PROTOCOL IDS: KUMC-7813-99, NCI-P00-0158, KUMC-HSC-7419-98

PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.

OBJECTIVES

1. Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.

PARTICIPATION CRITERIA

• Histologically confirmed noninvasive or small invasive breast cancer
• Low or intermediate grade (ductal carcinoma in situ, T1 or T2) OR
• Estrogen and/or progesterone receptor-positive
• Largest mass no greater than 5 cm
• Clustered microcalcifications as only abnormality allowed with no upper size limit
• If no distinction between mass and microcalcifications, size as 1 lesion
• No evidence of metastases from any malignancy
• 18 and older
• Postmenopausal
• At least 1 year since chemotherapy, prior aromatase inhibitors, antiestrogens or LH agonists/antagonists
• No concurrent hormone replacement therapy or oral contraceptives
• Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study

STUDY CONTACT

Carol J. Fabian, Chair Ph: 913-588-7791
University of Kansas Medical Center

PROTOCOL IDS: NCI-99-C-0081, MB-NAVY-B99-015, NCI-NMOB-9811

PROJECTED ACCRUAL: A total of 120 participants (60 per arm) will be accrued for this study within 18-24 months.

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 second-degree relative to another of the affected individuals OR First- or second-degree male relative with breast cancer diagnosed 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

Pamela Klein, Ph: 301-295-3899
Division of Clinical Sciences, Medicine Branch
Bethesda, Maryland

PROTOCOL IDS: TXS-G990184, NCI-V00-1643, DFCI-99029, MDA-ID-99137, TXS-1999-P-009925/10

PROJECTED ACCRUAL: A total of 15 patients.

1. Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
2. Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure.
3. Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients following this procedure.
4. Determine patient acceptance of this procedure in terms of positioning, pain, safety, and follow-up cosmesis.

PARTICIPATION CRITERIA

• Histologically confirmed invasive breast cancer (T1, N0-2, M0)
• Single focal lesion no greater than 3.5 cm in diameter by MRI
• No lesions difficult to target, defined as less than 1 cm from skin, nipple, or rib cage
• No microcalcifications as sole sign of disease
• No extensive intraductal components on core biopsy
• No breast implants
• At least 3 months since prior chemotherapy
• Concurrent hormone replacement therapy allowed, concurrent tamoxifen allowed
• No concurrent steroids
• No prior external radiotherapy or laser therapy to ipsilateral breast

PROTOCOL

Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam, and guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy. Patients are followed at 5-10 days post-surgery.

STUDY CONTACT

Pamela Klein, Ph: 301-295-3899
Division of Clinical Sciences, Medicine Branch
Bethesda, Maryland

PROTOCOL IDS: ROC-HABITS, EU-98077

PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study over 5-6 years.

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
See PDQ for other investigators

PROTOCOL IDS: UCLA-9810046, NCI-G00-1724, UCSD-985772

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study over 2.5 years.

1. Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence, progression, or death among different racial groups in premenopausal women with stage I, II, or III breast cancer.
2. Determine if definitive breast cancer surgeries (e.g., lumpectomy or mastectomy) performed during the follicular phase result in poorer prognosis (recurrence, disease progression, or death) compared with surgeries performed during the midcycle or luteal phases in this patient population.

PARTICIPATION CRITERIA

• Premenopausal
• Hormone receptor status: Not specified
• Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery
• Invasive disease (e.g., lobular or ductal), no bilateral disease no distant metastases
• Regular menses (no amenorrhea of greater than 90 days) without hormone replacement
• Documented last menstrual period
• No preoperative chemotherapy
• No concurrent hormonal replacement therapy
• No concurrent interruptive oral contraceptive use of less than 3 months

PROTOCOL

This is a multicenter study. Patients undergo either fine needle aspiration concurrently with definitive breast surgery (mastectomy or lumpectomy) or needle directed excisional biopsy followed by definitive breast surgery. Patients undergo serum collection for hormonal analysis preoperatively, 24 hours post operatively, at days 7 and 14, and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses.

Patients complete a 30 minute telephone interview regarding medical, family, occupational, and reproductive history, and lifestyle habits (e.g., diet, exercise, environmental exposures). Beginning 24 hours prior to surgery and continuing until the onset of the next menses, patients complete a menstrual cycle journal indicating the start and length of menses.

Patients undergoing mastectomy are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. Patients undergoing adjuvant therapy are followed every 3 months for 3 years, and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter.

STUDY CONTACT

Helena R. Chang, Ph: 310-794-5624
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California

PROTOCOL IDS: SJHCH-TM1, NCI-V00-1618

PROJECTED ACCRUAL: Approximately 166 patients (83 per treatment arm) will be accrued for this study over 1.5 year.

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 effects 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

PROTOCOL IDS: NCCTG-N9431

PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study. Approximately 90 patients are expected to undergo two stages of surgery that do not occur within the same phase of the menstrual cycle.

1. Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual history in premenopausal women at the time of primary surgery for stage I/II breast cancer.
2. Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients.
3. Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record.
4. Compare the menstrual cycle data for these women (i.e., hormone levels and cycle history) with the data for the general population.
5. Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase.

PARTICIPATION CRITERIA

• Age: 18 to 55
• Premenopausal
• Hormone receptor status: Not specified
• Pathologically confirmed stage I/II breast cancer
• No prior neoadjuvant therapy
• Concurrent chemotherapy allowed At least 3 months since oral contraceptives
• Concurrent radiotherapy allowed
• Complete surgical resection required prior to entry
  • One or two stage procedure (i.e., open biopsy followed immediately or later by mastectomy or breast-conserving approach)
  • Two-step registration required for patients undergoing two-stage procedure
  • Fine needle aspiration (FNA), stereotactic, or core needle biopsy is allowed at any time prior to open biopsy
  • Sentinel node dissection/axillary node dissection allowed.

PROTOCOL

This is a multicenter study. Hormone levels and menstrual history are obtained within one calendar day to surgery. Patients undergo either one-stage surgery (open biopsy followed by mastectomy or breast conserving surgery) or two-stage surgery.

Patients complete a questionnaire 6 months after surgery to assess the extent of adjuvant therapy received (if any), and a questionnaire 12 months after surgery to assess recurrence of breast cancer and vital status. Patients are followed annually thereafter for 10 years.

STUDY CONTACT

Clive S Grant, Chair, Ph: 507-284-2644
North Central Cancer Treatment Group

D Lawrence Wickerham, Chair, Ph: 412-330-4600
National Surgical Adjuvant Breast and Bowel Project

PROTOCOL IDS: MCC-12114, NCI-G00-1808, MCC-IRB-549 q

PROJECTED ACCRUAL: A total of 100 patients (50 per arm).

OBJECTIVES

1. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions.
2. Compare the cost-effectiveness of these diagnostic methods in these patients.
3. Demonstrate that radioactive seed localization allows for elimination of specimen X-ray in these patients.
4. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

PARTICIPATION CRITERIA

• Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis OR nonpalpable breast lesion that is not amenable to core biopsy or advanced breast biopsy instrumentation (ABBI) excision.

STUDY CONTACT

Charles E. Cox, Ph: 813-972-8480
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida

PROTOCOL IDS: UPCC-ACR-6883

PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.

1. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations.
2. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients.
3. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast.

PARTICIPATION CRITERIA

• Suspicious mammographic finding or palpable abnormality OR Suspicious clinical or ultrasound finding without associated benign mammographic features
• May have more than one suspicious lesion based on mammography or clinical exam if an index lesion is present
• Mammogram within 2 months prior to MRI scan and copy of films required of all patients 30 years of age and over
• Eligibility maintained if patient meets above criteria and has had: Breast implant, prior benign excisional or core biopsy at least 6 months prior to study, fine needle aspiration performed at any time, cancer in the contralateral breast, no history of prior breast cancer in the study breast

PROTOCOL

This is a multicenter study.

Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed.

Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years.

STUDY CONTACT

Mitchell Schnall, Ph: 215-662-7238
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania

PROTOCOL IDS: NCCTG-N003A

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7-18 months.

1. Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
2. Determine the toxicity profile of this drug in these patients.
3. Determine the time to progression in these patients treated with this drug.
4. Assess these patients' pre f e rences with re g a rd to this oral drug .
5. Determine the quality of life of these patients treated with this drug.
6. Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

PARTICIPATION CRITERIA

• Age 65 and over
• Histologically or cytologically confirmed stage IV breast cancer
• Eligible to receive first- or second-line chemotherapy
• Measurable disease: At least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm in longest diameter. Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy

PROTOCOL

Patients receive oral vinorelbine weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

STUDY CONTACT

Michael J. O'Connell, Chair Ph: 507-284-2511
North Central Cancer Treatment Group

PROTOCOL IDS: NCI-01-C-0009

PROJECTED ACCRUAL: Approximately 200 participants (100 BRCA1/2 mutation carriers and 100 BRCA1/2 mutation non-carriers).

