Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
NCT ID: NCT00755313
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2007-05-31
2014-06-06
Brief Summary
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PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women with newly diagnosed early-stage breast cancer.
Detailed Description
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Primary
* To prospectively evaluate the acute (1 month after chemotherapy) and relatively long-term (18 months after chemotherapy) effects of standard-dose chemotherapy and/or hormonal therapy with aromatase inhibition on brain function using positron emission tomography (PET) and the glucose metabolism tracer fludeoxyglucose F 18 in women with newly diagnosed, early stage breast cancer.
Secondary
* To evaluate the acute and relatively long-term effects of chemotherapy and/or hormonal therapy on MRI measurements of hippocampal volume, cortical grey matter volume, white matter signal hyperintensities, ventricular volume, and whole brain volume in these patients.
* To evaluate the acute and relatively long-term effects of chemotherapy and/or hormonal therapy with aromatase inhibition on cognitive function in these patients.
* To explore the characteristics of these patients that renders them more vulnerable to chemotherapy and/or estrogen suppression-induced cognitive decline.
OUTLINE: Patients are stratified according to planned adjuvant chemotherapy (chemotherapy and hormonal therapy vs hormonal therapy vs chemotherapy vs no therapy) and the hormone receptor status (positive vs negative).
Patients (groups A-C) undergo bioavailable estradiol measurements, PET scans, and MRI scans at baseline and 1 and 18 months after treatment. Patients also undergo cognitive, neuropsychological, sociodemographic, and quality of life assessments using a battery of study tests and questionnaires at baseline and at 1, 9, and 18 months after treatment. Group D participants (controls) undergo the same testing at equivalent intervals.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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trastuzumab
aromatase inhibition therapy
carboplatin
cyclophosphamide
docetaxel
doxorubicin hydrochloride
metabolic assessment
questionnaire administration
study of socioeconomic and demographic variables
cognitive assessment
positron emission tomography
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer, meeting 1 of the following criteria:
* Group A
* Stage I, II, or III invasive disease
* Hormone receptor-positive disease
* Planned adjuvant chemotherapy including an anthracycline and taxane using either dose-dense or docetaxel, doxorubicin hydrochloride, and cyclophosphamide (TAC) regimens with or without trastuzumab (Herceptin®) for 4 months; docetaxel and cyclophosphamide (TC) with or without trastuzumab for 3 months; doxorubicin hydrochloride and cyclophosphamide (AC) for 3 months; or doxorubicin hydrochloride, carboplatin, and trastuzumab (TCH) for 4 months (trastuzumab may be given for 1 year and is not considered chemotherapy for the purpose of this study)
* Planned treatment with adjuvant aromatase inhibitors (AI) for 5 years
* Group B
* Stage I or II invasive disease
* Planned treatment with adjuvant AI with or without radiotherapy
* Group C
* Stage I, II, or III disease
* Hormone-receptor negative
* Planned adjuvant chemotherapy as in group A
* No treatment with AI planned
* Group D
* Healthy controls free of any major medical or psychiatric disorders
* Not taking prescription medications, including hormone-replacement therapy, or other substances that might influence performance on neuropsychological tests
* Balanced with the patient groups on age, education, ethnicity, and sociodemographic background
PATIENT CHARACTERISTICS:
* No history of psychiatric illness other than minor depression
* No history of psychiatric illness other than minor depression in immediate family members
* No history of neurologic disease
* No history of drug or alcohol abuse
* No significant medical illness other than breast cancer
* No heart pacemaker or metallic implants or particles in the body
* No heart rhythm disturbance
* No claustrophobia
* No prior serious head injury
* No tattoos or permanent cosmetics
* No unremovable body jewelry
* No cognitive impairment
* Able to read and speak English
* No condition that compromises compliance with the objectives and procedures of this study, as judged by the principal investigator
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy, CNS radiotherapy, or intrathecal therapy
* Premenopausal women receiving aromatase inhibitors must also be receiving ovarian suppression
* No concurrent narcotics or major antipsychotic medications that may impair cognition
35 Years
80 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Hope S. Rugo, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-06803
Identifier Type: -
Identifier Source: secondary_id
UCSF-H6961-29940-02B
Identifier Type: -
Identifier Source: secondary_id
CDR0000613050
Identifier Type: -
Identifier Source: org_study_id