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Chemotherapy

Chemotherapy for breast cancer is used to kill cancer cells in the breast or in other parts of the body. Neoadjuvant chemotherapy for breast cancer is given prior to surgery. Adjuvant chemotherapy is given after surgery.

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 III, 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 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 participants 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 participants 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

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

Evaluating if Halaven Reaches the Brain for Patients with Brain Metastases

An Intracerebral Microdialysis Study to Determine the Neuropharmacokinetics of Eribulin in Patients With Brain Metastases From Breast, Bladder, or Non-small Cell Lung Cancer (NCT02338037)

Summary

Brain metastases are difficult to treat because most cancer drugs are unable to cross the blood-brain barrier. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat patients with metastatic breast cancer that is not responding to other chemotherapy drugs. Previous studies suggest Halaven may be able to cross the blood-brain barrier. In this study, small samples of brain fluids will be collected to help determine how well Halaven gets through the blood-brain barrier in patients with breast cancer that has spread to the brain. (This trial also is enrolling patients with other types of cancers.)

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

TAS-114 and Xeloda for Advanced Breast Cancer

A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors (NCT02025803)

Summary

Researchers are developing new types of cancer treatments. TAS-114 is an experimental cytotoxic drug called a dUTPase and DPD dual inhibitor. Laboratory studies have shown that TAS-114 can cause DNA damage in cancer cells. Capeticabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. This study will determine the best dose and safety of TAS-114 when it is given with Xeloda to treat individuals with advanced breast cancer that has stopped responding to approved breast cancer treatments. This trial also is enrolling individuals with other types of solid tumors.
This is a Phase I 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

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 individuals with metastatic breast cancer 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 participants 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

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, participants 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

Oral Azacitidine + Faslodex for Metastatic ER+, HER2- Tumors in Postmenopausal Women

A Phase 2, Randomized, Open-Label, Two-arm Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women With ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (NCT02374099)

Summary

CC-486 is an oral form of Azacitidine (Vidaza®), a chemotherapy drug used to treat certain types of bone marrow cancers and other blood disorders. Laboratory studies suggest CC-486 may also be an effective breast cancer treatment. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women whose tumors have progressed on other types of hormone therapy. This study is comparing the safety and effectiveness of CC-486 and Faslodex to Faslodex alone in postmenopausal women with metastatic ER+, HER2- breast cancer that has progressed on an aromatase inhibitor.
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.

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (NCT02445391)

Summary

Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. This study will investigate whether giving one of these chemotherapy drugs after surgery reduces the risk of recurrence in patients with basal-like triple negative breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Participants will have their tumor specimens tested for basal-like qualities.
This is a Phase III 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

Fasting Along with Treatment Given Before Surgery for Newly Diagnosed Breast Cancer

A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study) (NCT02379585)

Summary

Laboratory studies suggest that fasting (not eating for a short term) can help protect normal cells from the harmful side effects of chemotherapy. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study the effect that the treatment has on the cancer cells. Researchers think that having patients fast before and after receiving neoadjuvant therapy may help reduce side effects. This study is looking at the safety and the effect that having patients fast before and after they receive neoadjuvant therapy has on the tumor. HER-2 negative patients will receive the breast cancer chemotherapy regimen (doxorubicin/Adriamycin® and cyclophosphamide/Cytoxan® followed by paclitaxel/Taxol®). HER2+ patients will receive the breast cancer regimen chemotherapy (docetaxel//Taxotere®) along with the HER2- targeted therapies (trastuzumab/Herceptin® and pertuzumab/Perjeta®) followed by pegfilgrastim/Neulasta® and docetaxel/Taxotere®.
This is a Phase I-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

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 individuals with HER2-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

Ixempra® and Stereotactic Body Radiation for Triple Negative Metastatic Tumors

A Phase II Trial Of Ixabepilone and Stereotactic Body Radiation Therapy (SBRT) For Patients With Triple Negative Metastatic Breast Cancer (NCT01818999)

Summary

Researchers are studying new drug treatments for metastatic breast cancer. Ixabepilone (Ixempra®) is used to treat metastatic or locally advanced breast cancer. Stereotactic body radiation therapy (SBRT), often referred to by brand names like CyberKnife®, delivers a high dose of radiation to the tumor more accurately than standard radiation treatment. Using Ixempra along with SBRT is not an approved treatment at this time. This study is investigating the effectiveness of using SBRT along with Ixempra in women with triple negative metastatic breast cancer.
This is a Phase II trial

