Breast Cancer

Clinical Trials

Below is a list of Breast Cancer clinical trials from the clinical trials database at Mayo Clinic.

Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
OBJECTIVES: Primary - To compare invasive disease-free survival of patients with early-stage breast cancer treated with metformin vs placebo in addition to standard adjuvant therapy. Secondary - To compare overall survival of these patients.
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Background: - The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining genomic stability by regulating a variety of DNA repair mechanisms. - Individuals with deleterious mutations in the BRCA1 or BRCA2 tumor suppressor genes have an increased risk of developing breast and ovarian cancers due to impaired or defective DNA damage repair; these individuals have an increased susceptibility to DNA-damaging agents and PARP
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Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast.
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Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer
OBJECTIVES: Primary - To evaluate objective response rate by RECIST criteria of the combination of azacitidine (5-AZA) and entinostat in women with advanced triple-negative or hormone-refractory breast cancer. Secondary - To determine the safety and tolerability of the combination of 5-AZA and entinostat in women with advanced breast cancer.
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Bicalutamide in Treating Patients With Metastatic Breast Cancer
OBJECTIVES: Primary - Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer. Secondary - Determine the 6-month progression-free survival of patients treated with this drug.
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Capecitabine and Lapatinib With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
OBJECTIVES: Primary - To compare the progression-free survival of patients with HER2-positive stage IIIB, IIIC, or IV breast cancer treated with lapatinib ditosylate and capecitabine with vs without cixutumumab. Secondary - To assess the safety and tolerability of these regimens in these patients.
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Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
OBJECTIVES: Primary - To establish the recommended dose level of cixutumumab and temsirolimus for the phase II study in patients with metastatic breast cancer. (Phase I) - To examine the safety profile of this combination in patients with metastatic breast cancer.
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Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
OBJECTIVES: Primary - To compare the pathologic complete response rate (pCR) within the breast of patients with breast cancer receiving neoadjuvant combination chemotherapy comprising fluoroucacil, epirubicin hydrochloride, and cyclophosphamide followed by paclitaxel and trastuzumab vs neoadjuvant paclitaxel with trastuzumab (Herceptin®) followed by combination chemotherapy comprising fluoroucacil, epirubicin hydrochloride, cyclophosphamide, and trastuzumab.
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Combination Chemotherapy Followed By Docetaxel or Ixabepilone in Treating Patients Who Have Undergone Surgery for Nonmetastatic Breast Cancer
OBJECTIVES: Primary - To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.
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Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo.
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Detection of Aggressive Breast Tumors Using Tc-99m-NC100692
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.
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Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
OBJECTIVES: - Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).
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Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging
The study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact MBI images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.
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Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Pre-Menopausal Women with Endocrine Responsive Breast Cancer (IBCSG 24-02)
This research study is being done to:

• see if ovarian function suppression [OFS] plus giving tamoxifen or exemestane is better at stopping the return of breast cancer than just giving tamoxifen in pre-menopausal women.
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  Evaluation of SAMe for Hot Flashes
  OBJECTIVES: I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
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  Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
  OBJECTIVES: - To investigate the role of genotypes for carcinogen metabolizing enzymes (CME) and DNA repair proteins(DRPs) of the father of children diagnosed with retinoblastoma (RB) and his environmental exposures prior to the child's conception in the etiology of sporadic bilateral retinoblastoma.
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  Genetics Study for Women with Breast Cancer and Starting Anastrozole (Arimidex) Treatment (MC0532)
  This study is being done to examine how a woman's genes affect the way her body responds to anastrozole treatment. Researchers will look at changes in hormone levels, bone density and mammograms.
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  Higher-Dose Radiation Therapy or Standard Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
  OBJECTIVES: Primary - To determine whether an accelerated course of hypofractionated whole-breast irradiation (WBI) including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients.
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  I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
  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.
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  Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast
  OBJECTIVES: Primary - 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.
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  Letrozole in Treating Healthy Postmenopausal Women at High Risk for Breast Cancer
  OBJECTIVES: Primary - To compare the effect of lower and intermittent doses of letrozole to standard letrozole therapy on estrogen suppression in postmenopausal women at high risk for developing breast cancer. Secondary - To compare the effect of lower and intermittent doses of letrozole to standard therapy on signs and symptoms of estrogen deficiency, including menopausal symptoms, serum lipid profile, and serum marker bone turnover.
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  Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
  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.
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  Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
  The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (~90%) for the detection of breast cancers independent of breast density.
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  Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
  OBJECTIVES: Primary - To compare the progression-free survival of patients with stage IIIC or IV breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) versus ixabepilone versus paclitaxel with or without bevacizumab. Secondary - To compare the objective response rate, duration of response, and time to treatment failure in patients receiving nab-paclitaxel versus paclitaxel, and to separately compare these endpoints in patients receiving ixabepilone versus paclitaxel.
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  Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
  OBJECTIVES: Primary - To assess the proportion of confirmed tumor responses in patients with HER2-negative metastatic breast cancer treated with pixantrone dimaleate. Secondary - To describe the distribution of progression-free survival (PFS) times of patients treated with this drug.
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  Radiation Therapy in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
  OBJECTIVES: Primary - Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy. Secondary - Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
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  Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
  OBJECTIVES: Primary - Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk. Secondary - Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes
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  Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
  The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
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  Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
  The purpose of this pilot study is to obtain preliminary data on a new way of imaging the breast that combines the benefits of a 3-D anatomical technique (Digital Tomosynthesis) with those of a functional imaging technique (Molecular Breast Imaging).
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  Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
  OBJECTIVES: Primary - To determine the effect of endocrine therapy with versus without chemotherapy in patients with node-positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. Secondary - To compare overall survival (OS), distant disease-free survival (DDFS), and local disease-free interval (LDFI) by receipt of chemotherapy or not and its interaction with RS.
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  Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
  Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders, a surgical site infection involving the implant can result in its removal and a failed reconstruction.
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  Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions
  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.
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  Veliparib With or Without Carboplatin in Treating Patients With Stage III or Stage IV Breast Cancer
  OBJECTIVES: Primary - To determine the efficacy of veliparib with vs without carboplatin in patients with stage III or IV BRCA-associated breast cancer. - To evaluate the progression-free survival of patients treated with these regimens.
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  Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer
  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.
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  Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women
  OBJECTIVES: - To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging. - To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast.
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  Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
  OBJECTIVES: Primary - To determine the maximum-tolerated dose of Z-endoxifen hydrochloride in women with metastatic estrogen-receptor positive (ER+) breast cancer. - To describe the safety profile of Z-endoxifen hydrochloride at each of the doses examined.
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  Z1031, A Phase 3 Trial Comparing 16 to 18 Weeks of Neoadjuvant (Given Before Surgery) Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Stage 2 and 3 Estrogen Receptor Positive Breast Cancer
  Patients are being asked to take part in this study because they have a kind of breast cancer that is affected by the levels of hormones in their body. Patients are also postmenopausal, which can affect the way this kind of cancer responds to certain kinds of treatment.
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  Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
  OBJECTIVES: Primary - To compare the proportion of patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related event during 2 years of treatment with zoledronic acid administered every 12 weeks vs every 4 weeks.
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