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All Trials

The Effect of Xeloda and Digoxin on Metastatic Breast Tumors

Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment (NCT01887288)

Summary

Capecitabine (Xeloda®) is used to treat metastatic breast cancer. One way to give Xeloda is at low doses at regular intervals. This is called metronomic dosing. Digoxin is a drug that is currently used to treat heart failure and abnormal heart rhythms. Laboratory studies have shown that digoxin blocks a protein, called HIF-1, that can slow the growth of breast cancer cells. This study is investigating the effect that combining metronomic dosing of Xeloda with digoxin has on the growth rate of metastatic breast cancer cells. To be eligible, participants must have already been treated with anthracyclines and taxanes.
This is a Phase II trial

Chemotherapy Before Surgery for Stage 3, HER2-Negative Disease

Phase II Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer (NCT01498588)

Summary

Previous studies have shown that giving chemotherapy before surgery, called neoadjuvant treatment, is as effective as giving it after surgery. However, receiving chemotherapy first may shrink the tumor, allowing the patient to have less extensive surgery. It also allows researchers to study how the tumor responds to chemotherapy. The purpose of this study is to evaluate the effectiveness of a new chemotherapy regimen that combines eribulin (Halaven®), which is currently approved for use in treating metastatic breast cancer, followed by the neoadjuvant standard of care -- doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®). To be eligible, participants must have locally advanced (stage III) HER2-negative disease.
This is a Phase II trial

Taxol/Abraxane & Radiation at the Same Time for Locally Advanced Breast Cancer

Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation (NCT02280252)

Summary

The term locally advanced breast cancer commonly includes tumors whose maximum diameter is 5 cm (T3) or larger, or that have spread to the chest wall or skin. Researchers are trying to determine the best way to treat these patients. Paclitaxel (Taxol®, Abraxane®) is a chemotherapy drug routinely used to treat breast cancer. This study is investigating the effectiveness of giving Taxol or Abraxane and radiation at the same time to treat locally advanced breast cancer. To be eligible, a woman must have locally-advanced breast cancer (stage IIB, IIIA, or IIIB). Metastatic patients are limited to those with an intact breast, a locally advanced tumor, and involved ipsilateral supraclavicular node.
This is a Phase II trial

Taxol® and Cytoxan® after Surgery for Stage I and II Disease

A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients (NCT01106898)

Summary

Researchers are investigating whether there may be more effective ways of combining the chemotherapy treatments currently being used in the adjuvant (after surgery) setting. The chemotherapy drugs cyclophosphamide (Cytoxan®) and paclitaxel (Taxol®), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab (Herceptin®) with this chemotherapy regimen to individuals with HER2+ tumors may be an effective treatment. The goal of this study is to determine the effectiveness of the combination of the standard chemotherapy drugs cyclophosphamide and paclitaxel (and Herceptin for those with HER2+ tumors) after surgery for Stage I or II breast cancer.
This is a Phase II trial

Halaven & Cytoxan for Advanced Breast Cancer

A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies (NCT01554371)

Summary

Combining two or more cancer drugs that work in different ways may be more effective than using one cancer drug at a time. Eribulin (Halaven®) is approved for treating metastatic breast cancer. Cyclophosphamide (Cytoxan®) is approved for treating many different types of cancer, including breast cancer. However, the combination of eribulin and cyclophosphamide is considered experimental. The purpose of this study is to test the safety and effectiveness of the two drugs when they are given together at different doses to patients with locally advanced or metastatic breast cancer (and other solid tumors).
This is a Phase I-II trial

Treating Node-Positive Tumors with Low Oncotype DX® Scores

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive Breast Cancer (NCT01272037)

Summary

Women with hormone-sensitive, HER2-negative breast cancer who have 1-3 positive lymph nodes are typically treated with chemotherapy. Oncotype DX® is a genetic test that is done on a small piece of tumor tissue. It is used to assess the likelihood that a patient with a hormone-sensitive, node-negative tumor will have a breast cancer recurrence. Women with a high recurrence score are treated with chemotherapy and hormone therapy. Women with a low recurrence score are treated with hormone therapy alone. Previous studies have suggested that the Oncotype DX® test can also accurately assess recurrence risk in certain node-positive patients. The goal of this trial is to determine whether women with 1-3 positive nodes and a low Oncotype DX® score require chemotherapy and hormone therapy or if they can be treated with hormone therapy alone. To be eligible, participants must have an Oncotype DX® score of 25 or less.
This is a Phase III trial

