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| ID | Type | Description | Link |
|---|---|---|---|
| UCSF-06803 | |||
| UCSF-H6961-29940-02B |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering information over time from laboratory tests, imaging scans, and assessment tests may help doctors learn more about the side effects of chemotherapy and plan the best treatment.
PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women with newly diagnosed early-stage breast cancer.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | |||
| aromatase inhibition therapy | Drug | |||
| carboplatin | Drug | |||
| cyclophosphamide | Drug | |||
| docetaxel | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| metabolic assessment | Other | |||
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose metabolism | Up to 18 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MRI measures of the brain (hippocampal volume, cortical gray matter volume, white matter signal hyperintensities, ventricular volume, whole brain volume) | Up to 18 months after treatment | |
| Measures of cognitive function over time by Wechsler memory scale, word list memory, Stroop Color Word Test, Boston Naming Test, verbal fluency, FACIT-B functional assessment, Mini Mental State Exam, Hamilton Depression Rating Scale (Ham-D), Beck De ... |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer, meeting 1 of the following criteria:
Group A
Group B
Group C
Group D
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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women with newly diagnosed, early stage breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Hope S. Rugo, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
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| questionnaire administration |
| Other |
| study of socioeconomic and demographic variables | Other |
| cognitive assessment | Procedure |
| positron emission tomography | Procedure |
| fludeoxyglucose F 18 | Radiation |
| Up to 18 months after treatment |
| Cognitive assessments over time by FACIT-B, Ham-D, BDI-II, STAI, FSI, and MASQ, demographic and medical data | Up to 18 months after treatment |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D047072 | Aromatase Inhibitors |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| D000073216 | Mental Status and Dementia Tests |
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
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