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Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast CancerDoxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer (NCT02488967)

Summary

Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC--and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Carboplatin (Paraplatin®) is a platinum-based chemotherapy drug that studies suggest is effective for triple-negative breast cancer. This study is comparing the effectiveness of AC followed by Taxol followed by Paraplatin to AC followed by Taxol in patients with triple-negative breast cancer. To be eligible, participants must have had breast cancer surgery with clean margins (cancer-free area around where tumor was removed). Patients who did not have clean margins will need to have radiation therapy to the chest wall before entering the trial.

Phase I/II Trial of Cisplatin Plus Romidepsin in Locally Recurrent or Metastatic Triple Negative Breast Cancer or BRCA1 or BRCA2 Mutation Associated Locally Recurrent or Metastatic Breast Cancer. (NCT02393794)

Summary

Romidepsin (Istodax®) is an FDA-approved drug that is currently used to treat a type of lymphoma. Laboratory studies suggest Istodax may also be effective for treating breast cancer. Cisplatin (Platinol®) is a platinum-based chemotherapy drug that studies suggest is effective for treating triple-negative breast cancer. In the first phase of the study, researchers will determine the highest dose of Istodax that can safely and tolerably be used in combination with Platinol. In phase II, this highest dose will be given along with Platinol. Both phases of the study will enroll women with advanced breast cancer who are known to carry a BRCA mutation or who have triple negative breast cancer.

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) (NCT03747120)

Summary

To take part in this study you must have HER2 positive stage I, II or III breast cancer and have not yet received any treatment for your breast cancer.

This study will compare the safety and effects (good or bad) of three different breast cancer treatment regimens that will be given before breast cancer surgery. The drugs used in different combinations in the treatment regimens are the HER2-targeted therapy trastuzumab (Herceptin®); the HER2-targeted therapy pertuzumab (Perjeta®); the immunotherapy pembrolizumab (Keytruda®); and the chemotherapy drug paclitaxel (Taxol®).

A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors (NCT03076372)

Summary

To take part in this study, you must have metastatic triple negative (ER-/PR-/HER2-) breast cancer. This study will determine the best dose, safety and effect (good and bad) of a new type of targeted drug researchers think will be effective in patients with metastatic triple negative breast cancer. The new drug is called MM-310. It delivers the chemotherapy drug docetaxel (Taxotere®) directly to cancer cells. Results from this study will help researcher determine the best dose of MM-310 to use when it is combined with other anti-cancer drugs. This study is also enrolling patients with other types of solid cancers.

BrUOG 308: Efficacy of Weekly Carboplatin and Paclitaxel With Trastuzumab and Pertuzumab (wPCbTP) and Switching to an Anthracycline-based Regimen (AC) in Non-responding Patients as Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer (NCT02789657)

Summary

To take part in this study, you must have been diagnosed with HER2-positive stage I-III breast cancer and not yet have received any treatment. This study is investigating the effectiveness of using chemotherapy and HER2-targeted drugs to kill cancer cells in the breast and lymph nodes before surgery. The chemotherapy drugs being used in this study are paclitaxel (Taxol®) and carboplatin (Paraplatin®). Both are commonly used to treat breast cancer. The HER2-targeted drugs used in this study are trastuzumab (Herceptin®) and pertuzumab (Perjeta®). If after 12 weeks of treatment your tumor has not gotten smaller, your chemotherapy combination will change to doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®). Known as AC chemotherapy, it is another commonly used breast cancer treatment.

A Multi-Centered Randomized Phase II Study Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer (NCT02531932)

Summary

Paraplatin (Carboplatin®) is a platinum-based chemotherapy drug used to treat metastatic breast cancer that has not responded to previous treatments. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow. This study will compare the safety and effectiveness of Carboplatin and Afinitor to Carboplatin alone for treating metastatic triple-negative breast cancer.

An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer (NCT03786094)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer that has been treated with chemotherapy.

This study is comparing the safety, effectiveness and side effects of using eribulin (Halaven®) alone or in combination with balixafortide. Halaven is a chemotherapy drug used to treat advanced breast cancer. Balixafortide is an investigational immunotherapy drug that targets CXCR4.

LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial) (NCT03018080)

Summary

To take part in this study, you must have HER2-negative metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using the chemotherapy drug paclitaxel (Taxol®) along with the immunotherapy pembrolizumab (Keytruda®) to treat metastatic HER2-negative breast cancer. The researchers are studying two different treatment regimens. In one regimen, patients will receive Taxol followed by Taxol and Keytruda at the same time. In the other, patients will receive Taxol and Keytruda at the same time. Taxol is routinely used to treat breast cancer. Keytruda is approved to treat certain types of cancers.

Phase Ib Study of Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Patients With Metastatic Breast Cancer(NCT02824575)

Summary

To take part in this study, you must have HER2-negative breast cancer that has spread to other parts of your body (metastatic). You must have already received chemotherapy. If your tumor is hormone-sensitive, you must have already taken an anti-estrogen drug. Rebastinib is a new drug that is available only in clinical trials. This study is looking at how well it works when it is given along with a chemotherapy drug. Rebastinib is a targeted drug. The chemotherapy drugs being used in this study are paclitaxel (Taxol®) and eribulin (Halaven®). Both are used to treat metastatic breast cancer. The researchers will look at what treatments you have already had to decide whether you should get Taxol or Halaven.

A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine (NCT02915744)

Summary

To take part in this study, you must have metastatic breast cancer that has spread to your brain. You must have undergone prior radiation and/or surgery and the brain metastasis must be considered stable. You must also have been treated with an anthracycline, a taxane, and capecitabine (Xeloda®) at some point following your first diagnosis with breast cancer. This study is comparing the safety and effectiveness of a new chemotherapy drug to a Treatment of Physician's Choice in patients with metastatic breast cancer who have stable brain metastases. The new chemotherapy drug is called NKTR-102. It is only available in clinical trials. The Treatment of Physician's Choice will be selected from the following seven standard of care chemotherapies: eribulin (Halaven®), ixabepilone (Ixempra®), vinorelbine (Navelbine®), gemcitabine (Gemzar®), paclitaxel (Taxol®), docetaxel (Taxotere®) or nab-paclitaxel (Abraxane®). All of these drugs are routinely used to treat metastatic breast cancer.

Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02593175)

Summary

To take part in this study, you must have been diagnosed with triple-negative, early-stage breast cancer but not yet had surgery. In addition, you must have a type of tumor that is not likely to get smaller if you receive the standard type of chemotherapy given before surgery. Vectibix, Paraplatin, and Taxol are three different types of cancer drugs. Researchers think that giving all three drugs at the same time before surgery will shrink triple negative tumors. Panitumumab (Vectibix®) is a targeted treatment used to treat certain types of colorectal cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that are used to treat breast cancer.

A Phase IIB Study of Neoadjuvant Enzalutamide (ZT) Regimen Therapy in Combination With Weekly Paclitaxel for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer(NCT02689427)

Summary

To take part in this study, you must have stage I-III triple negative breast cancer (ER-, PR- and HER2-). Your tumor must also be androgen receptor positive (AR+). This study is looking at the safety and effect of giving an anti-androgen drug along with chemotherapy before surgery to patients with triple negative breast cancer. This will allow the researchers to study the effect the drugs have on your breast tumor. If you are enroll in the study, your tumor will be tested to see if is AR+. You can only stay in the study if your tumor is AR+. Androgen receptors (AR) are found on many triple-negative breast tumors. Researchers think drugs that block these receptors could keep breast cancer cells from growing. The anti-androgen drug that will be used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer. It will be given with paclitaxel (Taxol®), a chemotherapy drug used to treat breast cancer.
This is a Phase II trial

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).

Single Arm Neoadjuvant Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant With Weekly Nab-paclitaxel and Dose-dense Doxorubicin/Cyclophosphamide (ddAC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer (NCT02489448)

Summary

MEDI4736 is a new immunotherapy drug. By blocking a protein called PD-1 (programmed cell death 1), it allows the immune system to go after cancer cells. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC chemotherapy--and nab-paclitaxel (Abraxane®) are routinely used to treat breast cancer. Giving MEDI4736 with this chemotherapy regimen before surgery (called neoadjuvant therapy) may make the chemotherapy more effective. This study will investigate the best dose and effectiveness of MEDI4736 for use with this chemotherapy regimen when it is given before surgery to individuals with stage I-III triple negative breast cancer.

Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Paclitaxel and Trastuzumab in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab and Taxane-Based Therapy (NCT03179904)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using a new targeted therapy along with a chemotherapy and a HER2-targeted therapy to treat HER2 positive advanced breast cancer. The new targeted therapy used in this study is TVB-2640. It stops cancer cells from growing by targeting a protein called FASN. The chemotherapy drug used in this study is paclitaxel (Taxol®). The HER2-targeted drug is trastuzumab (Herceptin®).

A Phase I Study of AZD8186 in Combination With Docetaxel in Patients With PTEN Mutated or PIK3CB Mutated Advanced Solid Tumors, Potentially Amenable to Docetaxel (NCT03218826)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer that will potentially respond to the chemotherapy drug docetaxel (Taxotere®).

This study will determine the best dose and effects (good and bad) of an experimental targeted therapy when it is used with a chemotherapy to treat tumors that test positive for PTEN or PIK3C-beta mutations. The targeted therapy is AZD8186. Taxotere is a chemotherapy commonly used to treat breast cancer. This study is also enrolling patients with other types of cancers.

A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)(NCT03838367)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that the researchers find tests positive for CCR5, have received an anthracycline and a taxane before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy), and not have been treated with chemotherapy or a checkpoint inhibitor for metastatic breast cancer.

This study is investigating the best dose, safety and effects (good and bad) of leronlimab when it is used along with carboplatin. Leronlimab is an investigational targeted therapy that blocks CCR5. Carboplatin is a chemotherapy drug used to treat breast cancer.

A Phase Ib/II Study of Olaparib With Sapacitabine in BRCA Mutant Breast Cancer (NCT03641755)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer and have been tested for and found to have an inherited BRCA mutation. If your tumor is hormone sensitive, you must have already been treated with at least one hormone therapy. If your tumor is HER2 positive you must have already tried at least two HER2-targeted therapies.

This study is looking at the safety, effects (good and bad) and best dose of sapacitabine to use along with olaparib (Lynparza®). Sapacitabine is an investigational chemotherapy drug that is given by mouth. Lynparza is a type of targeted therapy known as a PARP inhibitor. PARP inhibitors block poly (ADP-ribose) polymerase, an enzyme that plays a role in cancer cell growth. Lynparza is approved to treat HER2-negative metastatic breast cancer.

A Phase I/IB Study of Ipatasertib in Combination With Carboplatin or Carboplatin/Paclitaxel in Patients With Metastatic Triple Negative Breast Cancer (NCT03853707)

Summary

To take part in this study you must have metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to standard treatment options.

This study is investigating the best dose of ipatasertib (GDC-0068) when it is used along with paraplatin (Carboplatin®) alone or with paraplatin (Carboplatin®) and paclitaxel (Taxol®). Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells grow and divide. Carboplatin and Taxol are chemotherapy drugs used to treat breast cancer.

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02456857)

Summary

In this study, participants will receive the experimental drug regimen DAT, which consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). Doxil is a chemotherapy drug used to treat breast cancer. Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor. This study is investigating the effect that the DAT regimen has when it is given before surgery to women with triple-negative breast cancer. To be eligible, patients must have stopped a neoadjuvant anthracycline-based regimen because the cancer progressed or they experienced too many side effects to continue.

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors (NCT03601897)

Summary

To take part in this study, you must be a woman or man with metastatic breast cancer.

This study is evaluating the safety and effects (good and bad) of using the experimental drug rebastinib along with paclitaxel (Taxol®) in patients with metastatic breast cancer. Rebastinib is an investigational targeted therapy. Taxol is a chemotherapy drug used to treat breast cancer. This study is also enrolling women with ovarian cancer and endometrial cancer.

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (NCT03337724)

Summary

To take part in this study, you must have advanced HER2- (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of using a new targeted therapy along with paclitaxol (Taxol®) for treating advanced HER2- breast cancer. The targeted therapy, ipatasertib (GDC-0068), blocks a protein called AKt that helps cancer cells divide and grow. Taxol is a chemotherapy drug routinely used to treat 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 (EA1131) (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.

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer (NCT02648477)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy drug that targets the programmed cell death (PD-1) protein. Blocking this protein allows the body's immune system to attack cancer cells. Doxorubicin (Adriamycin®) is a chemotherapy drug commonly used to treat breast cancer. Aromatase inhibitors (anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®) are used to treat hormone-sensitive tumors in postmenopausal women. This study is investigating the safety and effectiveness of using Keytruda to treat HER2-negative metastatic breast cancer. In this study, patients with triple-negative tumors will receive Adriamycin along with Keytruda, while patients with hormone-sensitive tumors will receive an AI along with Keytruda.To be eligible, participants must not have been treated previously with Keytruda.