Vidaza and Abraxane For Advanced Breast Cancer

A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer (NCT00748553)

Summary

Azacitidine (Vidaza®) is a chemotherapy drug that is used to treat certain types of bone marrow cancers and blood cell disorders. Laboratory studies suggest it may also be an effective breast cancer treatment. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This trial is investigating the safety of Vidaza when it is used along with Abraxane to treat patients with advanced breast cancer. The phase I part of the study is designed to determine the best dose of Vidaza to use along with Abraxane in patients with metastatic cancer who have already had at least one other anti-cancer drug. The phase II part of the trial will use the best dose (which was determined in phase I) to study the safety and effectiveness of the drug combination as a first-line treatment in patients with advanced or metastatic HER2-negative breast cancer. (This trial is also enrolling patients with other types of solid tumors.)
This is a Phase I-II trial

Taxotere and Paraplatin Before Surgery in ER-, HER2- Stage II-III Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery (NCT02124902)

Summary

Researchers are trying to determine the best treatments for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. This study is looking at the effect that Taxotere and Paraplatin have on cancer cells when they are given before surgery to treat patients with stage II or stage III triple-negative breast cancer.
This is a Phase II trial

Intraductal Carboplatin Before Surgery for DCIS

A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (NCT00669747)

Summary

It is possible that putting chemotherapy directly into the breast duct can stop the growth of DCIS. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat ovarian cancer. It is believed to slow or stop cancer growth by attaching directly to the cancer cell's DNA. The goal of this study is to determine the safety and effectiveness of carboplatin when it is put inside the breast ducts (intraductally) of patients with DCIS who are scheduled to have surgery. The researchers are also studying the effects carboplatin has on DCIS and breast tissue biomarkers.
This is a Phase II trial

Neoadjuvant Metronomic Chemotherapy for Stage II-III Triple Negative Breast Cancer

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer (NCT00542191)

Summary

Metronomic chemotherapy is new approach to treatment that involves giving very low doses of chemotherapy over a longer period of time. There is evidence that metronomic chemotherapy can slow tumor blood vessel growth and produce fewer side effects than standard high-dose chemotherapy. Research has also shown it to be effective in tumors that have not responded to standard treatment. Given the limited options available for women with hormone-negative and HER2-negative breast cancer, researchers are studying the effectiveness of metronomic chemotherapy before surgery in women with triple-negative disease.
This is a Phase II trial

TPI 287 for Brain Metastases

A Phase II Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain (NCT01332630)

Summary

Brain metastases are difficult to treat because most systemic cancer treatments are unable to cross the blood-brain barrier to get to the cancer cells in the brain. The experimental drug TPI 287 is a new type of taxane. Like other taxanes, TPI 287 works by preventing cancer cells from dividing. However, unlike other taxanes, TPI 287 has been shown to cross the blood-brain barrier. The purpose of this trial is to determine the effectiveness of TPI 287 in controlling brain metastases that have progressed with prior therapy.
This is a Phase II trial

Cisplatin vs. AC Before Surgery in Patients w/ a BRCA Mutation

A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations (NCT01670500)

Summary

Women and men who are born with a BRCA1 or BRCA2 genetic mutation are at increased risk of developing breast cancer. Cisplatin is a platinum-containing chemotherapy drug that is used alone or in combination with other drugs to treat ovarian, bladder, and testicular cancers; it is sometimes used to treat other types of cancer as well. It is not FDA approved to treat breast cancer. Doxorubicin (Adriamycin®) and cyclophosphamide--known as AC--is routinely used to treat breast cancer. Giving chemotherapy in the neoadjuvant (before surgery) setting allows researchers to study how the tumor responds to the treatment regimen. It can also shrink the tumor, potentially allowing a patient to have a lumpectomy instead of a mastectomy. This study is comparing cisplatin to AC in BRCA+ women and men with newly diagnosed breast cancer.
This is a Phase II trial

FdCyd + THU For Advanced Breast Cancer

A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU) (NCT00978250)