Taxol & Radiation for a Chest Wall Recurrence in Patients Who Have Had Radiation Therapy

A Phase I Study of Twice Weekly Paclitaxel and Radical Re-irradiation Using Helical Tomotherapy for Aggressive Chest Wall Recurrences of Breast Cancer (NCT02058667)

Summary

Researchers are trying to determine which breast cancer patients who had radiation and whose cancer later reoccurs on the chest wall can benefit from additional radiation therapy. Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. Radiation therapy is used to treat early-stage cancer and sites of cancer metastases. This study is looking at the effectiveness of giving Taxol along with radiation to breast cancer patients who have previously been treated with radiation and have a recurrence on the chest wall.
This is a Phase I trial

Cisplatin & Radiation After Surgery for Triple Negative BC

A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer (NCT01674842)

Summary

New treatments for triple negative breast cancer are needed. Researchers believe that giving chemotherapy at the same time as radiation therapy to treat breast cancer may be more effective than using these treatments sequentially (one after another). Other types of cancers are currently treated this way. Cisplatin is a chemotherapy drug that works by preventing cancer cells from dividing and growing. It is not routinely used to treat breast cancer, but some studies suggest it may be particularly effective against triple negative tumors. Radiation is used to kill cancer cells that may have not been removed during surgery. The goal of this trial is to assess the safety, tolerability, and maximum tolerated dose of cisplatin when given at the same time as radiation to patients with triple negative breast cancer who have had or are planning to have a lumpectomy (breast conserving surgery).
This is a Phase I trial

Halaven® and Afinitor® For Metastatic Triple Negative Breast Cancer

Phase I/IB Trial of Eribulin and Everolimus in Patients With Triple Negative Metastatic Breast Cancer (NCT02120469)

Summary

Researchers are looking for new drugs to treat triple negative (ER-, PR- and HER2-) breast cancer. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer in patients who have already been treated with other chemotherapy drugs. Everolimus (Afinitor®) is used along with an anti-estrogen drug to treat advanced ER+, HER2- breast cancer. Researchers think it may also be effective in patients who are ER- and HER2-negative.This study is evaluating the safety and best dose of Halaven and Afinitor for treating patients with metastatic triple negative breast cancer.
This is a Phase I trial

Perjeta, Herceptin & Abraxane for HER2+ Metastatic Breast Cancer

Phase II Prospective Open Label Single Arm Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Metastatic Breast Cancer (NCT01730833)

Summary

Combining HER2-targeted therapies with chemotherapy may be beneficial when treating HER2+ metastatic breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are both HER2 targeted therapies.The chemotherapy drug nab-paclitaxel (Abraxane®) is routinely used to treat advanced breast cancer. This study is evaluating the effectiveness of combining Perjeta, Herceptin, and Abraxne to treat HER2+ metastatic breast cancer.
This is a Phase II trial

Everolimus & Cisplatin after Neoadjuvant Chemo & Surgery for Triple-Negative Tumors

NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY (NCT01931163)

Summary

Researchers are looking at the effectiveness of combining chemotherapy drugs with targeted therapies. Cisplatin (Platinol®) is a chemotherapy drug routinely used to treat breast cancer. Everolimus (Afinitor®) is a targeted therapy used to treat advanced hormone receptor-positive, HER2-negative breast cancer. This study is looking at the safety and effectiveness of using Platinol and Afinitor to treat patients with triple negative tumors who had chemotherapy before surgery (neoadjuvant treatment) that did not fully shrink the tumor.
This is a Phase II trial

BMN-673 With Carboplatin and Paclitaxel in Advanced BRCA+, TNBC and Other Solid Tumors

Phase I Study to Evaluate the Tolerability, Safety and Efficacy of BMN-673 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumor Malignancies That Have BRCA Mutations or Triple Negative Metastatic Breast Cancer (NCT02358200)

Summary

BMN 673 (talazoparib) is a new type of targeted therapy called a PARP inhibitor. PARP inhibitors work by preventing the PARP protein from repairing damaged DNA in tumor cells. Previous studies have suggested that PARP inhibitors are effective in breast cancer patients who have a BRCA mutation and/or a triple negative (ER-, PR-, HER2-) tumor. Researchers are studying the effectiveness of combining PARP inhibitors with different chemotherapy drugs. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are two chemotherapy drugs that are routinely used to treat breast cancer. Both work by causing damage to a cancer cell's DNA. This study is evaluating the safety, efficacy and best dose of BMN 673 when it is given with Paraplatin to individuals with breast cancer who have a BRCA mutation or a triple-negative tumor. Some participants in the study may also receive Taxol. To be eligible, a participant must have no available standard therapies.
This is a Phase I trial