A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies (NCT02897375)

Summary

To take part in this study, you must have been diagnosed with stage III or stage IV (metastatic) breast cancer.

This study is looking at the safety and effectiveness of two different drug combinations. All patients in this study will receive palbociclib (Ibrance®) with a chemotherapy drug, either cisplatin (Platinol®) or carboplatin (Paraplatin®). Ibrance is a new type of targeted drug called a CDK inhibitor. It is approved to treat postmenopausal women with ER-positive, HER2-negative metastatic breast cancer who have not already had an anti-estrogen drug. The two chemotherapy drugs, Platinol and Paraplatin, are are used to treat advanced breast cancer that has not responded to previous chemotherapy treatments.

A Phase I Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer (NCT02599363)

Summary

Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK6, that help cancer cells grow. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Retinoblastoma (RB) is a tumor suppressor protein. Laboratory studies suggest targeting the Rb pathway by inhibiting the CDK4 and CDK6 enzymes may be an effective breast cancer treatment. This study will identify the best dose of ribociclib to use along with Taxol to treat patients with metastatic breast cancer. Interested patients will have their tumor tested for the Rb protein. Only those whose tumor tests positive for this protein will be eligible to enroll.

A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer (NCT02623972)

Summary

Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer. AC (Adriamycin® and Cytoxan®) is used to treat inflammatory breast cancer before surgery. Adding Halaven to the AC treatment may be more effective than using AC alone. This study is evaluating the safety and effectiveness of treating HER2-negative inflammatory breast cancer patients with Halaven and AC before they have surgery.

A Phase Ib Trial of LY2157299 (TGFβR1 Kinase Inhibitor) With Paclitaxel in Patients With Triple Negative Metastatic Breast Cancer (NCT02672475)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat advanced breast cancer. Galunisertib (LY2157299) is a new type of targeted therapy. It works by blocking a protein called TGF-betaR1 kinase. This study will evaluate the best dose and safety of galunisertib and Taxol for treating patients with metastatic triple-negative breast cancer that also tests androgen-receptor negative.

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma Not Amenable to Resection or Transplant (NCT00986661)

Summary

To take part in this study you must have stage IV (metastatic) breast cancer that has spread to the liver.

This study will look at the safety and effects (good and bad) of a PV-10 injection into the liver. PV-10 targets and concentrates in tumor cells. When used along with radiation, it may make radiation more effective. It also may get the immune system to go after cancer cells. This study will also include patients who have liver cancer or who have other types of cancers that have spread to the liver.

Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers (NCT02595320)

Summary

Capecitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer that has stopped responding to other chemotherapy drugs. Because it is an oral drug, it can be taken at home. This study is comparing the effectiveness and side effects associated with two different doses and dosing schedules of Xeloda in women with metastatic breast cancer. This study is also recruiting individuals with advanced/metastatic gastrointestinal cancer.

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer (NCT03012100)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effectiveness of cyclophosphamide (Cytoxan®) given with a cancer treatment vaccine to Cytoxan given alone. FR alpha peptide vaccine is a personalized vaccine that is made by removing some of your white blood cells and mixing them in a lab with tumor proteins. The vaccine is a type of immunotherapy. This is a treatment that gets your immune cells to fight your cancer. All patients will receive sargramostim (GM-CSF) to prevent neutropenia--a low white blood cell count that increases your risk for infection.

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane (CONTESSA 2) (NCT03858972)

Summary

To take part in this study you must have locally advanced (some stage III) or metastatic (stage IV) breast cancer that is ER positive and HER2 negative and have not been previously treated with a taxane.

This study is investigating the effects (good or bad) of tesetaxel when used with a reduced dose of capecitabine (Xeloda®). Tesetaxel is a new type of taxane chemotherapy drug that can be taken by mouth. The taxanes that are currently approved are all given intraveneously (IV). Xeloda® is an oral chemotherapy drug approved to treat advanced breast cancer.

Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer (NCT02530489)

Summary

MPDL3280A (atezolizumab) is an new immunotherapy drug that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death ligand-1 (PD-L1) 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 looking at the safety and effectiveness of using atezolizumab and Abraxane before surgery and then using atezolizumab after surgery to treat stage I-III triple-negative breast cancer. Participants must have not had significant tumor shrinkage from enrollment in another study at M.D. Anderson (NCT02276443) to be eligible for this study.

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial (NCT03878524)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer.

This study is assessing the safety and feasibility of having a tumor board select therapy combinations for each individual patient. The tumor board will make a personalized treatment decision by evaluating the tumor's genetic profile. The board will choose among 35 types of targeted therapy, immunotherapy, or chemotherapy. This study also is enrolling patients with other types of cancer. This type of study is called a basket trial.

A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (NCT02755272)

Summary

To take part in this study, you must have metastatic triple negative (ER-/PR-/HER2-negative) breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug that gets the immune system to seek out cancer cells. It is used to treat advanced melanoma and metastatic non-small cell lung cancer. Researchers want to learn how well Keytruda works with chemotherapy to treat metastatic triple negative breast cancer. In this study, Keytruda will be combined with two chemotherapy drugs currently used to treat advanced breast cancer that has not responded to other chemotherapy drugs: carboplatin (Paraplatin®) and gemcitabine (Gemzar®).

A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT02734290)

Summary

This study is looking at the safety and effectiveness of using an immunotherapy drug along with a chemotherapy drug to treat breast cancer that cannot be removed by surgery. The immunotherapy drug is pembrolizumab (Keytruda®). It gets the body's immune system to go after cancer cells. The chemotherapy drug will be paclitaxel (Taxol®) or capacitabine (Xeloda®), depending on which group you are put in. Both drugs are commonly used to treat advanced breast cancer. To take part in this study, you must have advanced triple negative breast cancer.

A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer (NCT02788981)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. In addition, your tumor sample must test positive for glucocorticoid receptors (GR). This study will determine the safety and effects (good and bad) of using chemotherapy along with a steroid to treat advanced or metastatic triple negative breast cancer. The chemotherapy drug being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat advanced breast cancer. The steroid being used in this study is mifepristone. Researchers believe blocking the glucocorticoid receptor may make chemotherapy more effective.

