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NCT Number: NCT04661982

Long Term Follow-Up in Patients With Stage 0-IIIC 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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or radiation * (Note: Subjects who develop locoregional or systemic recurrence while enrolled on this protocol will be withdrawn, and will continue their care with their primary oncology providers only)

Treatment and study plan

Long-term Follow-Up

Other

Undergo long term follow-up

Other names: LONG-TERM FOLLOW-UP, Long-term Follow-up

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. 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.

  2. FACT- Cog

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

    Functional Assessment of Cancer Therapy Cognitive Function

  3. Cancer induced immune dysfunction

    Time frame: Up to 12 years

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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

Long Term Follow Up After Breast Cancer

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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