The Immunotherapy Opdivo & Abraxane for Recurrent HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer (NCT02309177)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. nab-Paclitaxel (Abraxane®) is a chemotherapy drug approved in the treatment of breast cancer that has spread after treatment with combination chemotherapy or that has come back within 6 months after chemotherapy treatment post-surgery. Nivolumab (Opdivo®) is an immunotherapy approved in the treatment of certain types of metastatic melanoma and non-small cell lung cancer. Nivolumab (Opdivo®) blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 prevents a known pathway found in certain tumors and may allow the body’s own immune cells to attack tumors. This study is primarily evaluating the safety of combining Opdivo with two different regimens of Abraxane in patients with HER2-negative, recurrent metastatic breast cancer. Anti-tumor activity of Opdivo in combination with these two Abraxane regimens will be preliminarily assessed. (This study also is enrolling patients with pancreatic and non-small cell lung cancer).
This is a Phase I trial

Kadcyla, Tykerb & Abraxane vs. Herceptin, Tykerb & Taxol Before Surgery for HER2+ Tumors

Randomized Open Label Phase II Trial Of Neoadjuvant Trastuzumab Emtansine (Te) In Combination With Lapatinib (L) Follow by Abraxane (A) Compared With Trastuzumab Plus Lapatinib Follow by Paclitaxel In Her 2 Neu Over-Expressed Breast Cancer Patients (TEAL Trial) (NCT02073487)

Summary

Researchers are trying to identify the most effective drug combination for treating HER2+ breast cancer. T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors. This allows the chemotherapy drug to be delivered directly to the cancer cells. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. Giving chemotherapy before surgery allows researchers to study the effect that a treatment has on the breast tumor. This study is comparing the efficacy of Kadcyla, Tykerb and Abraxane to Herceptin, Tykerb and Taxol when it is given before surgery to patients with HER2+ breast cancer.
This is a Phase II trial

Chemotherapy and a PARP-inhibitor for BRCA1/2+, HER2- Advanced Breast Cancer

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer (NCT02163694)

Summary

Researchers are studying new types of breast cancer drugs and drug combinations. Veliparib is a new type of cancer therapy called a PARP inhibitor. By blocking the PARP enzyme, veliparib keeps cancer cells from repairing DNA damage. Studies suggest that combining veliparib with chemotherapy drugs that damage DNA may make the cancer cells more responsive to the chemotherapy treatment. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs used to treat advanced breast cancer. This study is comparing the effectiveness of veliparib, paraplatin, and Taxol with paraplatin and Taxol alone in treating participants with a BRCA1 or BRCA2 mutation who have advanced HER2-negative breast cancer.
This is a Phase III trial

MM-398 for Triple Negative Breast Cancer

A Pilot Study in Patients Treated With MM-398 to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages (NCT01770353)

Summary

Researchers are studying new drugs for treating metastatic triple negative breast cancer. MM-398, a new type of targeted therapy, uses a fat molecule (like a bubble) to deliver the chemotherapy drug irinotecan (Camptosar®) to cancer cells. Because the irinotecan is delivered directly to the cancer cell, it can be given at a higher dose. Ferumoxytol (Feraheme) is used during an MRI to improve imaging. It is being used in this study to measure a type of white blood cell called tumor associated macrophages. The goal of this study is to learn more about how MM-398 travels in the body and whether using ferumoxytol is effective in tracking MM-398.
This is a Phase I trial

EC1456 For Triple Negative Breast Cancer

A PHASE 1 STUDY OF FOLIC ACID-TUBULYSIN CONJUGATE EC1456 IN PATIENTS WITH ADVANCED SOLID TUMORS (NCT01999738)

Summary

EC1456 is a new type of injectable drug that consists of folate (vitamin B9) linked to a chemotherapy drug called tubulysin B hydrazide (TubBH). The folate receptor is highly expressed in triple negative breast cancer. This suggests that EC1456 might be effective in triple negative breast cancer because the folate would deliver the chemotherapy drug to the cancer cell. This study is evaluating the effect of EC1456 in participants with triple negative breast cancer. This study is also enrolling individuals with other types of advanced solid tumors.
This is a Phase I trial

Chemotherapy and a Targeted Therapy Before Surgery for Stage III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT02436993)

Summary

Stage II and III tumors are typically treated with chemotherapy before surgery. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. In this study patients with HER2-negative tumors will receive chemotherapy and Avastin and patients with HER2-positive tumors will receive chemotherapy along with Herceptin and Perjeta. Researchers will evaluate the safety and efficacy of the two treatment protocols. They will also investigate whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how the tumor will respond to the treatment.
This is a Phase II trial

Veliparib & Doxil for Triple Negative Metastatic Breast Cancer

PHASE I STUDY OF ABT-888, PARP INHIBITOR, AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN RECURRENT GYNECOLOGIC CANCER AND BREAST CANCER (NCT01145430)

Summary

Researchers are developing new treatments for triple negative breast cancers. Veliparib is a poly(ADP-ribose) polymerase (PARP) inhibitor. It blocks an enzyme that plays an important role in cell growth, which can cause cancer cells to die. Studies suggest velaprib can slow or stop the growth of triple negative breast cancer cells. Liposomal doxorubicin hydrochloride (Doxil®) is a chemotherapy drug used to treat breast and other types of cancers. Giving veliparib with Doxil may be more effective than giving veliparib alone. This trial is studying the side effects and the best dose of veliparib when it is given with Doxil to patients with triple negative metastatic breast cancer. (This study is also enrolling women with ovarian, fallopian and peritoneal cancers.)
This is a Phase I trial

Capecitabine + BKM120 in Triple Negatvie Breast Cancer With Brain Metastases

Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Triple Negative Breast Cancer (TNBC) Patients With Brain Metastases (NCT02000882)

Summary

BKM120 is an investigational targeted therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow. Capecitabine (Xeloda®) is a chemotherapy drug used to treat triple negative (ER-, PR-, HER2-) breast cancer. Early studies suggest that combining Xeloda with BKM120 may be an effective way to treat triple-negative breast cancer. These studies have also suggested that this treatment may be able to cross the blood-brain barrier, to kill cancer cells. This study is evaluating the safety and effectiveness of BKM120 and Xeloda in patients with triple-negative breast cancer that has spread to the brain.
This is a Phase II trial

Veliparib, Carboplatin & Chemo Before Surgery in Stage II-III Triple Negative Tumors

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC) (NCT02032277)

Summary

Researchers are trying to develop the best treatments for triple negative breast cancer. Veliparib (ABT-88) blocks PARP, an enzyme that plays an important role in controlling cancer cell growth. Studies suggest it is effective in triple negative breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug that studies suggest is effective for triple negative breast cancer. TAC (Taxotere®, Adriamycin®/doxorubicin and cyclophosphamide®) is a chemotherapy regimen routinely used to treat breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that a drug combination has on breast cancer cells. This study is comparing the safety and effectiveness of three different treatment combinations–veliparib, Paraplatin and TAC; Paraplatin and TAC; and TAC—when they are given before surgery to patients with stage II or stage III triple negative breast cancer.
This is a Phase III trial

Panitumumab and Chemotherapy for Inflammatory Breast Cancer

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression (NCT01036087)

Summary

Inflammatory breast cancer (IBC) is an aggressive type of advanced breast cancer. It is typically treated with chemotherapy prior to surgery. Panitumumab (Vectibix®) is a targeted therapy that works by preventing or slowing the growth of tumor cells by blocking proteins, called epidermal growth factor receptors, that are on the surface of cancer cells. Panitumumab is currently approved for the treatment of certain types of colorectal cancer, and researchers think it might also be effective for IBC. The goal of this trial is to study the safety and effectiveness of panitumumab when it is given with the chemotherapy drugs nab-paclitaxel (Abraxane®), carboplatin (Paraplatin®), fluorouracil (Adrucil®), epirubicin (Ellence®), and cyclophosphamide (Cytoxan®) before surgery to treat HER2-negative IBC.
This is a Phase II trial

GDC-0941 and Platinol For Triple Negative Metastatic Breast Cancer

A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer (NCT01918306)

Summary

Researchers are looking for new ways to treat triple negative breast cancer. GDC-0941 is a new type of cancer therapy called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor growth. Cisplatin (Platinol®) is a chemotherapy drug that is used to treat triple negative breast cancer. Laboratory studies suggest that giving a PI3K inhibitor such as GDC-0941 along with cisplatin may be an effective way to treat AR-negative, triple negative breast cancer. The first phase of this study will determine the maximum tolerated dose of GDC-0941 to use along with Platinol and the side effects associated with that dose. The second phase of the study will examine the safety and effectiveness of using GDC-0941 and Platinol for patients with triple negative breast cancer who also have low androgen receptor activity. All patients who are interested in this trial will have their tumor tested to for its androgen receptor (AR) status.
This is a Phase I-II trial

Pazopanib, Paclitaxel & Carboplatin for Advanced Breast Cancer

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors (NCT01407562)

Summary

Pazopanib (Votrient®) is a targeted therapy that works by inhibiting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit—proteins that help tumors grow and survive. Pazopanib has been approved for the treatment of kidney cancer, and researchers are currently investigating whether it may be effective in certain other cancers as well. Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are two chemotherapy drugs routinely used to treat advanced breast cancer. The goal of this study is to determine the safety, tolerability, and maximum tolerated dose of pazopanib when it is combined with weekly paclitaxel and carboplatin in patients with advanced breast cancer.
This is a Phase I trial

Perjeta, Herceptin and Chemo Before Surgery for HER2-Positive Breast Cancer

Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer (NCT01855828)

Summary

Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. T-FEC is a chemotherapy regimen used to treat breast cancer. "T" refers to paclitaxel (Taxol®), which is given first and then followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide). Herceptin is often given with T-FEC. This study is investigating the effectiveness of adding Perjeta to Herceptin and T-FEC by giving it before surgery to women with stage I - III HER2+ breast cancer.
This is a Phase II trial

Kadcyla + Perjeta vs Herceptin + Perjeta + Chemo Before Surgery in HER2+ Breast Cancer

A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER (NCT02131064)

Summary

Giving therapy before surgery (neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Kadcyla® (trastuzumab emtansine) is used to treat HER2+ metastatic breast cancer. It combines the chemotherapy drug DMI with trastuzumab (Herceptin®). Perjeta® (pertuzumab) and Herceptin® are targeted therapies used to treat HER2+ breast cancer. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are chemotherapy drugs used to treat HER2+ breast cancer. This study is comparing the effect of Kadcyla and Perjeta to the effect of Herceptin, Perjeta, Taxotere and Paraplatin on cancer cells when it is given before surgery to women with HER2+ breast cancer.
This is a Phase III trial

MM-302 Plus Herceptin For Previously Treated HER2-Positive Advanced Breast Cancer

A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer (NCT02213744)

Summary

Researchers are trying to develop less toxic ways to use effective chemotherapy drugs. MM-302 is a targeted therapy that delivers the chemotherapy drug doxorubicin directly to HER2+ cells. By delivering doxorubicin directly to the cancer cells, researchers believe the drug will cause fewer side effects and less damage to the heart. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This trial is comparing the safety and effectiveness of MM-302 and Herceptin to chemotherapy and Herceptin in patients with HER2+ advanced breast cancer who were previously treated with Herceptin, who have either progressed on or cannot take pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®) and have not been previously treated with doxorubicin or other anthracyclines.
This is a Phase II-III trial

Tykerb, Afinitor & Xeloda for HER2+ Brain Metastases

Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab (NCT01783756)

Summary

Breast cancer that has metastasized (spread) to the brain is difficult to treat because most cancer drugs are unable to cross the blood-brain barrier. Lapatinib (Tykerb®) is currently used along with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer. Everolimus (Afinitor®) is currently used along with exemestane (Aromasin®) to treat advanced hormone-sensitive breast cancer. Both Tykerb and Afinitor are able to cross the blood-brain barrier. Researchers believe that using Tykerb, Xeloda, and Afinitor at the same time may be an effective way to treat HER2+ brain metastases. This study will evaluate the safety and effect that the combination of Tykerb, Xeloda, and Afinitor have on women whose tumors are HER2+, have brain metastases, and have already been treated with trastuzumab (Hercepin®).
This is a Phase I-II trial

BAY1217389 and Taxol for Advanced Breast Cancer

An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies (NCT02366949)

Summary

BAY1217389 is a new type of cancer drug called an MPS1 inhibitor. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat advanced breast cancer. Laboratory studies suggest that giving BAY1217389 with Taxol may improve Taxol's effectiveness and keep cancer cells responding to Taxol longer. This study will determine the best dose, safety, and tolerability of BAY1217389 when it is given with Taxol to individuals with advanced breast cancer. (This trial is also enrolling individuals with other types of advanced cancer for the first part of the trial and patients with triple negative breast cancer for the second part of the trial.) To be eligible, participants must have no standard therapy available.
This is a Phase I trial