A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers (NCT03058289)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have at least one tumor that can be felt by your doctor or seen on a scan by your radiologist. You also must have tried all other available treatments. INT230-6 is a combination chemotherapy treatment that is injected directly into the tumor. The first part of this study will determine the best dose of INT230-6. The second part will investigate how tumors respond to the best dose of INT230-6 when it is given with an anti-PD-1 immunotherapy. INT230-6 contains the chemotherapy drugs cisplatin (Platinol®) and vinblastine (Velban®) along with a substance that makes them more effective. This study is also recruiting patients with other types of advanced cancers.

"Randomized Trial of Partial Breast Irradiation (PBI) and Sequential vs. Concurrent Chemotherapy in Women With ER Negative Early Stage Breast Cancer (PBI 3.0)" (NCT01928589)

Summary

Following surgery, patients with ER-negative breast cancer typically receive radiation followed by chemotherapy. Previous studies suggest that giving radiation therapy and chemotherapy at the same time is also a safe and effective way to treat early-stage ER-negative breast cancer. Partial-breast irradiation (PBI) is a type of radiation therapy given only to the area of the breast where the cancer was removed. This study will compare the safety and effectiveness of giving PBI and chemotherapy at the same time with giving PBI followed by chemotherapy in patients with early-stage ER-negative breast cancer.

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer (NCT02752685)

Summary

Researchers are trying to see which treatment combinations are best for HER2 negative breast cancer. This study is looking at the safety and effectiveness of using a chemotherapy drug along with an immunotherapy drug. The chemotherapy drug is nab-paclitaxel (Abraxane®), which is used to treat advanced breast cancer. The immunotherapy drug is pembrolizumab (Keytruda®), which gets the immune system to go after cancer cells. To take part in this study, you must have metastatic breast cancer that is HER2-negative.

Clinical Phase Ib Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (NCT02834403)

Summary

Scientists have created new drugs to treat triple negative(ER-, PR-, HER2-) breast cancer. One of these new drugs is called L-NMMA. In this study, researchers will determine the best dose, safety and effectiveness of L-NMMA when it is given with a chemotherapy drug that is used to treat advanced breast cancer. The chemotherapy drug being used is docetaxel (Taxotere®). L-NMMA targets the NOS (nitric oxide synthase) inhibitor. To take part in this study, you must have metastatic triple negative breast cancer or stage III triple negative breast cancer that has already been treated with at least one other chemotherapy drug.

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (NCT03992131)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with at least one standard therapy.

This study is investigating the safety and effects (good and bad) of the combination of rucaparib (Rubraca®) and sacituzumab govitecan. Rubraca is a PARP inhibitor approved to treat recurrent ovarian, fallopian tube, and primary peritoneal cancer. Sacituzumab govitecan is a type of cancer therapy called an antibody-drug conjugate. It uses an antibody that targets cancer cells to deliver the drug SN-38 directly to these cells.

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) (NCT02996825)

Summary

To take part in this study you must have stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. This study is testing the safety and effects (good or bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy drug gemcitabine (Gemzar®). Mirvetuximab soravtansine is an antibody drug conjugate (ADC). It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy drug soravtansine directly to the tumor. Gemzar® is a chemotherapy drug approved to treat metastatic breast cancer. This study also is enrolling patients with other types of FR+ tumors.
This is a Phase I trial

Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer (NCT03125928)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study will evaluate the safety and effectiveness of adding an immunotherapy to the standard treatment for HER2-positive advanced breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It is approved to treat bladder cancer and a type of lung cancer. The standard of care for HER2+ advanced breast cancer treatment is the chemotherapy drug paclitaxel (Taxol®) and the HER2-targeted drugs trastuzumab (Herceptin®) and pertuzumab (Perjeta®).
This is a Phase II trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer) (NCT03280563)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib/Ibrance®, ribociclib/LEE011, or abemaciclib/LY2835219, that your cancer progressed on or did not respond to. This trial is studying 5 different treatment options. Women will receive one, two, or three of the following drugs: the immunotherapy atezolizumab (Tecentriq®), a PD-L1 (programmed cell death-ligand 1) inhibitor approved to treat certain types of bladder and lung cancer; the targeted therapy cobimetinib (Cotellic), which blocks the MEK protein and is approved to treat certain types of melanoma; fulvestrant (Faslodex®), a standard chemotherapy used to treat breast cancer; ipatasertib (GDC-0068), a new type of cancer drug that works by blocking the Akt protein; bevacizumab (Avastin), a monoclonal antibody that keeps tumors from growing the blood vessels they need to survive and is used to treat HER2-negative metastatic breast cancer.

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NeoPACT) (NCT03639948)

Summary

To take part in this study you must be a woman or man with stage I, II or III triple-negative (ER-/PR-/HER2-) breast cancer who has not yet started treatment.

This study is investigating the effect of using the immunotherapy pembrolizumab (Keytruda®) along with chemotherapy before surgery (neoadjuvant therapy). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and docetaxel (Taxotere®) are chemotherapy drugs used to treat triple negative breast cancer. Pegfilgrastim is a human granulocyte colony-stimulating factor (GCSF). It is given along with chemotherapy to reduce the risk of neutropenia (low white blood cell count) and infection.

A Phase I-II Study of Interferon-gamma Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer (NCT03112590)

Summary

To take part in this study, you must have HER2-positive breast cancer. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you are eligible for phase I of this study. If you have stage II-III breast cancer, you are eligible for phase II of this study. This study is evaluating the safety, effects (good and bad) and best dose of Actimmune® (IFN-γ 1b) when it is used along with paclitaxel (Taxol®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®) to treat HER2+ breast cancer. Actimmune is a protein made in the laboratory that is similar to interferon-gamma (IFN-γ), a protein produced by the body's immune cells to prevent infection.
This is a Phase I-II trial

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (NCT03125902)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer and not yet started treatment. This study is investigating whether a chemotherapy drug works better when it is given along with an immunotherapy. The chemotherapy drug being used in this study is paclitaxel (Taxol®). It is used to treat breast cancer. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that is currently approved to treat certain types of bladder and lung cancer.

A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab (NCT03414658)

Summary

To take part in this study, you must have HER2 positive advanced (stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of three different drug combinations in advanced HER2 positive breast cancer. The drugs being used in this study are: trastuzumab (Herceptin®), vinorelbine (Navelbine®) avelumab (Bevancio®) and utomilumab (PF-05082566). Herceptin is a targeted therapy routinely used to treat HER2-positive breast cancer. Navelbine®) is a chemotherapy drug used to treat HER2-positive breast cancer. Avelumab (Bevancio®) and utomilumab (PF-05082566) are immunotherapies that work by stimulating the body's immune system to go after cancer cells. Both work by blocking a protein called PD-L1. Bevancio is approved to treat metastatic Merkel cell carcinoma and urothelial (bladder) cancers. It's use is considered experimental in breast cancer. Utomilumab is an experimental treatment.

