OBJECTIVES:

1. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:
   • Hormonal and growth factor status (follicle stimulating hormone; total, bound and free estradiol; androgens; sex hormone-binding globulin; thyroid hormones; prolactin;
   insulin-like growth factors I and II; and plasma leptin).
   • Factors affecting energy intake or expenditure (oral intake, physical activity and resting metabolic rate).
   • Psychological factors (depression and quality of life).
2. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.
3. Assess the impact of chemotherapy on bone marrow density in these patients.

PARTICIPATION CRITERIA

• Age: 18 to 80
• Menopausal status: Premenopausal or postmenopausal
• Histologically proven newly diagnosed stage I, II or resectable IIIA primary breast cancer
• Scheduled to receive chemotherapy
• No prior oophorectomy

PROTOCOL
Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (I) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (II) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (III) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits “a” and “b” during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.

STUDY CONTACT:
Noreen Aziz, Ph: 301-496-0598
Cancer Prevention Studies Branch
Bethesda, Maryland

OBJECTIVES:

1. Evaluate the safety of hormone replacement therapy in terms of risk of recurrence in women with previously treated, nonrecurrent stage O-II breast cancer.
2. Compare this regimen with non-hormonal symptomatic treatment in terms of quality of life and risk of death in this patient population.

PARTICIPATION CRITERIA

• Menopausal or perimenopausal
• Hormone receptor status: positive, negative, or unknown
• History of stage O-II breast cancer with no more than four involved axillary nodes if nodal status and number of nodes investigated is known
• Currently without evidence of disease
• No concurrent chemotherapy
• Prior hormone replacement therapy (HRT) allowed if stopped no more than 4 weeks after breast cancer diagnosis and at least 3 months prior to study
• No prior HRT begun after breast cancer diagnosis
• No concurrent hormonal therapy for breast cancer except tamoxifen or Toremifene
• No concurrent radiotherapy

STUDY CONTACT:
C. Rageth, Ph: 0041 1 733 21 76
International Breast Cancer Study Group,
Spital Limmattal, Switzerland

OBJECTIVES:

1. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy.
2. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients.
3. Validate or refute the use of an algorithm using pre-and post-treatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients.
4. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa
   compared to those who receive placebo.

PARTICIPATION CRITERIA

• Age: 18 and over
• Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL
• Histologically confirmed advanced malignancy
• Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer

PROTOCOL
Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (Arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (Arm II).

STUDY CONTACT
Thomas E. Witzig, Chair Ph: 507-284-2176
North Central Cancer Treatment Group

OBJECTIVES:

1. Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II, III, or IV breast cancer.
2. Determine behavioral mechanisms that may mediate the ffects of stress reduction on survival in these patients.
3. Determine baseline variables that contribute to predicting survival time in these patients.

PARTICIPATION CRITERIA

• Age: 55 and over
• Hormone receptor status: Not specified
• Diagnosis of stage II, III, or IV breast cancer
• No brain or CNS metastases

STUDY CONTACT
Rhoda Pomerantz, Ph: 773-665-3606
St. Joseph Health Centers & Hospital
Chicago, Illinois

OBJECTIVES:

1. Compare the effect of two different methods of providing education to persons enrolling in a breast cancer genetics program.

PARTICIPATION CRITERIA
Diagnosis of breast cancer or ductal carcinoma in situ at age 45 or under OR Diagnosis of ovarian cancer at age 50 or under OR Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer and ovarian cancer in the same individual OR Diagnosis of breast or ovarian cancer AND At least one first- or second-degree relative with breast cancer diagnosed at age 45 or under or ovarian cancer at age 50 or under OR Three relatives in the same lineage with breast or ovarian cancer where each affected individual is a first- or sec-ond- degree relative to another of the affected individuals OR First- or second-degree male relative with breast cancer diag-nosed at any age OR Women of Ashkenazi Jewish descent who meet any of the above criteria with specified ages of onset of 50 for breast cancer and any age for ovarian cancer OR Male with breast cancer diagnosed at any age OR Documented BRCA mutation in the family.

PROTOCOL
This is a randomized study. Participants are randomized to one of two different education methods.

All participants complete a pretest questionnaire, then attend a breast cancer genetics education and counseling session. A post test questionnaire is also completed.
Participants may then choose to undergo germline BRCA testing.

Participants are followed at 1 week and 3, 6, and 12 months after receiving results of BRCA germline testing.

STUDY CONTACT
Ilan R. Kirsch, Chair Ph: 301-496-4345
Center for Cancer Research

OBJECTIVES:

1. Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
2. Compare quality of life, anxiety, and depression in patients treated with these regimens.

PARTICIPATION CRITERIA

• Diagnosis of breast cancer
• Experiencing 2 or more hot flashes per day for at least 1 week
• No concurrent clonidine or venlafaxine

STUDY CONTACT
Kishan J. Pandya, Chair Ph: 716-275-9319
University of Rochester Cancer Center

OBJECTIVES:

1. Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen.
2. Determine the effect of this regimen on blood coagulation and lipid profiles in these patients.
3. Determine the quality of life of patients treated with this regimen.

PARTICIPATION CRITERIA

• Postmenopausal females, 18 and over
• No menstrual period for more than 12 months OR prior bilateral oophorectomy
• Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy
• Node-negative invasive or ductal carcinoma in situ of the breast
• No contralateral breast cancer
• No recurrent or metastatic disease
• Completion of active non-hormonal therapy for breast cancer
• Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study
• Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR vaginal symptoms
• No active endometriosis or unexplained vaginal bleeding

STUDY CONTACT
Melody A. Cobleigh, Chair Ph: 312-942-3240
Eastern Cooperative Oncology Group