Breast: Metastatic Clinical Trials

Showing 1-30 of 40 items
1.
  • Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
  • This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
2.
3.
  • MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
  • This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
4.
5.
6.
  • 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
7.
  • A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
  • Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients will receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or tamoxifen (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical menopause. Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks. Therapy will be continued until PD or unacceptable toxicity. Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
8.
9.
10.
11.
  • 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
12.
  • Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer
  • This research study is testing the safety and feasibility of delivering the 4 cycles of 'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte Colony-stimulating Factor (G-CSF) support. The research study is for participants who have early stage breast cancer and have been recommended to receive a standard chemotherapy regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a "dose-dense" fashion to prevent recurrences.
  • Diagnoses: Breast: Metastatic, Breast: Early Stage Disease
  • Status: Recruiting
13.
  • 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
14.
  • Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
  • In this study, the investigators are testing the effectiveness of the combination of eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in treating advanced HER2-positive breast cancer that had received at least one prior treatment previously. At this point, the standard treatment for HER2-positive cancer that has progressed (grown) after a first treatment is chemotherapy combined with therapies that target the HER2 protein (e.g., trastuzumab or lapatinib). All of the medications that are being tested in this study are approved by the Food and Drug administration (FDA) for the treatment of metastatic breast cancer. However, the combination of these three medications in participants has not yet been tested. Eribulin is a chemotherapy agent that is approved for the treatment of metastatic breast cancer for women who have previously received at least two prior chemotherapeutic regimens for the treatment of their metastatic disease. Pertuzumab and trastuzumab are also both approved for the treatment of advanced HER2-positive breast cancer. Both agents help treat breast cancer by binding HER2 receptor. However, pertuzumab and trastuzumab bind to different parts of the HER2 receptor. The goal of this research study is to find out if adding pertuzumab, trastuzumab and eribulin is effective in treating women with metastatic, HER2-positive breast cancer. The Investigators, will also gather more information on the side effects of these treatments The investigators also plan to gather genetic information from participants' tumors (collected at biopsies). Cancers occur when the molecules that control normal cell growth (genes and proteins) are altered. Changes in the tumor genes and in the genes of normal cells are called "alterations." Many of these alterations can be detected by directly examining cancer cells in a tumor or circulating in blood. Several alterations that occur repeatedly in certain types of cancers have already been identified. These discoveries have led to the development of new drugs that "target" those alterations. More remain to be discovered. Some of the alterations are found in genes. Genes are composed of DNA "letters," which contain the instructions that tell the cells in our bodies how to grow and work. Genes make proteins which actually carry out the instructions in our cells. The investigator would like to use your DNA to look for alterations in the genes in cancer cells and blood cells using a technology called "sequencing." Gene sequencing is a way of reading the DNA to identify errors in genes that may contribute to the behavior of cells. Some changes in genes occur only in cancer cells. Others occur in normal cells as well, in the genes that may have been passed from parent to child. This research study will examine both kinds of genes. One of the scientific goals of this research study is to perform gene sequencing (gene tests) on your cancer cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of the gene tests will be used to try to develop better ways to treat and prevent cancers. As part of this work, we may also learn things about the genes in your normal cells. However, because interpretation of these tests will require further study,the investigator will not disclose these results to participants who participate on this component of the study.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
15.
16.
  • Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
  • The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent cancer growth. The single agent portion of this study is now closed to accrual. This research study is now examining the efficacy of cabozantinib in combination with fulvestrant for treatment of hormone-receptor-positive breast cancer that has spread to bone.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
17.
18.
  • 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
19.
20.
21.
  • Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
  • The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant. The Phase II portion of the study will be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
22.
  • Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
  • This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with enzalutamide may be a better treatment for patients with breast cancer.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
23.
  • BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
  • This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
24.
25.
  • A Safety Study of SGN-LIV1A in Breast Cancer Patients
  • This study is being conducted to examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer, and to find the highest dose of the drug that can be given without unacceptable side effects. Other goals of the trial are to find out if SGN-LIV1A has any antitumor effects, to learn about the pharmacokinetics of SGN-LIV1A, and to explore the relationship between antigen expression and SGN-LIV1A effects. This study will examine the safety profile of SGN-LIV1A administered as a single agent and in combination with trastuzumab for patients with HER2-positive disease.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
26.
  • Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib
  • Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. This study looks at a new approach to identifying kinases, which may help target therapy more precisely. LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of oligometastatic disease). Patients will initiate dosing with either a single HER2-directed agent or a combination of two HER2-directed agents, one week prior to surgery. Forty patients will be randomized to one of four study groups: A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose trastuzumab plus single dose pertuzumab; or D) combination single dose trastuzumab plus lapatinib daily for 7 days. Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures. The initiation of study drug will be defined by the surgical schedule; there will be no delays in standard treatment for the purposes of this study.
  • Diagnoses: Breast: Early Stage Disease, Breast: Metastatic
  • Status: Recruiting
27.
  • Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
  • This research study is a pilot study, which tests the ability of an investigational compound to be used in humans for further studies. "Investigational" means that 89Zr-bevacizumab for PET/CT imaging is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved 89Zr-bevacizumab for PET/CT imaging for use in patients, including people with your type of cancer. 89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance. The amount of the compound or drug in a radiotracer is also very small. Radiotracers are used to make images of processes that are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr). 89Zr-bevacizumab is used for an imaging procedure called positron emission tomography/computed tomography (PET/CT). This radiotracer has been used in other research studies. Information from those other research studies suggests that 89Zr-bevacizumab-PET/CT imaging may be able to measure new blood vessel formation to determine where the cancer is in your body and if your cancer is being killed by chemotherapy.
  • Diagnoses: Breast: Early Stage Disease, Breast: Metastatic
  • Status: Recruiting
28.
  • Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy
  • This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
29.
  • Novel Social Media Intervention For Older Br CA Patients
  • The number of patients 60 and older with breast cancer is increasing as our population ages. Despite the fact that the majority of breast cancers occur in patients 60 and over, these patients are consistently under-represented in clinical trials. Because patients 60 and older are an under-studied group, investigators do not have detailed information on the side effects and experiences for these patients receiving chemotherapy. Understanding the side effects patients receiving chemotherapy experience is an important part of this study. In addition, past research has shown that having poor social support can affect quality of life, mood, and outcomes for people with cancer. However, few studies in the past have focused on improving the quality of life and support systems that patients have while they receive treatment. This research study is evaluating how engaging in an online support community may improve the experience of older patients receiving chemotherapy.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
30.
Showing 1-30 of 40 items
  • Email
  • Print
  • Share
  • Text
Highlight Glossary Terms