Targeted Therapies Plus Chemo Before Surgery For ER+, HER2+ Breast Cancer

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study) (NCT02345772)

Summary

Giving therapy before surgery -- called neoadjuvant treatment -- allows doctors to study how well a tumor responds to a cancer regimen. If the therapy is successful, there are no cancer cells remaining at the time of surgery--and the patient is said to have had a "pathologic complete response." Some studies have suggested that women who have a pathologic complete response after neoadjuvant treatment have a better prognosis. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies. This study will look at the effectiveness of using Faslodex, Taxotere, Herceptin and Perjeta to obtain a pathologic complete response in women with ER+, HER2+ breast cancer.

Ruxolitinib And Taxol in Advanced Triple Negative, Inflammatory Breast Cancer

Phase II Study of Combination Ruxolitinib (INCB018242) With Preoperative Chemotherapy for Triple Negative Inflammatory Breast Cancer Following Completion of a Phase I Combination Study in Recurrent/Metastatic Breast Cancer (NCT02041429)

Summary

Ruxolitinib was approved by the FDA in 2011 to treat a type of bone marrow cancer. Laboratory studies have shown that the drug blocks a pathway (called IL6/JAK/Stat), which may stop cancer cells from growing. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer patients. Laboratory experiments suggest that giving ruxolitinib along with Taxol may make the Taxol more effective. This study is investigating the safety and effectiveness of giving ruxolitinib and Taxol to women with advanced or metastatic triple-negative, inflammatory breast cancer for which there are no other standard treatments available. It is the first study to test this drug combination in breast cancer.
This is a Phase I-II trial

Chemotherapy, Herceptin, Plus Tykerb for HER2-Positive Metastatic Cancer

Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Ttrastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen (NCT01873833)

Summary

Researchers are looking for new combination of drugs to treat HER2+ metastatic breast cancer. Cyclophosphamide (Cytoxan®) is a chemotherapy drug that stops the growth of tumor cells. Lapatinib (Tykerb®) is a targeted therapy commonly used with Capacitabine (Xeloda®) to treat HER2+ metastatic breast cancer. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. Combining these drugs may be a more effective regimen for treating HER2+ metastatic breast cancer.
This is a Phase II trial

Halaven, Herceptin and Perjeta for Advanced HER2-Positive Breast Cancer

A Phase II Study of Eribulin Mesylate in Combination With Trastuzumab and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer (NCT01912963)

Summary

Researchers are trying to identify the most effective drug combinations for treating advanced HER2+ breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are targeted therapies used to treat HER2-positive tumors. These three drugs have not yet been tested as a combination therapy. This study is looking at the safety and effectiveness of using Halaven, Herceptin and Perjeta to treat advanced HER2-positive breast cancer.
This is a Phase II trial

Istodax and Abraxane For Metastatic Inflammatory Breast Cancer

A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer (NCT01938833)

Summary

Researchers are studying new treatments for inflammatory breast cancer (IBC). Romidepsin (Istodax®) is a histone deacetylase (HDAC) inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that help cancer cells grow. Laboratory studies suggest that Istodax, which is used to treat lymphoma, may be an effective treatment for IBC. Protein-bound paclitaxel (Abraxane®) is a chemotherapy drug used to treat IBC. Giving Istodax wtih Abraxane may be more effective than giving Abraxane alone. This study is designed to determine the side effects and best dose of Istodax to use with Abraxane to treat individuals with metastatic IBC.
This is a Phase I-II trial

Ipatasertib and Taxol Before Surgery for Early-Stage Triple-Negative Breast Cancer

A PHASE II RANDOMIZED, DOUBLE-BLIND, STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR TO AKT, IN COMBINATION WITH PACLITAXEL AS NEOADJUVANT TREATMENT FOR PATIENTS WITH EARLY STAGE TRIPLE NEGATIVE BREAST CANCER (NCT02301988)

Summary

Scientists are trying to develop new drugs that will be effective for patients with triple-negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Ipatasertib (GDC-0068) is a new type of targeted cancer therapy called an AKt inhibitor. It blocks a pathway inside the cell that regulates the cell's growth and survival. Early studies suggest that ipatasertib may be effective in patients with triple-negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. This study is comparing the effectiveness of Taxol and ipatasertib to Taxol and a placebo when it is given before surgery to patients with early-stage triple-negative breast cancer.
This is a Phase II trial