Summary

Over time, advanced breast cancer can stop responding to a standard treatment. Scientists think that a combination of two experimental drugs, FdCyd (5-fluoro-2'-deoxcytidine), and THU (tetrahydrouridine), may be effective in treating this type of tumor. FdCyd is thought to work by changing what certain genes do in cancer cells. THU does not have any anticancer effects, but it can help keep the other drug, FdCyd, from being broken down by the body. The purpose of this trial is to determine the safety, tolerability, and effectiveness of the combination of FdCyd and THU in men and women with advanced breast cancer that has progressed on at least one standard therapy.
This is a Phase II trial

Carboplatin, Gemzar®, and Mifepristone For Advanced Breast Cancer

Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer (NCT02046421)

Summary

Researchers are looking for new ways to block cancer cell growth. Cortisol, a glucocorticoid stress hormone and its receptors play a part in the process that gets cancer cells to stop responding to chemotherapy. Mifepristone is a steroid that blocks the glucocorticoid receptor (GR). It also blocks progesterone. Carboplatin (Paraplatin®) and gemcitabine hydrochloride (Gemzar®) are chemotherapy drugs that work in different ways to slow or stop cancer cell growth. This study is will identify the best dose and side effects associated with using mifepristone and Gemzar along with Paraplatin to treat patients with advanced breast cancer. Patients may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for stage III or stage IV breast cancer. This trial also is enrolling patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
This is a Phase I trial

Combinations of Abraxane, Gemzar & Paraplain for Triple Negative Stage IV Tumors

A Phase 2/3, Multi-center, Open-label, Randomized Study of Weekly Nab-paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to the Combination of Gemcitabine and Carboplatin, as First-line Treatment in Female Subjects ... (NCT01881230)

Summary

Researchers are trying to determine the best drug combinations for treating triple negative (ER-, PR-, HER2-) breast cancer. Nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs used to treat advanced breast cancer that has not responded to previous chemotherapy. This study is comparing the safety and effectiveness of combining Abraxane with either Gemzar or Paraplatin to the combination of Gemzar and Paraplatin as a first-line treatment for triple negative metastatic breast cancer. This study has two phases. In Phase 2, Abraxane and Gemzar are being compared to Abraxane and Paraplatin. In Phase 3, one of these two combinations will be compared to Gemzar and Paraplatin.
This is a Phase II-III trial

Neoadjuvant Chemotherapy for Stage II or III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-Paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT00618657)

Summary

Individuals with Stage II or III breast cancer may not be candidates for breast conservation surgery (lumpectomy) if their tumors are too large. As an alternative to mastectomy, chemotherapy may be given prior to surgery (neoadjuvant chemotherapy) in order to shrink the tumor so it can be removed by breast conservation surgery. This trial will evaluate the benefits of giving neoajduvant chemotherapy with carboplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) in combination with trastuzumab (Herceptin®) for HER2-positive breast cancer or bevacizumab (Avastin®) for HER2-negative disease, before surgery in women with Stage II or III breast cancer.
This is a Phase II trial

Abraxane® and Paraplatin® for Stage III Triple Negative Tumors

Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer (NCT01525966)

Summary

Chemotherapy drugs work by either killing cancer cells or by stopping them from dividing. Giving chemotherapy before surgery (called neoadjuvant therapy) may make the tumor smaller and reduce the amount of tissue that needs to be removed. Researchers can also study a drug's effectiveness by assessing how much the tumor shrinks in response to the treatment. Abraxane® (nab-paclitaxel) and Paraplatin® (carboplatin) are chemotherapy drugs that are approved for the treatment of advanced breast cancers. The goal of this study is to determine how well these two chemotherapy drugs work when they are given together before surgery to treat women with locally advanced or inflammatory triple negative (ER-/PR-/HER2-) breast cancer.
This is a Phase II trial

ThermoDox & Hyperthermia to Treat Chest Wall Recurrences

A Phase I/II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Breast Cancer Recurrence at the Chest Wall (NCT00826085)

