Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00681928
First received: May 20, 2008
Last updated: November 30, 2011
Last verified: November 2011

May 20, 2008
November 30, 2011
October 2007
January 2011   (final data collection date for primary outcome measure)
Impact of treatment with an aromatase inhibitor on cognitive function [ Time Frame: Prior to starting aromatase treatment and 6 months after starting the medication. ] [ Designated as safety issue: No ]
Impact of treatment with an aromatase inhibitor on cognitive function [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00681928 on ClinicalTrials.gov Archive Site
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Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy
The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer

RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment.

PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers.

OBJECTIVES:

  • Explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage I-III breast cancer vs in cancer-free, age-matched healthy volunteers.

OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity.

Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Breast cancer patients and healthy control subjects

Breast Cancer
  • Drug: anastrozole
    As determined by the subject's physician
  • Drug: letrozole
    As determined by the subject's physician
  • Other: questionnaire administration
    For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
  • Procedure: cognitive assessment
    For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
  • Procedure: psychosocial assessment and care
    For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
  • Breast Cancer patients receiving aromatase treatment
    Interventions:
    • Drug: anastrozole
    • Drug: letrozole
    • Other: questionnaire administration
    • Procedure: cognitive assessment
    • Procedure: psychosocial assessment and care
  • Healthy female controls age 60 and older
    Interventions:
    • Other: questionnaire administration
    • Procedure: cognitive assessment
    • Procedure: psychosocial assessment and care
Hurria A, Patel SK, Mortimer J, Luu T, Somlo G, Katheria V, Ramani R, Hansen K, Feng T, Chuang C, Geist CL, Silverman DH. The effect of aromatase inhibition on the cognitive function of older patients with breast cancer. Clin Breast Cancer. 2014 Apr;14(2):132-40. doi: 10.1016/j.clbc.2013.10.010. Epub 2013 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2011
January 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Patient diagnosed with breast cancer

      • Stage I-III disease
      • Estrogen receptor- and/or progesterone receptor-positive
      • Planning to start treatment with anastrozole or letrozole
    • Age-matched healthy volunteer (control)

      • No history of breast cancer
      • Not receiving adjuvant aromatase inhibitor therapy

PATIENT CHARACTERISTICS:

  • Postmenopausal
  • Able to converse, write, and read English
  • No claustrophobia (patients participating in the PET scan correlative study)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormonal therapy, including estrogen replacement therapy
  • No previous treatment with CNS radiation
Female
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681928
07006, P30CA033572, CHNMC-07006, CDR0000589001
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Arti Hurria, MD Beckman Research Institute
City of Hope Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP