Clinical Trials

39 studies in Women's Health

1. Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer Rochester, MN View Summary
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   Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced magnetic resonance imaging (MRI) that are predictive of pathologic remissions and survival in women with stage III breast cancer. - Identify two groups of patients who have statistically different 3-year disease-free survival using MRI measurements of tumor response to neoadjuvant chemotherapy. - Determine whether MRI measurements of tumor response after the first course of neoadjuvant chemotherapy can predict which of these patients will ultimately have poor clinical response to chemotherapy. - Compare the accuracy of MRI vs mammography in predicting the extent of residual disease as determined by histopathology in these patients. - Determine whether initial MRI tumor characteristics (morphologic and vascular patterns) predict pathological response and/or survival in these patients. - Estimate the conditional probability of response to paclitaxel based on MRI measurements of response to doxorubicin and cyclophosphamide in these patients. OUTLINE: This is a multicenter study. Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopy of the breast within 4 weeks before beginning neoadjuvant chemotherapy, 20-28 hours or 48-96 hours after the first course of doxorubicin and cyclophosphamide (Type 1 chemotherapy), between Type 1 chemotherapy and paclitaxel chemotherapy regimens (Type 2 chemotherapy) (MRI only) if the patient continues to Type 2 chemotherapy, and 3-4 weeks after final neoadjuvant chemotherapy treatment (1-2 weeks before surgery). Patients also undergo mammograms and possibly ultrasounds that coincide with the first and last MRI. Core or needle biopsy is performed after the first MRI but before the first course of Type 1 chemotherapy and between Type 1 chemotherapy and Type 2 chemotherapy (if the patient continues to Type 2 chemotherapy). Patients are followed every 6 months for 7-10 years. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.

   NCT ID:

   NCT00043017

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - Mayo Clinic Cancer Research Consortiu 507-538-7623
                       
   
   
   

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2. Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To Determine the minimal biologic dose of lapatinib ditosylate, defined as the smallest dose, when compared with placebo, that results in a statistically significant lower rate of proliferation in ductal carcinoma in situ (DCIS) breast cancer cells as measured by Ki67. II. To determine the toxicity profile and frequency of adverse events in women with DCIS breast cancer taking lapatinib ditosylate at three doses (750 mg, 1,000 mg, and 1,500 mg) as compared with women taking placebo. SECONDARY OBJECTIVES: I. To determine whether lapatinib ditosylate treatment affects the incidence of DCIS seen at the time of surgical excision. II. To determine whether treatment with lapatinib ditosylate will modulate breast tissue histology or the expression of specific biomarkers in normal and DCIS breast cancer cells, including proliferation markers (Ki67 in normal cells), apoptosis marker (cleaved caspase 3), growth factor receptors (EGFR, ErbB2, ErbB3, ErbB4), signal transduction markers (MAPK, phospho-MAPK), hormone receptors (estrogen receptor, progesterone receptor), and p27. OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive 1,000 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive 750 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity. Arm IV: Patients receive oral placebo once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity. All patients then undergo surgery. Tissue samples from initial breast biopsy and subsequent excisional biopsy are collected for the following biomarker studies: proliferation by measuring Ki67 staining in ductal carcinoma in situ (DCIS) breast cancer cells; proliferation in normal cells; apoptosis marker (cleaved caspase 3) expression and activation; phospho-MAPK activation by immunohistochemistry (IHC); total MAPK expression; peptide growth factor receptors (ErbB1 [EGFR], ErbB2 [HER-2/neu], ErbB3, ErbB4) expression; estrogen receptor and progesterone receptor proliferation and differentiation; and p27 activation. After completion of study treatment, patients are followed for 4-5 weeks.

   NCT ID:

   NCT00555152

   IRB Number:

   09-001014

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   Who can I contact for additional information about this study?

   
   Scottsdale: Sandhya Pruthi
                       
   
   

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3. Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer Rochester, MN View Summary
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   Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - To study in vivo detection of breast masses by vibro-acoustography (VA) imaging. - To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5. OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.

   NCT ID:

   NCT00627614

   IRB Number:

   284-06

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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4. Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline Rochester, MN View Summary
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   Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - To examine the changes in the plasma concentrations of the hydroxylated metabolite, 4-hydroxy tamoxifen, and endoxifen in women with known or at high risk for developing breast cancer who are receiving selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy comprising venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride for the treatment of hot flashes, depression, or any other medically indicated condition. - To evaluate whether genetic variants known to affect the activity of CYP2D6, SULT1A1, and other drug metabolizing enzymes (e.g., UGT's) involved in the biotransformation of tamoxifen citrate affect the plasma concentrations of the hydroxylated metabolites, 4-hydroxy tamoxifen and endoxifen. OUTLINE: This is a multicenter study. Patients receive oral tamoxifen citrate and concurrent selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) therapy comprising oral venlafaxine, citalopram hydrobromide, escitalopram oxalate, sertraline hydrochloride, or gabapentin for 8-24 weeks. Treatment continues in the absence of disease progression. Blood samples are obtained at baseline and after completion of study therapy. Samples are evaluated by pharmacokinetic analysis to determine the effects of SSRI/SNRI study drugs on plasma concentrations of tamoxifen and its metabolites. Plasma levels of tamoxifen citrate, N-desmethyl tamoxifen, 4-OH tamoxifen, and endoxifen are measured using reverse phase high performance liquid chromatography. Blood samples are also analyzed by CYP2D6 genotyping to test for CYP2D6 gene variation (i.e., *3, *4, *6, *10, *17, and *41) in genes that encode tamoxifen-metabolizing enzymes. Additional CYP2D6 alleles, including gene duplication and gene deletion (*5) are assessed.

   NCT ID:

   NCT00667121

   IRB Number:

   07-006133

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   Who can I contact for additional information about this study?

   Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                       
   
   
   

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5. Detection of Aggressive Breast Tumors Using Tc-99m-NC100692 Rochester, MN View Summary
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   Detection of Aggressive Breast Tumors Using Tc-99m-NC100692

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.

   NCT ID:

   NCT00888589

   IRB Number:

   08-001022

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6. Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS) Rochester, MN View Summary
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   Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent < 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.

   NCT ID:

   NCT00890994

   IRB Number:

   08-005522

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7. Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma. Secondary - To determine if treatment with combination paclitaxel and carboplatin does not result in an inferior progression-free survival when compared to paclitaxel and ifosfamide. - To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin is reduced compared to that of paclitaxel and ifosfamide. - To determine if treatment with combination paclitaxel and carboplatin is associated with superior patient reported quality of life and neurotoxicity scores compared to that of paclitaxel and ifosfamide. Tertiary - To bank formalin-fixed and paraffin-embedded tumor tissue and DNA extracted from whole blood specimens for future research. OUTLINE: Patients are stratified according to history of pelvic radiation (any vs none), disease status/stage at time of study registration (stage I-II [pelvic lymph nodes not surgically and pathologically assessed] vs FIGO stage I-II [pelvic lymph nodes surgically and pathologically assessed] vs FIGO stage III-IV vs recurrent), and measurable disease (any vs none). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. - Arm II: Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3. In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity. Archival formalin-fixed and paraffin-embedded tumor tissue samples and a pre-treatment blood sample are collected for further analysis. Patients also complete quality of life (FACT-G, FACT-En TOI) and neurotoxicity (FACT/GOG-Ntx subscale) assessments at baseline and at weeks 6, 15, and 26. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

   NCT ID:

   NCT00954174

   IRB Number:

   09-006613

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   

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8. Veliparib With or Without Carboplatin in Treating Patients With Stage III or Stage IV Breast Cancer Jacksonville, FL Rochester, MN View Summary
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   Veliparib With or Without Carboplatin in Treating Patients With Stage III or Stage IV Breast Cancer