Chemotherapy, Herceptin, Perjeta & an AI Before Surgery for ER+, HER2+ Stage I-III Tumors

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation (NCT02003209)

Summary

Researchers are trying to determine the best treatment for ER+, HER2+ tumors. Docetaxel (Taxotere®) and carboplatin (Paraplatin®) are two types of chemotherapy drugs used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. This four drug combination is called TCHP. Aromatase inhibitors (AIs) are used to treat ER+ tumors in postmenopausal women. Premenopausal women can use an AI if they also take Goserelin (Zoladex®), a drug that stops ovarian function. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study the effect that a treatment has on cancer cells. This study is comparing the effect of giving TCHP with an AI to giving TCHP alone before surgery to women with stage I-III breast cancer. Following treatment, all of the women will have a lumpectomy or mastectomy followed by whole breast radiation and one year of Herceptin.
This is a Phase III trial

Targeted Therapy with Chemotherapy Before Surgery in Stage II-III Breast Cancer

Next Generation Sequencing to Evaluate Breast Cancer Subtypes and Genomic Predictors of Response to Therapy in the Preoperative Setting for Stage II-III Breast Cancer (NCT01959490)

Summary

Researchers are trying to determine ways to predict which types of tumors will respond best to which drug combinations. Giving chemotherapy and targeted therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect a drug combination has on the cancer cells. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2+ breast cancer. Bevacizumab (Avastin®) is a drug that keeps tumors from developing the blood vessels they need to survive. In this trial, patients with stage II-III HER2+ tumors will receive Herceptin and chemotherapy before surgery and patients with stage II-III HER2- tumors will receive Avastin and chemotherapy before surgery.
This is a Phase II trial

RO5509554 Alone or With Taxol for Advanced Breast Cancer (And Other Solid Tumors)

Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors. (NCT01494688)

Summary

RO5509554 is an new type of cancer drug that blocks the colony-stimulating factor 1 receptor, a protein that is believed to play a role in cancer growth. Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. This study is looking at the safety and effectiveness of giving RO5509554 alone or RO5509554 with Taxol to patients with advanced breast cancer (and other types of solid tumors).
This is a Phase I trial

Abraxane + an Anti-Inflammatory for Advanced Breast Cancer

Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Weekly Nab Paclitaxel Plus Anakinra in Metastatic Breast Cancer Patients (NCT01802970)

Summary

Studies have suggested that inflammation may play a role in cancer growth. This has led researchers to believe that drugs that work by decreasing inflammation may be useful in treating cancer. Anakinra (Kineret®) is used to treat rheumatoid arthritis. It is a "biologic" medicine. This means that it is closely related to a protein that occurs naturally in the body. Nab paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. The objective of this study is to determine the safety of giving Kineret along with Abraxane to treat advanced breast cancer.
This is a Phase I trial

BYL719 and Abraxane for Advanced HER2-Negative Breast Cancer

Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer (NCT02379247)

Summary

Researchers are looking for new ways to treat advanced HER2-negative breast cancer. BYL719 is a new type of drug called a PI3K inhibitor. It slows or stops cancer cells growth by blocking the activity of the PI3K protein. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study will determine the best dose, safety, and effectiveness of BYL719 when it is given with Abraxane to treat women with advanced HER2-negative breast cancer.
This is a Phase I-II trial

Gemzar, Herceptin & Perjeta for Previously Treated Advanced HER2+ Breast Cancer

Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer (NCT02139358)

Summary

Researchers are trying to determine the best combination of drugs to use to treat advanced HER2-positive breast cancer. Gemcitabine (Gemzar®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy drugs. Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are two different types of HER2-targeted therapies. This study is looking at effectiveness of and side effects associated with using Gemzar, Herceptin and Perjeta to treat advanced HER2+ breast cancer in patients who have already been treated with one other chemotherapy drug and a HER-targeted therapy.
This is a Phase I-II trial

Taxotere & A New Immune Therapy in Metastatic Breast Cancer

A Phase II Double-Blinded, Randomized, Placebo-Controlled Study of Docetaxel in Combination With 1-methyl-D-tryptophan (Indoximod) in Metastatic Breast Cancer (NCT01792050)