Summary

ThermoDox® is a new form of chemotherapy, in which the doxorubicin (Adriamycin®) is encased within a fat bubble (liposome) and released in the presence of heat. Applying external heat to a tumor (hyperthermia) is known to kill tumor cells directly, but may also make them more sensitive to ThermoDox®. Research has suggested that ThermoDox® plus hyperthermia therapy may be more effective than chemotherapy alone for treating locally recurrent breast cancer in the chest wall. The main purpose of this study is to find out if adding ThermoDox® to therapeutic heat will increase how long the breast cancer stays away after treatment.
This is a Phase I-II trial

Capecitabine & Paclitaxel Before Surgery in Stage II-III Cancer

Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer (NCT00397761)

Summary

Chemotherapy drugs work in different ways to stop the growth of tumor cells. Giving two drugs (combination chemotherapy) that work in different ways before surgery may shrink the tumor and reduce the amount of normal tissue that needs to be removed. Capecitabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. Upon reaching a cancer cell, the drug is converted by the body into the chemotherapy drug 5-fluorouracil (5FU). Paclitaxel (albumin-stablized nanoparticle formulation) (Abraxane®) works in a different way than 5FU to stop tumor cells from growing. It is routinely used to treat early-stage and advanced breast cancer. The goal of this trial is to evaluate the safety and effectiveness of using the combination of capecitabine and paclitaxel as neoadjuvant treatment in women with stage II-III breast cancer.
This is a Phase II-III trial

Halaven in Previously Treated Metastatic Breast Cancer

Phase II Trial of Metronomic Eribulin (Halaven) In Pretreated Metastatic Breast Cancer (MBC) (NCT01908101)

Summary

Eribulin mesylate (Halaven®) is approved to treat metastatic breast cancer patients who have had at least two other types of anti-cancer medicines since learning their tumor had spread to other parts of their body. This study is investigating the effectiveness of Halaven in women with metastatic breast cancer who have received at least one prior anti-cancer drug.
This is a Phase II trial

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer (NCT01221870)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. Paclitaxel (Taxol®) is a taxane that is administered intravenously. It is one of the most commonly used breast cancer therapies. Tesetaxel is a taxane that is administered orally. Studies suggest it is as effective as Taxol, and because it is an oral drug, it is easier to give to patients, does not cause infusion reactions, and is less likely to result in neuropathy. This trial is investigating the safety and effectiveness of tesetaxel when it is given as first-line therapy to patients with metastatic breast cancer.
This is a Phase II trial

Doxil® and Heat Treatment for Advanced Breast Cancer

Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer (NCT00006433)

Summary

Researchers are studying ways of delivering chemotherapy drugs that may make the treatment more effective. Pegylated liposomal doxorubicin (Doxil®) is a newer form of doxorubicin (Adriamycin®) that is made by coating the drug with a small amount of lipid (fat). Studies have shown that this coating helps get more drug to the tumor without causing as many side effects. Researchers believe that combining heat treatment with Doxil® may further increase the amount of drug that gets to the tumor, which may increase tumor response. This trial is evaluating the safety and effectiveness of the combination of Doxil® and heat treatment in women with advanced breast cancer. The researchers will also look at whether the heat treatment changes how much of the drug gets into the tumor. To be eligible, participants must have locally advanced breast cancer located on the chest wall following mastectomy or have metastatic disease with advanced tumor remaining within the breast.
This is a Phase II trial

Docetaxel & Cytoxan Before Surgery For High Recurrence Scores

Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25 (NCT00832338)

Summary

Receiving chemotherapy before surgery, referred to as neoadjuvant therapy, may shrink the size of a breast tumor, permitting less extensive surgery. It can also help determine if a cancer is responsive to a specific chemotherapy regimen. The purpose of this study is to assess the effectiveness of neoadjuvant chemotherapy with docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®). To be eligible for this study, you must have an Oncotype DX® score of 25 or greater. Oncotype DX® is a test that is done on tumor tissue to assess a woman's risk of a breast cancer recurrence. Studies have found that women with hormone receptor-positive breast cancers with Oncotype DX® scores greater than or equal to 25 obtain a significant benefit from chemotherapy given after surgery.
This is a Phase II trial

Eribulin for Advanced HER2-Negative Breast Cancer

A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes (NCT01827787)