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To evaluate the efficacy of single agent ABT-888 (veliparib) (NSC 737664) in BRCA carriers with metastatic breast cancer based on response rate (RECIST criteria). SECONDARY OBJECTIVES: I. To conduct subset analysis on BRCA1 vs. BRCA2 and hormone receptor status. II. To evaluate progression-free survival of patients on single-agent ABT-888. III. To further describe the safety and tolerability of ABT-888 (NSC 737664) as a single agent and in combination with carboplatin for BRCA-associated breast cancer. IV. To evaluate the pharmacokinetics of ABT-888 (NSC 737664) alone and in combination with carboplatin. V. To assess the relationship between the level of PARP inhibition by ABT-888 and biomarkers of DNA damage in PBMC's and in tumor VI. To explore the relationship between biomarkers of drug effect and progression-free survival. VII. To evaluate the efficacy and safety of the combination of carboplatin and ABT-888 in patients who have failed single agent ABT-888. VIII. To conduct subset analysis on BRCA1 vs. BRCA2 and hormone receptor status. OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), and hormone status (estrogen receptor [ER]- and/or progesterone receptor [PR]-positive vs ER- and/or PR-negative). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral veliparib twice daily on days 1-21. ARM II: Patients receive carboplatin IV over 30 minutes on day 1 and veliparib as in arm I. In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and hair follicle sample collection for pharmacokinetics and other laboratory studies. After completion of study therapy, patients are followed up every 3-6 months.

   NCT ID:

   NCT01149083

   IRB Number:

   10-004887

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   Who can I contact for additional information about this study?

   Rochester: Matthew P. Goetz 507-284-2511
                       
   Scottsdale: Donald W. Northfelt 480-301-4411
                       
   Jacksonville: Edith A. Perez 904-953-7283
                       
   

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9. I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Rochester, MN View Summary
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   I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a high Bayesian predictive probability of being more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing are graduated or dropped.

   NCT ID:

   NCT01042379

   IRB Number:

   09-008628

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   Who can I contact for additional information about this study?

   Rochester: 507-538-7623
                       
   
   
   

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10. Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions Rochester, MN View Summary
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    Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    A total of 150 patients will be studied. Each patient will have a suspicious lesion on mammogram, ultrasound or breast magnetic resonance imaging (MRI) for which biopsy is scheduled. The lesion size on mammogram, ultrasound or breast MRI must be less than 2 cm in diameter and must be considered "suspicious" or "highly suspicious" for malignancy. Following injection of 8 mCi Tc-99m sestamibi, all patients will undergo craniocaudal (CC) and mediolateral oblique (MLO) views of each breast using a molecular breast imaging (MBI) system incorporating the latest hardware and software algorithms. Each image will be acquired for 10 minutes in dynamic mode as 4 x 2.5 minute images. Summation of a given number of frames from each acquisition will yield images of an increasing mCi dose. Hence with an 8 mCi injection and a dynamic acquisition mode, we can evaluate the sensitivity of MBI as a function of administered doses of Tc-99m sestamibi ranging from 2 to 8 mCi. The thickness of the breast will be recorded to determine its relevance to lesion detectability. Patient Selection The goal of this study is to enroll 150 female patients in this study. The rationale for a study number of 150 patients is given in Appendix D. Patients referred for a mammogram, ultrasound or breast MRI study at Mayo Clinic Rochester will be considered for the study if they meet the following criteria: - Have a lesion on mammogram, ultrasound or breast MRI that measured < 2 cm and is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BI-RADS 4 or 5). (Note: while 2 cm is larger than the desired lesion size that we wish to study, this limit was recommended by our radiology colleagues as estimates of lesion size from mammography, ultrasound and MRI are not exact) - Are scheduled for biopsy (needle and/or surgical biopsy) of the suspicious lesion - Are > 18 years of age - Had a negative pregnancy test or must be postmenopausal or surgically sterilized Eligible patients will be offered enrollment if the time interval between mammogram, ultrasound or MRI and scheduled biopsy allows for performance of MBI. Patients with prior needle biopsy of the lesion will be excluded from this study, as such biopsies may effectively remove all or part of the lesion. Prospective patients will be identified by the radiologist based on findings in their mammographic, ultrasound or MRI studies.

    NCT ID:

    NCT01285440

    IRB Number:

    10-000748

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