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Inflammatory Breast Cancer
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Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)

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All Trials

Eribulin Following an Incomplete Response to Neoadjuvant Chemo

Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy (NCT01401959)

Summary

If breast cancer cells remain in the breast or lymph nodes after preoperative (neoadjuvant) chemotherapy, the risk of recurrence may be higher. Eribulin (Halaven™) is a new chemotherapy drug that has been approved for the treatment of metastatic breast cancer that has not responded well to other chemotherapy drugs. The goal of this trial is to see if eribulin may also be an effective treatment for early-stage breast cancer that has not fully responded to standard neoadjuvant chemotherapy. In patients with HER2-positive breast cancer, eribulin will be combined with Trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors.
This is a Phase II trial

Valproic Acid With FEC100 Before Surgery for Locally Advanced Breast Cancer

A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer (NCT01010854)

Summary

The chemotherapy regimen FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) is one option for treating locally advanced or primary metastatic breast cancer. Valproic Acid is approved by the US Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. The results of a Phase I study of Valproic Acid and FEC 100 suggested that this combination may be better than FEC 100 alone. Furthermore, adding Valporic Acid to FEC 100 did not appear to cause more side effects. The goal of this study is to see whether adding the drug Valproic Acid (VPA) to FEC 100 increases its effectiveness.
This is a Phase II trial

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® 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™ (Eribulin) & 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 (Halaven™) and cyclophosphamide (Cytoxan®) 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

Chemotherapy With Microwave Thermotherapy Before Surgery

Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in... (NCT01204801)

Summary

Large tumors are sometimes treated with chemotherapy prior to surgery (neoadjuvant treatment) in order to reduce the tumor's size. If the tumor does shrink, the surgeon may be able to perform a lumpectomy instead of a mastectomy. Studies have shown that cancer cells are sensitive to microwave-generated heat, and that using microwave-generated heat therapy prior to surgery can help shrink tumor size. The purpose of this study is to determine whether neoadjuvant treatment that combines focused microwave heat treatment and chemotherapy is more effective than neoadjuvant chemotherapy alone for shrinking large breast tumors.
This is a Phase III 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 Triple Negative Tumors

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

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

Eribulin & Carboplatin for Advanced Breast Cancer

A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer (NCT01795586)

Summary

Giving two cancer drugs at the same time may be more effective than using one drug alone. Eribulin (Halaven®) and carboplatin (Paraplatin®) are chemotherapy drugs that are routinely used to treat breast cancer. It is not yet known if these drugs are more effective when given together. This study is investigating the safety and effectiveness of using eribulin and carboplatin to treat people with advanced breast cancer.
This is a Phase I 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

Methotrexate and Liposomal Cytarabine For Brain Metastases

A Phase II Study of the Combination of High-dose Methotrexate and Intrathecal Liposomal Cytarabine in Patients With Parenchymal and Leptomeningeal Metastases From Breast Cancer (NCT00992602)

Summary

Brain metastases are difficult to treat because most systemic cancer treatments are unable to cross the blood-brain barrier (BBB) and get to the cancer cells in the brain. High-dose intravenous methotrexate (HD IV MTX) penetrates the blood-brain barrier and is approved by the FDA to treat breast cancer that has spread to the brain. Liposomal cytarabine also crosses the BBB. It is approved by the Food and Drug Administration (FDA) to treat lymphoma that has spread to the meninges, and is being studied in the treatment of other cancers. Giving high-dose systemic methotrexate together with liposomal cytarabine may be more effective than either drug alone. This trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with central nervous system metastases from breast cancer.
This is a Phase II trial

Low-Dose Chemotherapy with Aspirin After Neoadjuvant Therapy

Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy (NCT01612247)

Summary

There is growing evidence that aspirin may have anti-cancer properties. This may be because aspirin reduces inflammation by blocking the activity of the cylcooxygenase-2 (COX-2) protein, which has been shown to play a role in cancer metastases. Neoadjuvant chemotherapy is given before surgery to shrink tumor size. In this study, patients with stage II-III breast cancer whose tumors can still be seen at the time of surgery after neoadjuvant chemotherapy will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiation to study the safety and effectiveness of this drug combination.

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

Heated Chemotherapy for Cancer that Has Spread to the Chest

Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies (NCT01163552)

Summary

It is not uncommon for breast cancer to spread to the lining of the chest. When this occurs, surgery is usually not performed. Instead, treatment typically involves chemotherapy and/or radiation therapy. The goal of this trial is to see if treatment that involves surgically removing the tumor from the chest wall and bathing the chest cavity with a heated chemotherapy solution may be more effective than the treatments that would typically be used.
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 have had up to one prior type of chemotherapy to treat her advanced breast cancer.
This is a Phase II trial

Camptosar® for Brain Metastases That Progressed After Radiation Therapy

A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases (NCT01939483)

Summary

Researchers are studying new ways to treat brain metastases. Camptosar® (irinotecan hydrochloride) is used to treat metastatic breast cancer. It works by blocking the action of an enzyme called topoisomerase I, which helps damaged DNA survive. Studies suggest it may also be an effective treatment for brain metastases. This study is investigating the safety and effectiveness of using Camptosar to treat breast cancer patients with brain metastases who progressed after radiation therapy.