A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First- or Second-line Metastatic Triple-negative Breast Cancer (NCT03414684)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effects (good and bad) of giving the chemotherapy drug carboplatin (Paraplatin®) alone or with an immunotherapy drug to treat advanced breast cancer. Paraplatin is a chemotherapy drug routinely used to treat advanced breast cancer. The immunotherapy drug used in this study is the PD-1 inhibitor nivolumab (Opdivo®). The drug, which has been approved to treat certain types of cancer, but not breast cancer, stimulates the body's immune system to attack cancer cells by blocking a protein called PD-1 (programmed cell death 1).

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC) (NCT03213041)

Summary

To take part in this study, you must have HER2-negative stage IV (metastatic) breast cancer and a blood test that shows you have a circulating tumor cell (CTC) level ≥ 5. This study is investigating the safety and effects (good or bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug. The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a type of immunotherapy called a PD-1 inhibitor. The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic breast cancer.

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy (NCT02422498)

Summary

Researchers are studying the best way to treat triple-negative (ER-, PR-, HER2-) breast cancer. Cisplatin (Platinol®) is a platinum-based chemotherapy drug being studied in patients with triple-negative breast cancer. Radiation therapy can be used to treat cancer cells that have spread to different parts of the body. Researchers have developed a test that they think can be used to predict how well a patient's tumor will respond to concurrent cisplatin and radiation therapy. The test is performed on a biopsy (tissue sample) of the tumor, taken from the breast or elsewhere in the body. In this study, researchers will evaluate how well the test predicts response to cisplatin and radiation therapy in patients with recurrent (stage III) or metastatic (stage IV) triple-negative breast cancer. The biopsy and radiation will be given at Memorial Sloan Kettering Cancer Center.

A Randomized Phase II Study of Neoadjuvant Carboplatin/Paclitaxel (CT) Versus Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen for Newly Diagnosed Primary Triple-Negative Inflammatory Breast Cancer (NCT02876107)

Summary

To take part in this study, you must be newly diagnosed with stage III, inflammatory triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether chemotherapy combinations used to treat advanced breast cancer are more effective when given along with a targeted drug. The treatments are given before you have surgery. The initial chemotherapy combination is carboplatin (Paraplatin®) and paclitaxel (Taxol®). It is followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC. The targeted drug is panitumumab (Vectibix®). It is currently used to treat a certain type of metastatic colorectal cancer. It is not yet known if Vectibix will be effective as a breast cancer treatment.

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (NCT02779855)

Summary

To take part in this study, you must be newly diagnosed with stage II or III triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating the best dose of the drug talimogene laherparepvec (Imlygic™) to use along with chemotherapy before surgery. (Treatment before surgery is called neoadjuvant therapy.) Imlygic is a herpes virus that has been genetically modified to destroy cancer cells. It also works as an immunotherapy. The drug, which is injected directly into the tumor, is approved for treating melanoma. It will not cause you to develop herpes. The chemotherapy regimen that will be used in this study is ACT (doxorubicin/Adriamycin®, cyclophosphamide/Cytoxan®, paclitaxel/Taxol®). It is routinely used to treat triple negative breast cancer.

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer (NCT03498716)

Summary

To take part in this study, you must have stage II-III triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effectiveness of using an immunotherapy drug along with chemotherapy to chemotherapy alone to treat stage II-III triple negative breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It gets the immune system to attack cancer cells by blocking a protein called PD-L1 (programmed cell death-ligand 1). It is used to treat some lung and bladder cancers. Your first chemotherapy drug will be paclitaxel (Taxol®). It will be followed by dose-dense chemotherapy. Your doctor will decide if you receive doxorubicin (Adriamycin®) or epirubicin (Ellence®) and cyclophosphamide (Cytoxan®). You will also receive GM-CSF (sargramostim) or G-CSF (filgrastim) to prevent neutropenia--a low white blood cell count that increases your risk for infection.

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC (CONTESSA TRIO) (NCT03952325)

Summary

To take part in the first cohort, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have not received prior chemotherapy for advanced disease. To be part of the second cohort, you must be age 65 or older, have advanced or metastatic HER2 negative breast cancer, and have not received prior chemotherapy for advanced disease.

In the first cohort, this study is comparing the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs. In the second cohort, the study is investigating the safety and effects (good and bad) of tesetaxel when it is given alone. The three immunotherapy drugs being used in this study are nivolumab (Opdivo®), pembrolizumab (Keytruda®), and atezolizumab (Tecentriq®). Opdivo and Keytruda are PD-1 inhibitors. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Both are approved for certain types of cancers. Their use in breast cancer is considered experimental. Tecentriq is a PD-L1 inhibitor. It gets the immune system to go after cancer cells by blocking PD-L1. Tecentriq in combination with Abraxane is an FDA-approved treatment for metastatic triple negative breast cancer.

Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane (CONTESSA) (NCT03326674)

Summary

To take part in this study, you must have HER2-negative, hormone receptor-positive locally advanced or metastatic breast cancer. For your current diagnosis of locally advanced or metastatic breast cancer, you must have had no more than 1 chemotherapy. You also must have previously been treated with a taxane before being diagnosed with advanced breast cancer. This study is investigating whether using tesetaxel along with a reduced dose of capecitabine is more effective than using capacitabine alone to treat HER2-, HR+ locally advanced or metastatic breast cancer. Tesetaxel is a new type of oral taxane. Capacitabine is an oral chemotherapy drug used to treat breast cancer.
This is a Phase III trial

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.

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease (NCT03095352)

Summary

To take part in this study, you must have locally recurrent (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by surgery. This study is comparing the safety and effects (good and bad) of giving immunotherapy along with chemotherapy to giving chemotherapy and a placebo to treat breast cancer that has spread to the chest wall. Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a PDL-1 inhibitor approved to treat certain types of cancers. Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.

A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors (NCT03595059)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer.

This study will evaluate the safety of a new cancer drug, determine the best dose of the drug to use, and look at the effects (good and bad) of the best dose.The experimental drug is called ABBV-155. It is only available in clinical trials. ABBV-155 will be given with paclitaxel (Taxol®) a drug approved to treat breast cancer. This study is also enrolling patients with other types of cancer.

