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Active, not recruitingNCT04661982Updated Dec 5, 2025

Long Term Follow-Up in Patients With Stage 0-IIIC Breast Cancer

An observational study in Breast Cancer, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by City of Hope Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
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Study 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 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:

I. 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.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 500 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with stage 0-IIIC breast cancer

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (long term follow-up)

    Patients undergo long term follow-up and complete questionnaires.

    Other: Long-term Follow-up · Other: Questionnaire Administration · Other: Quality-of-Life Assessment

Interventions

  • OtherLong-term Follow-up

    Undergo long term follow-up

    Also known as: LONG-TERM FOLLOW-UP, Long-term Follow-up

  • OtherQuestionnaire Administration

    Ancillary studies

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 years

  2. FACT- Cog

    Functional Assessment of Cancer Therapy Cognitive Function

    Time frame: Change from pre-treatment baseline over a 2-year period

  3. Cancer induced immune dysfunction

    Will analyze patients' tumor, lymph node, and blood samples

    Time frame: Up to 12 years

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Study locations

1 site
  • City of Hope Medical Center
    Duarte, California 91010, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04661982
Lead sponsor
City of Hope Medical Center
Responsible party
Sponsor
First posted
Dec 10, 2020
Start date
Jul 6, 2010
Primary completion
Nov 24, 2026 (estimated)
Completion
Nov 24, 2026 (estimated)
Last update
Dec 5, 2025

Study contacts

Joanne Mortimer, MD
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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