Summary

Researchers are studying news types of drugs and new drug combinations that could be used to treat metastatic breast cancer. Docetaxel (Taxotere®) is routinely used to treat breast cancer. Indoximod is a new type of drug called an IDO pathway inhibitor. It works by blocking an enzyme called IDO that plays a role in the immune system. Laboratory studies suggest that giving IDO along with Taxotere can make the Taxotere more effective. The purpose of this study is to see whether combining Taxotere and Indoximod is more effective than using Taxotere alone to treat metastatic breast cancer.
This is a Phase II trial

A Vaccine & Chemotherapy Followed by Anakinra or Booster Shots for Triple Negative Tumors

Pilot Safety Trial of Anakinra Combined With Chemotherapy and Dendritic Cell Vaccine in Patients With Locally Advanced, Triple-Negative Breast Cancer (NCT02018458)

Summary

Immunotherapy–teaching the body's immune system to go after cancer cells—is a new area of cancer research. A dendritic cell vaccine is a patient-specific vaccine that is manufactured by taking a blood sample from the patient. After receiving the vaccine, patients typically receive a series of booster shots. Anakinra (kineret) stops inflammation by blocking IL-1 β, an immune protein found in high levels in breast cancer. It is currently used to treat rheumatoid arthritis and other autoimmune diseases. Studies suggest it may help bolster cancer vaccines. ACT (Adriamycin®, Cytoxan®, Taxol®) is a chemotherapy regimen commonly used to treat breast cancer. This study is comparing the effectiveness of using vaccine booster shots or Anakinra following treatment with ACT and the dendritic cell vaccine in patients with locally advanced triple negative breast cancer.
This is a Phase I-II trial

Immunotherapy and Abraxane for Advanced Triple Negative Breast Cancer

A Study of MPDL3280A in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer (NCT02425891)

Summary

Researchers are investigating the effectiveness of immunotherapies in patients with triple negative (ER-, PR- and HER2-) breast cancer. MPDL3280a (atezolizumab) is an investigational immunotherapy that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death (PD-1) that normally keeps the body's immune system from attacking and destroying tumor cells. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study is comparing the safety and effectiveness of Abraxane and atezolizumab to Abraxane and a placebo in patients with previously untreated locally advanced or metastatic triple negative breast cancer.
This is a Phase III trial

ADI-PEG 20 and Adriamycin for HER2-Negative Metastatic Breast Cancer

Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor (NCT01948843)

Summary

Some cancers, including breast cancer, require the amino acid arginine. ADI (Arginine deiminase) is an enzyme that breaks down arginine. ADI-PEG20 is a formulation of ADI that is currently in phase I and phase II studies in a small number of cancer types, including breast cancer. Doxorubicin (Adriamycin®) is a chemotherapy drug routinely used to treat breast cancer. This study will determine the safety and efficacy of giving ADI-PEG20 with Adriamycin to patients with HER2-negative metastatic breast cancer. All interested women will have a metastatic site biopsied to determine the tumor's ASS (Argininosuccinate synthetase) levels. Only whose tumors have ASS deficiency will be eligible for this study.
This is a Phase I 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

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

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.

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

Mifepristone and Halaven For Advanced Triple Negative Breast Cancer

Phase I Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast Cancer With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer (NCT02014337)

Summary

Researchers are trying to determine the best drug combination for treating advanced triple negative breast cancer. Laboratory studies suggest that cortisol, a glucocorticoid stress hormone, and its receptors play a part in the process that leads tumors to stop responding to chemotherapy. Mifepristone is a steroid that blocks the glucocorticoid receptor (GR). Blocking this receptor may make chemotherapy more effective. Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer. This is a two-part study. Part one will determine the best dose of mifepristone to use with Halaven in participants with advanced triple negative breast cancer. Part two will look at the effectiveness of the best dose of mifepristone with Halaven in participants with advanced triple negative breast cancer whose tumors test GR+.
This is a Phase I trial

Whole Body Hyperthermia And Chemotherapy For Metastatic Disease

Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer (NCT00003135)

Summary

Scientists are trying to find new ways to treat metastatic disease. Whole body hyperthermia (WBH) is a cancer therapy that involves heating the body to a temperature of up to 104 degrees. Studies have shown that WBH is able to kill cancer cells by heating them to several degrees above body temperature. Heat also has been shown to make chemotherapy treatments more effective. During WBH, conscious sedation is used to keep the patient comfortable and responsive. This trial is designed to evaluate the effectiveness of using WBH in combination with chemotherapy for treating metastatic disease, and to determine the optimal amount of time to maintain the elevated heat.
This is a Phase II trial