Summary

The chemotherapy drug eribulin (Halaven®) received FDA approval in 2010 for the treatment of metastatic breast cancer patients who had already received at least two prior chemotherapy regimens. Researchers are now studying the effectiveness and side effects associated with using Halaven as the first or second chemotherapy drug given to treat advanced or metastatic breast cancer. One of the side effects the researchers will be studying is neuropathy, a numbness or tingling of the fingers and toes that can be caused by chemotherapy. To be eligible for this study, a woman must have a HER2-negative tumor and may have had up to one prior type of chemotherapy to treat her advanced breast cancer.
This is a Phase II trial

Abraxane in Patients Age 65 and Over with Metastatic Disease

Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer (NCT01463072)

Summary

Cancer patients who are 65 and over may experience more treatment-related side effects than younger patients do. Paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) is a drug used to treat breast cancer that has spread or that has come back within 6 months after chemotherapy. The researchers also hope to identify ways to predict which patients may be more likely to experience side-effects and/or benefit from an altered dosage schedule.
This is a Phase II trial

Tesetaxel vs Capecitabine for Advanced Disease

A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer (NCT01609127)

Summary

Taxane drugs, such as paclitaxel (Taxol®) and docetaxel (Taxotere®), are commonly used to treat breast cancer. They work by blocking the ability of cancer cells to divide. Tesetaxel (DJ-927) is an investigational taxane that is given orally. (The other taxanes are given intravenously.) Capecitabine (Xeloda®), is a type of drug called an antimetabolite. It is approved for the treatment of advanced breast cancer. This trial is comparing the effectiveness and safety of two different tesetaxel regimens in combination with Xeloda. To be eligible, patients must have HER2-negative advanced breast cancer.
This is a Phase II trial

Treatment and Tissue Collection Before Surgery in Patients With Stage II-III Breast Cancer

Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy (NCT01897441)

Summary

Giving treatment before surgery—called neoadjuvant therapy—allows researchers to study the effect that the cancer drugs have on the breast tumor. Collecting and storing samples of tissue from breast cancer patients for laboratory research may help scientists learn which tumors respond best to certain treatments. This trial is collecting and storing tissue from patients with stage II-III breast cancer who have been given one of three different treatment combinations prior to surgery.

An Oral Fluorouracil (5-FU) for Metastatic Breast Cancer

A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer (NCT01231802)

Summary

Fluorouracil (5-FU) is a chemotherapy drug that is used to treat breast and other cancers. It is given by IV. To increase its effectiveness, 5-FU (Adrucil®) is usually given in combination with leucovorin, a type of folic acid (Vitamin B-9). Eniluracil is an experimental drug that is an oral version of 5-FU. Eniluracil lasts longer in the body than 5-FU, allowing it to be given at a lower dose. Capecitabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. When it reaches a cancer cell, Xeloda is converted by the body into 5-FU. The purpose of this trial is to determine if eniluracil plus 5-FU/leucovorin is more effective and has fewer side effects than Xeloda when it is given to women with metastatic breast cancer who have been previously treated with an anthracycline and a taxane.
This is a Phase II trial

Propranolol & Chemo Before Surgery for Stage I-II Breast Cancer

A Phase II Study of the Beta-blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer (NCT01847001)

Summary

Propranolol (inderal®) is an FDA-approved drug used to treat high blood pressure, heart failure, angina, anxiety, and migraine. Laboratory studies suggest that Inderal also blocks the growth of the blood vessels cancer cells need to survive. Giving chemotherapy before surgery (neoadjuvant therapy) allows researchers to study how cancer cells respond to a treatment. This study is exploring the effectiveness of and side effects associated with giving Inderal along with neoadjuvant chemotherapy to treat stage I or II breast cancer. To be eligible, a woman must be receiving AC (adriamycin and cyclophosphamide) or paclitaxel (Taxol®) with or without Trastuzumab (Herceptin®) chemotherapy before surgery.
This is a Phase II trial

Cisplatin vs. Paclitaxel Before Surgery for Triple Negative Breast Cancer

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer Without Germline BRCA Mutations: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker (NCT01982448)

Summary

Researchers are trying to determine the best drugs for treating triple negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that cancer drugs have on tumor cells. Cisplatin (Platinol®) is a chemotherapy drug used to treat other types of cancers that laboratory studies suggest may be effective against triple negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer. The HRD (Homologous Recombination Deficiency) assay is a tumor test that researchers think can predict if the tumor will respond to a specific type of chemotherapy. This study is comparing the effect that Platinol and and Taxol have on triple negative breast tumors when it is given before surgery. The study is also looking at whether the HRD assay can predict if the tumor will respond to the treatment.
This is a Phase II trial

