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Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life

60% of all cancers and 70% of cancer mortality occur in people greater than 65 years of age,
defining cancer as a disease of older adults. Breast cancer is no exception to this rule
where almost half of all new breast cancers in the United States are diagnosed in women 65
years of age or older1. Despite the association between cancer and aging, treatment
recommendations and data acquired from prospective clinical trials in older women with
breast cancer are sparse. As a result, physicians and older adults have limited data to
guide treatment recommendation, make dose adjustments and manage toxicities in older adults.
Aging is invariably associated with changes in physiology which can impact the
pharmacokinetics and pharmacodynamics of cancer therapy. The potential for increased toxic
effects in the older patient becomes an important concern. Therefore, it may not be
reasonable to extrapolate data regarding toxicity from clinical trials, which primarily
include younger, healthier patients. In addition, the age-related impact of adjuvant therapy
on the functional status and quality of life of older versus younger adults has not been
rigorously evaluated, and risk factors for toxicity, other than chronological age, need to
be studied among older adults receiving anthracycline and non-anthracycline based
chemotherapy regimens.

The goal of this study is to prospectively describe the longitudinal trajectory of
functional status, comorbidity, and quality of life from before the initiation of
chemotherapy to 6 months after the completion of treatment in older (65 and older) and
younger (under 65) adults. We will determine the effect of pre-treatment physical
functioning on physical recovery (ie, physical function at end of chemotherapy and 6 months
later) after the course of adjuvant chemotherapy. In addition, we will explore if factors
other than chronological age (functional status, comorbid medical conditions, nutritional
status, psychological state, cognitive function, and social support) predict which patients
are more likely to experience treatment morbidity (defined as grade 3-5 toxicity,
hospitalization or urgent care visits, dose reduction or delay, or premature discontinuation
of the planned chemotherapy course)

Inclusion Criteria:

1. Patients with stages I-III breast cancer receiving adjuvant chemotherapy

2. Able to understand English

3. Able to provide informed consent

4. Patients of any age and performance status are eligible

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Arti Hurria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

November 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Adjuvant Chemotherapy
  • Breast Neoplasms



City of Hope Duarte, California  91010