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) (NCT03424005)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. This study is investigating the safety and effectiveness of 7 different immunotherapy-based treatment combinations in women and men with triple negative (ER-/PR-/HER2-) breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of urinary, bladder and lung cancer. The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®). The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response (NCT03096418)

Summary

To take part in this study, you must have recently been diagnosed with early stage (stage I-III) breast cancer that can be removed by surgery. You must not yet had any cancer treatments. In this study, a chemotherapy drug will be given before surgery. Giving chemotherapy before surgery (called neoadjuvant treatment) can shrink the tumor. It also permits researchers to study whether the drug works better in certain types of tumors. The chemotherapy drug being used in this study is paclitaxel (Taxol®). It is commonly used to treat breast cancer.

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail (NCT02422641)

Summary

To take part in this study you must have metastatic breast cancer with leptomeningeal metastases.

This study is evaluating the effects (good and bad) of using high-dose methotrexate to treat metastases that shows up in the cerebrospinal fluid surrounding the brain and spinal cord and/or in the leptomeninges, the lining of the brain and spinal cord. This type of metastasis is called leptomeningeal disease. Methotrexate is a chemotherapy drug approved to treat advanced breast cancer. Researchers believe methotrexate can cross the blood-brain barrier to be effective in patients with leptomeningeal metastases.

A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer (NCT02776917)

Summary

To take part in this study, you must have triple negative (ER-, PR-, or HER2-) or hormone receptor positive (ER+ or PR+), advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of a new type of targeted therapy when it is given along with the chemotherapy drug paclitaxel (Taxol®) to treat advanced breast cancer. The experimental targeted therapy is cirmtuzumab. It blocks proteins found only on cancer cells. Taxol is commonly used to treat breast cancer.
This is a Phase I trial

Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)(NCT03535701)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer.

This study is investigating whether a ketogenic diet helps the chemotherapy drug paclitaxel (Taxol®) control tumor growth. A ketogenic diet is a low-carbohydrate diet. Eating fewer carbohydrates forces the body to burn stored fat. Laboratory studies suggest being on a ketogenic diet may reduce inflammation and help chemotherapy drugs control tumor growth. Taxol is a chemotherapy drug routinely used to treat breast cancer.

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy (NCT03487666)

Summary

To take part in this study, you must have triple negative (ER-, PR-, and HER2-), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage (stage I, stage II or stage III) breast cancer that was treated with chemotherapy before surgery (neoadjuvant treatment). You must not have been treated with capecitabine (Xeloda®) and you must have had tumor cells found in your breast or in your lymph nodes during surgery.

In this study, researchers will compare the effects (good and bad) of using two drugs alone or together after surgery. The two drugs being used in this study are nivolumab (Opdivo®) and capecitabine (Xeloda®). Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. Xeloda is a chemotherapy drug used to treat breast cancer.

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer (NCT03412877)

Summary

To take a part in this study, you must have metastatic (stage IV) breast cancer for which standard treatments have not worked.

This study is investigating the safety and effects (good or bad) of an immunotherapy that uses personalized T cells. To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. The cancer cells will be analyzed to learn about the genetic mutations they contain. In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. They will then be infused into your body. This will take place in the hospital where the research study is taking place. When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). This trial also is enrolling patients with other types of metastatic cancer.

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens (NCT03901339)

Summary

To take part in this study you must have HER2 negative, estrogen receptor positive metastatic (stage IV) breast cancer that has already been treated with 2, 3 or 4 different chemotherapy regimens.

This study is comparing the safety and effects (good and bad) of an investigational chemotherapy with standard of care chemotherapy. The investigational chemotherapy is called sacituzumab govitecan (IMMU-132). It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The antibody in this drug targets Trop-2 proteins. It delivers the chemotherapy drug SN-38.

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NCT03199885)

Summary

To take part in this study you must be starting treatment for metastatic (stage IV) breast cancer or have had your breast cancer recur after 6 months of neoadjuvant or adjuvant HER2-targeted therapy.

This study is comparing the safety and effects of the combination of pembrolizumab, trastuzumab, paclitaxel, and atezolizumab with the combination of pembrolizumab, trastuzumab, paclitaxel, and a placebo. Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Trastuzumab (Herceptin®) is a HER2-targeted therapy used to treat HER2-positive breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors (NCT03861403)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative (ER- PR- HER2-) or be postmenopausal and have advanced or metastatic estrogen receptor positive (ER+) breast cancer. This study is evaluating the safety and effects (good or bad) of giving TRX518, avelumab (Bavencio®), and cyclophosphamide (Cytoxan®) at the same time. TRX518 is an experimental immunotherapy that targets a protein found on immune cells called glucocorticoid-induced TNF-superfamily receptor (GITR). Bavencio is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat some types of cancer. Its use in breast cancer is considered experimental. Cytoxan is a chemotherapy drug used to treat breast cancer. This trial is also enrolling patients with other types of cancer.
This is a Phase I-II trial

Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer (NCT02876302)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) stage III inflammatory breast cancer. This study is designed to learn the safety and effects (good and bad) of using a new targeted drug along with chemotherapy to treat inflammatory breast cancer. The targeted drug is ruxolitinib (Jakafi®). It is used to treat myelofibrosis, a disease of the bone marrow. Laboratory studies suggest Jakafi may make chemotherapy more effective. The chemotherapy drugs that will be used in this study are paclitaxel (Taxol®), doxorubicin (Adriamycin®) and cyclophosophamide (Cytoxan®).

A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer (NCT03501979)

Summary

To take part in this study you must have HER2 positive metastatic breast cancer with leptomeningeal metastases. This is when the cancer spreads to the membranes lining the brain and spinal cord.

This study will look at the safety and effects (good and bad) of using tucatinib along with trastuzumab (Herceptin®) and capecitabine (Xeloda®). Tucatinib is a new type of HER2 inhibitor being studied in clinical trials. Herceptin is a HER2 targeted therapy. Xeloda is a type of chemotherapy. Herceptin and Xeloda are used to treat metastatic breast cancer.

A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer (NCT03301350)

Summary

To take part in this study, you must be diagnosed with stage I, stage II, or stage III triple negative (ER-,PR-,HER2-) breast cancer. This study is evaluating the safety and effects (good and bad) of using a regimen of low-dose weekly chemotherapy followed by dose-dense chemotherapy before surgery. The low-dose chemotherapy will be carboplatin (Paraplatin®) and paclitaxel (Taxol®). The dose-dense chemotherapy will be doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®). All of these drugs are approved to treat early-stage breast cancer. Women and men who take part in this study will also receive pegfilgrastim (Neulasta®) or filgrastim to prevent neutropenia--a very low white blood cell count.