Targeted Chemotherapy for Brain Metastases

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (NCT01480583)

Summary

Metastases to the brain is difficult to treat because the vast majority of drugs are not able to cross the blood-brain barrier. GRN1005 is an investigational chemotherapy drug that was designed to take advantage of a natural mechanism that allows essential substances, like hormones and lipids, to enter the brain. It works by linking the standard chemotherapy drug paclitaxel (Taxol®) to a protein "key" that helps substances to cross the blood-brain barrier. The goal of this trial is to determine the safety and effectiveness of GRN1005 when it is given to individuals who have breast cancer that has spread to the brain.
This is a Phase II trial

Halaven vs. Taxol for Advanced Breast Cancer

A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer (NCT02037529)

Summary

Researchers are conducting studies to determine which chemotherapy drugs should be used, and in what order, to treat advanced breast cancer. Eribulin (Halaven®) is currently used to treat metastatic breast cancer that has not responded or has stopped responding to other chemotherapy drugs. Paclitaxel (Taxol®) is one of the most commonly used breast cancer therapies. This study is comparing the effectiveness of Halaven and Taxol when they are used as the first or second treatment in women with HER-negative advanced breast cancer.
This is a Phase III trial

DM-CHOC-PEN For Brain Metastases

A Phase II Trial: Safety and Tolerance of Intravenous 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Malignancies Involving the Central Nervous System (NCT02038218)

Summary

DM-CHOC-PEN (4-Demethyl-4-cholesteryloxycarbonylpenclome) is an experimental chemotherapy drug. Small studies in cancer patients, including patients with breast cancer, have shown that it can kill cancer cells and that it can penetrate the blood-brain barrier. This study is evaluating the safety and efficacy of DM-CHOC-PEN in patients with breast cancer that has metastasized to the brain. This study is also enrolling patients with lung cancer and melanoma who have brain metastases.
This is a Phase II trial

Early Surgery for Newly Diagnosed Stage IV Breast Cancer

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (NCT01242800)

Summary

Approximately 3 to 4 percent of patients with newly diagnosed breast cancer have stage IV (metastatic) disease. When this occurs, the tumor is not usually removed unless it is causing symptoms such as ulceration or pain. (This is called palliative surgery.) It is not known whether removing the breast tumor before it causes problems (called early surgery) may help to extend survival. The goal of this trial is to compare early surgery with standard palliative surgery in individuals with metastatic disease who have a tumor in the breast. To be eligible, participants must have an intact primary (not recurrent) tumor in their breast.
This is a Phase III trial

Nipple-Sparing Mastectomy

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy (NCT01002014)

Summary

Many women choose to have a skin-sparing mastectomy when they have immediate breast reconstruction. During a traditional skin-sparing mastectomy, all of the breast skin is preserved, except for the nipple and areola. Nipple-sparing mastectomy is a procedure that allows women to keep their nipple and areola as well. The goal of this study is to observe the cosmetic outcomes, patient satisfaction, and complications of nipple-sparing mastectomy. To be eligible, women must be planning to have either a therapeutic or prophylactic mastectomy.

Breast-Conserving Surgery to Treat Multiple Breast Tumors

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer (NCT01556243)

Summary

Early data suggest that one reason the mastectomy rate is increasing is due to the increased identification of multiple ipsilateral breast cancers (MIBC)—more than one tumor in the same breast. This may be because of the perceived belief that women with MIBC are at greater risk of having a local recurrence. The purpose of this study is to assess the local recurrence (LR) rate that occurs after breast conserving surgery (lumpectomy) is performed in patients with MIBC. To be eligible, participants must have two or three foci of biopsy-proven breast cancer in no more than two quadrants of the breast.
This is a Phase II trial

A New Way to Assess Tumor Margins During Surgery

A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery (NCT01796041)

Summary

Studies suggest that up to 70 percent of women who choose to have a lumpectomy need a second operation (a re-excision) because the initial surgery did not result in a clean margin--an area around the tumor that is cancer-free. Currently surgeons feel the breast tissue to determine whether they have obtained a clean margin. This trial is looking at whether an imaging technique that can be performed during surgery makes it easier to identify tumor margins and decreases the need for a second operation. To be eligible, participants must be planning on having a lumpectomy.
This is a Phase O trial

