Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer

• Status: Completed
• Trial end date: 2014-06-06
• Target enrollment: 0
• Participant gender: Female

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.

PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women with newly diagnosed early-stage breast cancer.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aromatase Inhibitors; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Estrogens; Fluorodeoxyglucose F18; Liposomal doxorubicin; Progesterone; Trastuzumab

Criteria

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