Breast: Metastatic Clinical Trials

Showing 1-30 of 34 items
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  • Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
  • In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • ZK219477 in Patients With Breast Cancer and Brain Metastases
  • The purpose of this research study is to determine the effects (good and bad) of ZK219477 on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
  • Diagnoses: Brain/Neuro Cancer: Other Non-Glioblastoma, Breast: Metastatic
  • Status: Recruiting
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  • Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer
  • Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American women. Metastatic disease including metastatic breast cancer unfortunately remains incurable. One reason is due to the inability to develop specific therapies for specific cancer subsets. The use of modern genomic techniques has significantly enhanced our recent understanding of breast cancer biology. Five distinct breast cancer subsets have been recognized, one of which is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER-2-Neu) negative. This is referred to as triple negative breast cancer or TBNC. TBNC represents a significant proportion of breast cancer patients (10-20%) and has a poor prognosis with no targeted approach to therapy as of yet. Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast cancer cells. Previous studies have shown that combining antibodies with selected chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC patients.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
  • The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • ARQ197 in Metastatic Triple-Negative Breast Cancer
  • This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved ARQ 197 for use in patients, including patients with your type of cancer. ARQ 197 is a drug that has been shown to slow down tumor cell growth and motility signals, which affects movement. This drug has been used in other research studies and information from those studies suggests that ARQ 197 may help to treat your cancer. The purpose of this research study is to find out what effects ARQ 197 has on you and your cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
  • Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments. It has also been studied in phase I trials, where the appropriate dosing has been determined. Ganetespib is considered an "HSP90 inhibitor". By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment. Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so, it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the results of phase III clinical trials. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not known whether this is true in humans. In this research study, we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive, metastatic breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Ruxolitinib in Patients With Breast Cancer
  • This research study is a Phase II clinical trial. Phase II trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved ruxolitinib for your type of cancer. Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
  • A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx) expression profile in tumor samples.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Cabozantinib for Metastatic Triple Negative BrCa
  • This research study is Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved XL184 for use in patients, including people with your type of cancer. XL184 is a drug that may stop cancer cells from growing. It is a small molecule kinase inhibitor that inhibitors met and VEGFR2, as well as other targets. This drug has been used in Phase I studies in humans and laboratory experiments, and information from those other research studies suggests that this drug may help to slow tumor progression in this research study. This drug has also been used in a phase II study for breast cancer patients (a randomized discontinuation trial) suggesting good benefit for this group of patients. In this research study, we are looking at the anti-tumor effects of XL184 in metastatic breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • BKM120 For Triple Negative Breast Cancer
  • This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved BKM120 for use in patients, including people with your type of cancer. BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Phase II Study of GTx024 in Women With Metastatic Breast Cancer
  • The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • A Study of Oral Rucaparib in Patients With gBRCA Mutation Breast or Ovarian Cancer, or Other Solid Tumor
  • The purpose of the first part of the study is to evaluate the safety of different doses of oral rucaparib given daily to patients with solid tumors. The purpose of the second part of the study is to determine the safety and clinical activity of oral rucaparib given daily to patients with locally advanced or metastatic breast cancer associated with a germline breast cancer (gBRCA) mutation and to patients with platinum-sensitive relapsed ovarian cancer associated with a gBRCA mutation who have received at least two, but no more than three, prior regimens (all platinum based).
  • Diagnoses: Solid Tumor/Phase I, Breast: Metastatic
  • Status: Recruiting
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  • Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
  • This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
  • This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index
  • Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
  • This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects will have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects entering the LPT112515 study on first-line treatment will have no known history of central nervous system (CNS) metastases; subjects entering the study on second-line treatment will have no known history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The primary objective of this study is to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives include overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It is estimated that 280 subjects (140 per group) will be required to observe 193 PFS events.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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  • Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
  • The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not recommended. A signed informed consent form After signing consent there can be up to 28days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Patient will have a complete physical exam, electrocardiogram, blood tests, urinalysis, patient quality of life questionnaires and vital signs. The treatment period will be divided into 21-day (3-week) cycles. Subject will be checked for side effects for safety assessment on weekly basis for the first 6 weeks (Day 1, Day 8, Day 15, etc [+/- 3 days]) and then every 3 weeks thereafter (ie, Day 1 of subsequent cycles [+/- 3 days]).Capecitabine (1,000 mg/m2) is to be administered twice a day (every 12 hours) orally from Day 1 to Day 14 of each 21-day (3 weeks) cycle. Sorafenib or matching placebo (1 tablet in the morning followed by 2 tablets in the evening approximately 12 hours apart) is to be administered daily orally from Day 1 to Day 21 of each 21 day (3 weeks) cycle. Subjects will be followed for overall survival.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
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Showing 1-30 of 34 items
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