Phase II Clinical Trial of Treatment With TAK-228 and TAK-117 to Inhibit Homologous Recombination (HR) Followed by Cisplatin and Nab Paclitaxel in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer (NCT03193853)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. Your tumor must also test negative for androgen receptors. In addition, you must have already had chemotherapy (anthracycline, cyclophosphamide, and taxane). This study is investigating the safety and effects (good or bad) of using two targeted drugs followed by chemotherapy to treat triple negative metastatic breast cancer. The targeted drugs used in this study are TAK-228 and TAK-117. Both are mTOR inhibitors. Cisplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are the chemotherapy drugs used in this study.

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.

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03150810)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study will investigate the safety and effects (good or bad) of using an oral chemotherapy along with a new targeted drug to treat advanced breast cancer. The two drugs being used in this study are temozolomide (Temodar) and BGB-290. Temodar is used to treat brain cancer. BGB-290 is a type of targeted therapy called a PARP inhibitor.

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo (NCT03281954)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-), early stage (stage I-III) breast cancer. This study is comparing the safety and effects (good or bad) of using an immunotherapy and the standard of care chemotherapy with using a placebo and the standard of care chemotherapy before and after surgery to treat early-stage triple negative breast cancer. The immunotherapy used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor approved to treat certain types of bladder and lung cancer. It works by blocking the PD-L1 (programmed cell death-ligand 1) protein.The standard of care chemotherapy drugs used in this study are paclitaxel (Taxol®) and carboplatin (Paraplatin®) followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) or epirubicin (Ellence®) and cyclophosphamide.

A Phase 1b Study of Neratinib, Pertuzumab and Trastuzumab With Taxol (3HT) in Primary Metastatic and Locally Advanced Breast Cancer, and Phase II Study of 3HT Followed by AC in HER2 + Primary IBC, and Neratinib With Taxol (NT) Followed by AC in HR+ /HER2- Primary IBC (NCT03101748)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. If you have inflammatory breast cancer, your tumor must be ER-positive to be eligible for this study. This study is investigating the safety and best dose of neratinib (Nerlynx®) to add to drug regimens used to treat advanced breast cancer. Neratinib is a tyrosine kinase inhibitor approved for use in patients with early-stage HER2-positive breast cancer who have already received trastuzumab (Herceptin®). The HER2-targeted drugs used in this study are pertuzumab (Perjeta®) and Herceptin. The chemotherapy drugs used in this study are doxorubicin/Adriamicin® and cyclophosphamide/Cytoxan®. Your treatment regimen will be determined by whether your tumor is HER2+ or HER2- and if you have inflammatory breast cancer. Women with inflammatory breast cancer will also have surgery.
This is a Phase I-II trial

A Phase II Trial of Atezolizumab (Anti-PDL1) With Carboplatin in Patients With Metastatic Triple Negative Breast Cancer (NCT03206203)

Summary

To take part in this study, you must have metastatic (stage IV), triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether using a combination of immunotherapy and chemotherapy is better than using chemotherapy alone to treat triple negative metastatic breast cancer. Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study.

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer (NCT03371017)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of giving chemotherapy with an immunotherapy to giving chemotherapy with a placebo. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). The chemotherapy drugs used in this study are gemcitabine (Gemzar®), carboplatin (Paraplatin®) and capecitabine (Xeloda®). Gemzar is a chemotherapy drug used to treat breast cancer. Paraplatin is a platinum-based chemotherapy drug that is commonly used to treat triple negative breast cancer. Xeloda is commonly used to treat metastatic breast cancer.

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC (NCT03321981)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and a tumor that is HER2-positive or ER-positive with low HER2-expression. This study is evaluating the effects (good or bad) of an experimental immunotherapy drug called MCLA-128. If your tumor is HER2+, you will receive MCLA-128 along with the HER2-targeted drug trastuzumab (Herceptin®). If you are ER+, you will receive MCLA-128 along with the same endocrine therapy you received before entering the study: fulvestrant (Faslodex®), exemestane (Aromasin®), letrozole (Femara®) or anastrozole (Arimidex®). The chemotherapy drug used in this study is vinorelbine (Navelbine®).
This is a Phase II trial

Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery (NCT03190967)

Summary

To take part in this study, you must have HER2-positive breast cancer and have brain mets that have returned after treatment with radiation and/or surgery. The brain mets must have been treated with stereotactic radiation or surgery within 6 weeks of starting treatment on the trial. This study is investigating the safety and effects (good and bad) of using a targeted therapy along with chemotherapy to treat HER2-positive breast cancer that has spread (metastasized) to the brain. The targeted therapy used in this study is T-DM1 (Kadcyla®). It is used to treat HER2-positive metastatic breast cancer. It combines the chemotherapy drug DM1 with the HER2-targeted drug trastuzumab (Herceptin®). The chemotherapy drug used in this study is temozolomide (Temodar®). It is used to treat brain cancer. If you participate in this study you will have at least two lumbar punctures (spinal taps). During this procedure, a needle is inserted into the spinal canal in the lower back to collect cerebrospinal fluid. You will receive local anesthesia and imaging will be used to guide the procedure.

A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer (NCT02999477)

Summary

To take part in this study, you must have HR-positive (ER+ and/or PR+), HER2-negative stage II or III breast cancer that can be removed by surgery. This study is investigating the safety and effect of different combinations of Keytruda® and Abraxane® when they are given before surgery to patients with stage II or III breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug. It gets the body's immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). It is currently approved to treat certain types of melanoma, head and neck cancer, lung cancer and Hodgkin lymphoma. Nab-paclitaxel (Abraxane®) is a chemotherapy drug approved to treat metastatic breast cancer in patents who have already tried other cancer treatments.
This is a Phase I trial

A Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer (OPERA) (NCT03326102)

Summary

To take part in this study you must have HER2-negative recurrent or metastatic (stage IV) breast cancer that has been treated with up to three lines of therapy other than a taxane.

This study is comparing the safety and effects (good and bad) of paclitaxel taken by mouth with paclitaxel that is given through a vein (IV). The IV form of paclitaxel (Taxol®) is approved to treat metastatic breast cancer in the U.S. The oral form (DHP107) is approved to treat metastatic breast cancer in Korea. There it is sold as Liporaxel®.

