.
OUTLINE:
Patients undergo long term follow-up and complete questionnaires.
- Conditions
- Breast Cancer
- Being tested
- Long-term Follow-up, Questionnaire Administration, Quality-of-Life Assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term Follow-upOther
Also called LONG-TERM FOLLOW-UP, Long-term Follow-up
Undergo long term follow-up
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (long term follow-up) | Patients undergo long term follow-up and complete questionnaires. Receives: Other: Long-term Follow-up; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of the study end-points
Will estimation of incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time varying characteristics such as age and body mass index (BMI). Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. Time of entry onto the study in the analysis will be from the date of diagnosis of primary disease. Stepwise logistic regression analysis of endpoints of interest at certain follow-up time may be conducted, accounting for the joint effect of such factors as age, time since diagnosis and treatment, radiation dose, chemotherapy and tumor subtype.
Measured: Up to 12 years
FACT- Cog
Functional Assessment of Cancer Therapy Cognitive Function
Measured: Change from pre-treatment baseline over a 2-year period
Cancer induced immune dysfunction
Will analyze patients' tumor, lymph node, and blood samples
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start6 Jul 2010
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Nov 2026 (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 City of Hope Medical 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Mortimer, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661982
- Sponsor's protocol ID
- 07100
- Other IDs
- NCI-2019-03481, 07100
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2012
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow Up After Breast Cancer
- ClinicalTrials.gov ID
- NCT04661982
- Acronym / sponsor ID
- 07100
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 6 Jul 2010 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 10 Dec 2020 (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 trial studies long term follow-up care in patients with stage 0-IIIC breast cancer. Collecting feedback from breast cancer patients may help researchers to define comprehensive long term follow-up care for breast cancer survivors, better understand health-related quality of life and long-term complications in breast cancer survivors, and to increase the knowledge of the mechanisms by which a patient's own immune system attempts to combat breast cancer, and what factors may make this response more successful.
Detailed description
PRIMARY OBJECTIVES:
- To provide comprehensive care to breast cancer survivors diagnosed with stage 0 to IIIC, who received at least part of their treatment at City of Hope.
II. To use the information obtained from follow-up of breast cancer survivors to describe the magnitude of risk and associated risk factors.
III. To use the information gained from follow-up of breast cancer survivors to describe health-related quality of life (HRQL) concerns in breast cancer survivors and identify those at highest risk.
OUTLINE:
Patients undergo long term follow-up and complete questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (long term follow-up) | – | Other: Long-term Follow-up, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentPatients undergo long term follow-up and complete questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage 0-IIIC breast cancer
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer, stage 0-IIIC
- Partial or entire treatment at City of Hope
- Must be registered before adjuvant therapy and ideally before definitive local therapy
Key exclusion criteria (3 listed)
- Stage IV breast cancer
- Recurrent breast cancer
- Prior cancers, chemotherapy or radiation * (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)
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 |
|---|---|---|
| Long-term Follow-upAlso: LONG-TERM FOLLOW-UP, Long-term Follow-upUndergo long term follow-up | Other | Observational (long term follow-up) |
| Questionnaire AdministrationAncillary studies | Other | Observational (long term follow-up) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (long term follow-up) |
Primary outcome
Incidence rates of the study end-points
Time frame: Up to 12 years
Will estimation of incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time varying characteristics such as age and body mass index (BMI). Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. Time of entry onto the study in the analysis will be from the date of diagnosis of primary disease. Stepwise logistic regression analysis of endpoints of interest at certain follow-up time may be conducted, accounting for the joint effect of such factors as age, time since diagnosis and treatment, radiation dose, chemotherapy and tumor subtype.
FACT- Cog
Time frame: Change from pre-treatment baseline over a 2-year period
Functional Assessment of Cancer Therapy Cognitive Function
Cancer induced immune dysfunction
Time frame: Up to 12 years
Will analyze patients' tumor, lymph node, and blood samples
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 5 Dec 2025.
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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.
Joanne Mortimer, MD principal investigator
City of Hope Medical 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 City of Hope Medical 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 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 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?
Incidence rates of the study end-points (time frame: Up to 12 years). The study lists 3 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 5 Dec 2025.