Cryoablation (Freezing) Instead of Surgery & Radiation for Older Women with Small Tumors

Freezing Alone Instead of Resection and Radiotherapy Of Small Breast Tumors: A Study of Cryoablation in the Management of Prognostically Favorable Early Stage Breast Cancer in Elderly Women (NCT01992250)

Summary

Cryoablation uses extreme cold to destroy cancerous tumors. The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276°F) to freeze and kill the breast tumor. The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm). This study is looking at how well cryoablation works to prevent local recurrence in women 70 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer. To be eligible for this study, a woman must have a tumor that is classified as Luminal A on a core needle biopsy.

Laser Therapy as an Alternative to Surgery for Small Tumors

A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers (NCT01478438)

Summary

Novilase Interstitial Laser Therapy (ILT) is an image-guided, minimally invasive alternative to a surgical lumpectomy. It works by destroying breast cancer cells. The goal of this study is to evaluate whether minimally invasive laser ablation of early-stage breast cancer is as effective as a traditional surgical lumpectomy. To be eligible, participants must have a tumor that is 2 cm or smaller.

Regional Anesthesia and Breast Cancer Recurrence

Regional Anesthesia and Breast Cancer Recurrence (NCT00418457)

Summary

Surgery is the primary and most effective breast cancer treatment. The goal of surgery is to remove all of the cancer. However, scattered micrometastases and/or a few tumor cells are almost always missed. While a variety of factors determine whether a woman will go on to have a breast cancer recurrence, recent animal and human studies suggest that replacing general anesthesia/analgesia with regional anesthesia/analgesia results in a lower incidence of breast cancer metastases. This trial will help determine whether the risk of recurrence differs between women who receive regional anesthesia/analgesia compared to those who receive general anesthesia/analgesia.
This is a Phase III trial

Reducing Mastectomy-Related Pain

Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer (NCT00859157)

Summary

Post-operative mastectomy pain is a routine occurrence in women being treated for breast cancer. Tumescent mastectomy is a new surgical technique that involves use of a local anesthesia instead of a general anesthesia. The local anesthesia causes the breast to swell during surgery, which may reduce post-operative pain. The goal of this trial is to compare pain experienced by patients who receive a tumescent mastectomy with that of patients who receive a standard mastectomy. To be eligible, patients must be planning on having a mastectomy without immediate breast reconstruction.

Lumpectomy and Radiofrequency Ablation

ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer (NCT01153035)

Summary

During a lumpectomy, the surgeon removes the tumor as well as some tissue surrounding the tumor. After the surgery, if the pathologist finds that there were cancer cells near the edges (margin) of the removed tissue, a second operation may be needed to remove more tissue. Radiofrequency ablation is a procedure that uses heat generated by an electrical current to destroy tumor tissue. Researchers believe that radiofrequency ablation given during a lumpectomy may help to ensure that no cancer remains in the margins. This may reduce the need for a second surgery. It also may reduce the chance of a local recurrence. The purpose of this trial is to see if lumpectomy followed by radiofrequency ablation reduces the need for a second surgery. To be eligible, participants must be planning to receive a lumpectomy.

"Rational Dose" Gamma Knife Radiosurgery for Brain Metastases

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection (NCT02005614)

Summary

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of Gamma Knife® Radiosurgery is a non-surgical procedure that is recognized as the preferred treatment for brain tumors. "Rational dose" is a method that assesses the best dose of radiation by taking into account tumor volume, prior radiation, and the relative resistance of the tumor to radiation. (Some tumors, like melanomas, are considered radioresistant wheres others, like breast cancer, are considered radiosensitive.) This study is evaluating the effectiveness of and side effects associated with using the rational dose method for gamma knife radiosurgery to treat brain metastases. The information will be used to design future studies on gamma knife radiosurgery. This study is enrolling patients with brain metastases from breast cancer as well as other types of cancers.
This is a Phase II trial

Meso BioMatrix Device for Breast Reconstruction

Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial (NCT01823107)

