Status:
COMPLETED
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chemotherapeutic Agent Toxicity
Eligibility:
FEMALE
35-80 years
Brief Summary
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. P...
Detailed Description
OBJECTIVES: 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 t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 6 2014
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00755313
Start Date
May 1 2007
End Date
June 6 2014
Last Update
November 24 2017
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115