1. Determine whether breast imaging outcome measures in women who are BRCA1 or BRCA2 mutation carriers and non-carriers can be used to define a high-risk imaging phenotype.
2. Assess the use of positron emission tomography imaging of breast lesions detected by mammography or magnetic resonance imaging, normal contralateral breast tissue, and normal ovarian tissue in BRCA1/2 carriers and non-carriers.
3. Assess the use of breast duct lavage to obtain epithelial cell samples for cytologic evaluation and molecular/genetic studies in high-risk premenopausal women.
4. Compare imaging findings with histologic or cytologic findings from these participants.

PARTICIPATION CRITERIA

• Age Range: 18 to 49
• Previous participation on protocol NCI-78-C-0039 or NCI-99-C-0081
• Known carrier or at least a 50% probability of carrying a BRCA1 or BRCA2 mutation
• Must agree to release results of genetic counseling for stratification purposes
• Have undergone genetic counseling and risk assessment
• At least 6 months since prior steroids, selective estrogen receptor modulators, or hormonal agents, including the following: tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, Depoprovera, progestin IUD, oral progestin, Norplant, or drugs to induce ovulation

PROTOCOL

Participants undergo a physical exam including exam of breast and pelvis, standard four-view mammogram, breast magnetic resonance imaging (MRI), CA-125 level determination and transvaginal color doppler ultrasonography.

Participants with abnormal mammogram and/or MRI results are asked to undergo positron emission tomography scans of the breast and asymptomatic ovaries. Breast duct lavage fluid is collected from all participants for cytologic analysis. Participants undergo repeat screening studies annually for 3 years.

STUDY CONTACT

Ruthann M. Giusti, Chair Ph: 301-496-1611
Division of Cancer Epidemiology and Genetics

PROTOCOL IDS: URCC-U2101, NCI-P01-0183

PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

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

PROTOCOL IDS: GENENTECH-AVF2119g, GUMC-00299, MSKCC-01008, UAB-0028, UAB-F001009003

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 12 months.

1. Compare the efficacy of bevacizumab with capecitabine vs capecitabine alone in women with previously treated metastatic breast cancer, as measured by time to disease progression, objective response rate, duration of response, 1-year survival, and duration of survival.
2. Compare the safety of these regimens in these patients.
3. Compare the pharmacokinetics of these regimens in a subset of these patients.
4. Determine the pharmacodynamics of bevacizumab with capecitabine in a subset of these patients.
5. Compare the extent of change in quality of life of patients treated with these regimens.

PARTICIPATION CRITERIA

• Age: 18 and over
• Histologically confirmed progressive metastatic breast cancer
• Previously treated with 1-2 conventional chemotherapy regimens for metastatic disease
• Previously treated with both an anthracycline (or anthracenedione) and taxane OR
• No prior chemotherapy for metastatic disease if previously treated with an adjuvant anthracycline (or anthracenedione) and taxane regimen and if relapse occurred within 12 months of completing adjuvant therapy
• Bidimensionally measurable disease
• No HER2-positive disease (3+ by immunohistochemistry or positive by FISH) unless previously relapsed after trastuzumab (Herceptin)

PROTOCOL

Arm I: Oral capecitabine twice daily on days 1-14.

Arm II: Chemotherapy as in arm I plus bevacizumab IV over30-90 minutes on day 1.

Treatment repeats in both arms every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease in arm II may continue to receive bevacizumab alone or in combination with a new chemotherapy regimen or other treatment.

STUDY CONTACT

Ginny Langmuir, Chair Ph: 650-225-4985
Genentech Inc.

PROTOCOL IDS: NCCTG-979253, NCI-P98-0133

PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study over 11 months.

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

PROTOCOL IDS: CHNMC-PHI-08, NCI-T96-0028H, LAC-USC-PHI-08

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.

1. Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction.
2. Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy.
3. Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients.

PARTICIPATION CRITERIA

• Age 18 and over
• Solid tumor that is refractory to standard therapy or for which no standard therapy exists
• Eligible tumors, include, but are not limited to, the following:
• Breast
• Ovarian
• Head and neck
• Non-small cell lung cancer
• Abnormal liver function
• Control patients with normal liver function are enrolled
• Brain metastases allowed if controlled by radiotherapy or surgery and neurologic status currently stable
• No prior bone marrow transplantation
• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
• At least 4 weeks since prior radiotherapy and recovered (no prior radiotherapy to more than 25% of bone marrow)

PROTOCOL

This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild vs moderate vs severe).

Patients receive docetaxel IV over 1 hour. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR.

Within each abnormal liver function stratum, cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined.

The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Within each abnormal liver function stratum, more than 6 patients are treated at the MTD, if possible. Patients in the normal liver function stratum are included as control patients and are followed for toxicity, but do not undergo dose escalation.

STUDY CONTACT

James H. Doroshow, Chair Ph: 626-359-8111
Beckman Research Institute, City of Hope
Los Angeles, California, U.S.A.