Summary

Breast reconstruction after mastectomy is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. Surgeons have recently begun using a mesh derived from human cadaver skin to create a pocket for the tissue expander. The Meso BioMatrix Acellular Peritoneum Matrix is a new mesh that is similar to human skin and recently cleared by the FDA. This is a feasibility trial—a small study to evaluate how this mesh performs during breast reconstruction. The results of this trial, if successful, may be used to design a larger clinical trial in the future.
This is a Phase I-II trial

A Study of Two Types of Mesh That May Improve Breast Reconstruction

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial (NCT01310075)

Summary

Breast reconstruction with implants is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. During the second surgery, the expander is replaced with an implant(s). Researchers are studying new absorbable mesh products that can be used to support a breast implant as the tissue around it heals. The mesh may help reduce complications and improve appearance. AlloDerm® and SurgiMed® are two absorbable mesh products. AlloDerm is made with human cadaver skin. SurgiMed is made with calve skin. This study is comparing the appearance and rate of complication of breast reconstruction surgeries that use one of these mesh products with surgeries that do not use mesh. To be eligible, a patient must be scheduled to have a skin-sparing mastectomy with any of the surgeon co-investigators eligible for the study.

Proton Radiation Therapy for Cancer That Has Spread to the Liver

Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases (NCT01697371)

Summary

Metastatic breast cancer often spreads to the liver. Not all patients with liver metastases are able to have surgery to remove the cancer in the liver. Stereotactic body radiotherapy using proton therapy may be an effective option for these patients. Proton therapy (also called proton beam therapy) is a type of radiation treatment that uses protons to destroy cancer cells. Because it is a more precise type of radiation therapy, proton therapy may be a good option for patients with liver metastases. This trial will determine the feasibility and safety of using stereotactic body proton therapy to treat patients whose cancer has spread to the liver. This trial is enrolling patients with many different types of cancer.

Determining the Best Time for Reconstruction after Radiation

Effect of Radiation on Tissue for Delayed Breast Reconstruction (NCT01666899)

Summary

The best time to begin breast reconstruction when a patient has both a mastectomy and radiation is not yet known. The purpose of this study is to investigate the effects of radiation therapy following mastectomy by looking at samples taken from skin and blood vessels at various times after mastectomy. The investigators will look at various properties of the skin including its blood flow to determine an ideal time for breast reconstruction.To be eligible, patients must be planning to have a mastectomy, post-mastectomy radiation, and post-mastectomy breast reconstruction.

Single Dose Radiation for DCIS or Early-Stage Breast Cancer

Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer (NCT01754519)

Summary

The standard treatment for ductal carcinoma in situ (DCIS) and early-stage breast cancer is lumpectomy (breast conserving surgery) followed by breast radiation. Radiation therapy uses high-energy x-rays to kill tumor cells that may be left behind following surgery. Single fraction radiation therapy (SFRT) is a high dose of radiation that is given during surgery. This trial is studying the safety and effectiveness of using SFRT during a lumpectomy surgery to treat post-menopausal women with DCIS or early-stage breast cancer.
This is a Phase II trial

Breast CT to Guide Radiation & Surgery After Neoadjuvant Chemo

Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial (NCT01771497)

Summary

Giving chemotherapy or hormone therapy before breast cancer surgery--called neoadjuvant treatment--can shrink the breast tumor, which may allow less tissue to be removed during surgery. Breast CT scans takes 3D images of the breast that may make it easier for doctors to more accurately measure the size, volume, and density of breast tumors. This study is investigating whether using the Koning Breast CT to take images of the breast tumor during neoadjuvant treatment provides a more accurate assessment of the tumor's size and location and leads to improved surgical and radiation therapy outcomes.

Proton Radiation Therapy After Lumpectomy for Early-Stage Breast Cancer

Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors. (NCT01310530)

Summary

Proton beam therapy is a new type of radiation treatment that uses protons rather than x-rays to kill cancer cells. It is not more effective than x-ray radiation, but it does expose less healthy tissue to radiation. The standard treatment following a lumpectomy is whole breast radiation. However, studies have shown that partial breast radiation may be a viable alternative for some patients. The purpose of this trial is to determine the safety, effectiveness and side effects of partial breast radiation with proton therapy in patients with early stage breast cancer who have had a lumpectomy.
This is a Phase II trial

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