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

A Chemo Treatment Specifically for Breast Cancer That Has Spread to the Liver

Pilot Study of Hepatic Arterial Infusion (HAI) With Oxaliplatin, Folinic Acid and 5 Fluorouracil (FOLFOX) in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Breast Cancer (NCT01937507)

Summary

Hepatic arterial infusion (HAI) is a procedure that delivers chemotherapy directly to the liver. It is used to treat colorectal cancer patients with liver metastases. FOLFOX is a chemotherapy regimen frequently used for this type of treatment. FOLFOX is made up of: (FOL) Leucovorin Calcium/Folinic Acid; (F) 5 Fluorouracil/5FU; and (OX) Oxaliplatin/ Eloxatin. This study is investigating whether FOLFOX is effective for treating breast cancer that has spread to the liver in patients who have already had one type of chemotherapy since being diagnosed with metastatic disease. If the FOLFOX is effective it may shrink the cancer in the liver enough to allow surgery to be performed or it may make the liver metastases respond to other types of chemotherapy.
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.

Two Neoadjuvant Treatments for HER2-Negative Tumors

A Randomized Phase II Study of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer (NCT01527487)

Summary

Neoadjuvant therapy—treatment given prior to surgery—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 chemotherapy combinations of eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) can each be used in the neoadjuvant setting. This trial is evaluating the toxicity profiles of these two different chemotherapy combinations when they are given to patients with locally advanced HER2-negative tumors. The researchers also are investigating whether the regimens are able to eliminate the tumor (this is known as a pathological complete response).
This is a Phase II trial

Comparing Chemotherapy Treatments After Surgery

Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer (NCT00131963)

Summary

Chemotherapy drugs work in different ways to stop the growth of tumor cells. Some chemotherapy drugs kill the cancer cells; others stop the cells from dividing. For this reason, a combining chemotherapy drugs may be more effective than using one drug alone. This trial is comparing the safety and effectiveness of the combination of doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) with the combination of doxorubicin, cyclophosphamide, and paclitaxel (Taxol®) in women with nonmetastatic breast cancer. To be eligible, women must be enrolled in clinical trial CALGB-40101 or meet the eligibility criteria.
This is a Phase II trial

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

Eribulin or Paclitaxel Plus Standard Chemo Before Surgery

A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2 (NCT01593020)

Summary

Researchers are trying to determine the most effective treatment for early-stage breast cancer. Giving chemotherapy before surgery, called neoadjuvant treatment, allows the researchers to study how the tumor is responding to the chemotherapy regimen. Eribulin (Halaven®) is currently used to treat metastatic breast cancer that has already been treated with two other types of chemotherapy. Studies suggest it may also be effective when used to treat early-stage breast cancer. Paclitaxel (Taxol®) is routinely used to treat early-stage breast cancer. This trial is comparing how tumors respond to a standard chemotherapy regimen when it is given before surgery along with Halaven or Taxol. The chemotherapy regimen will be selected by the patient's oncologist. It will be either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC). Both regimens are routinely used to treat early-stage breast cancer.
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

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

Aggressive Local Therapy for Bone Metastases

Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients (NCT00929214)

Summary

Women with metastatic breast cancer that has spread to the bones are currently treated with chemotherapy or hormone therapy. Both chemotherapy and hormone therapy are systemic treatments that travel through the bloodstream to go after cancer cells that may be anywhere in the body. It is possible that using local therapy -- surgery and/or radiation -- along with systemic therapy may help control breast cancer cells that have spread to the bone. The goal of this study is to find out if adding local therapy (surgery and/or radiation) to standard systemic therapy (chemotherapy or hormone therapy) in the treatment of women with breast cancer that has metastasized to the bone can help to control the disease for a longer period of time than standard therapy alone. Participants must have no more than three areas of bone metastases.
This is a Phase II 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.

A New Patient-Controlled Tissue Expander for Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction (NCT01425268)

Summary

As part of an implant reconstruction procedure, temporary tissue expanders are placed under the skin and muscle following the mastectomy. These expanders are used to stretch out the tissue and make room for the permanent breast implant. The expander is typically inflated over time, a process that requires the patient to go to the clinic to have a saline solution injected into the expander. The AirXpanders Tissue Expander System is a new patient-controlled breast tissue expander. It has a small handheld wireless controller that administers small amounts of CO2 into the device to stretch the skin. The goal of this trial is to compare the AirXpander Tissue Expander System to the traditional saline tissue expander. To be eligible, women must be planning to have breast reconstruction that requires tissue expansion.
This is a Phase II trial

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

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

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.

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.

"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

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