Phase Ib/II Study of Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer (NCT03377387)

Summary

To take part in this study, you must have HER2-positive metastatic (stage IV) breast cancer. This study is investigating the safety and effect (good or bad) of using a targeted therapy in combination with different doses of a standard chemotherapy. The targeted therapy that is being used in this study is neratinib (Nerlynx®). It is approved to treat certain patients with HER2+ early-stage breast cancer. Capacitabine (Xeloda®) is approved by the FDA for treating advanced breast cancer.
This is a Phase I-II trial

BRE-01: Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel Followed by Doxorubicin and Cyclophosphamide in Triple Negative Breast Cancer (NCT04083963)

Summary

To take part in this study you must be a woman with early-stage (stage II and some stage IIII) triple negative (ER-, PR- and HER2-) breast cancer who has not yet started cancer treatment and who is expected to have breast cancer surgery.

This study is evaluating the safety and effects (good and bad) of adding a low dose of the chemotherapy drug paraplatin (Carboplatin®) to the standard of care neoadjuvant chemotherapy regimen for triple negative tumors. The standard of care regimen includes these three chemotherapy drugs: paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxan®). All of the chemotherapy drugs being used in this study are approved to treat 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.

Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART) (NCT00948285)

Summary

Breast conserving surgery removes the the tumor along with a rim of normal tissue (a surgical margin). Magnetic resonance imaging (MRI) is not currently used before surgery to help define the surgical area. This study will evaluate whether using MRI along with mammography and ultrasound is more effective than using mammography and ultrasound alone before surgery to obtain clean margins, reduce the need for a second surgery, and achieve a good cosmetic result. To be eligible, a woman must be a candidate for breast conserving surgery (lumpectomy).

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial (NCT02926911)

Summary

To take part in this study, you must have recently been diagnosed with hormone receptor-positive (ER+/PR+) DCIS and not yet started treatment. Not all DCIS will go on to become invasive breast cancer. This means that some women being treated for DCIS are getting more treatment than is necessary. This study will compare active surveillance--a mammogram every six months and optional anti-estrogen therapy--to the standard of care for treating DCIS. The standard of care is surgery, which may be followed by radiation and/or anti-estrogen treatment. For more information. email: thomas.lynch2@duke.edu

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

Summary

Cryoablation uses extreme cold to destroy cancerous tumors. The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276°F) to freeze and kill the breast tumor. The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm). This study is looking at how well cryoablation works to prevent local recurrence in women 50 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer. To be eligible for this study, a woman must have a tumor that is classified as Luminal A on a core needle biopsy.

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery (NCT03113825)

Summary

To take part in this study, you must have been newly diagnosed with DCIS or early stage (stage I-III) breast cancer and scheduled to breast cancer surgery. This surgery must be a lumpectomy with sentinel lymph node biopsy or axillary lymph node dissection, or a mastectomy with axillary lymph node dissection. AVB-620 is a type of dye that is absorbed by potentially cancerous tissue, tumor margins, or lymph nodes. In this study, researchers will evaluate the safety and effects (good and bad) of giving AVB-620 before surgery to help your surgeon distinguish between cancerous and non-cancerous tissues.

Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction (NCT02725801)

Summary

During breast reconstruction, a tissue expander is put into the chest wall. The expander is filled with saline (salt water) through a port to gradually stretch the skin and make space for the implant. The traditional type of expander has one port. AlloX2® is a new type of expander that has two ports: one port fills the expander and the other drains seroma, the clear bodily fluids that develops where the breast has been removed. In this study, half of the women will receive the regular one-port expander and the other half will receive the two-port expander. This will allow the researcher to see whether women have a better outcome or less complications when using a one-port or two-port expander. To be eligible, a woman must be planning to have immediate tissue expander breast reconstruction following her mastectomy.

Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer (NCT02927912)

Summary

To take part in this study, you must have recently been diagnosed with stage I or II breast cancer and be planning to have breast conserving surgery (lumpectomy) and reconstruction. This study is evaluating the effectiveness and side effects (good and bad) of delivering radiation therapy during surgery. Intraoperative Electron Therapy (IOERT) is the radiation treatment used during surgery. It delivers a concentrated beam of radiation directly to the area where the tumor was removed.

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy (NCT01185132)

Summary

Women whose breast cancer is removed by lumpectomy almost always receive radiation after surgery. Intensity-modulated radiation therapy (IMRT) is a type of high-precision radiotherapy that delivers focused, high-dose radiation to the tumor, while reducing spread to the surrounding normal breast and lung tissue. The goal of this trial is to compare the effectiveness of intensity-modulated radiation therapy with standard radiation therapy. To be eligible, participants must have had or be planning to have a lumpectomy followed by radiation.

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial (NCT01688388)

Summary

The standard treatment for early stage breast cancer is breast conserving surgery (lumpectomy) followed by breast radiation. The radiation treatment is typically given over three to five weeks followed by between five and eight daily radiation treatments that are focused on the site where the lump was removed. Researchers believe that giving this full radiation treatment during surgery may be equally effective. This study is evaluating the safety and effectiveness of giving this single dose of radiation during breast cancer surgery.

Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341)

Summary

Photon radiation therapy is the standard X-ray radiation therapy used to treat breast cancer. Proton radiation therapy is a type of radiation treatment that delivers radiation more directly to the cancer cells, making it less likely to damage nearby normal tissues. It is often used to treat brain tumors. This study is comparing the side effects and effectiveness of photon radiation to proton radiation when it is used to treat DCIS or stage I-III breast cancer. To be eligible, a patient must be between the ages of 21 and 65 and have had a lumpectomy or a mastectomy.

A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response (NCT02482376)

Summary

Giving radiation before surgery allows researchers to study how cancer cells respond to radiation treatments. Stereotactic body radiation therapy (SBRT) is a type of radiation treatment that delivers a high dose of radiation directly to the tumor. This reduces the risk of damaging healthy breast tissue. In this study, researchers will compare cancer cells found in a breast biopsy done before the radiation treatment is given with cancer cells removed during breast conserving surgery (lumpectomy). To take part, you must have ER-positive, HER2-negative DCIS or stage I breast cancer and be 60 years of age or older. If you are between the ages of 50 and 59, you can take part if you have a low Oncotype DX score (0-17).

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial (NCT02332928)

Summary

Fatigue is a common side effect of radiation therapy. Melatonin is a hormone made naturally by the body that helps regulate sleep and wake cycles. Researchers think giving melatonin supplements to women before, during, and after their radiation therapy may help reduce fatigue. This study is comparing the effectiveness of melatonin supplements to a placebo in women receiving radiation as part of their breast cancer treatment.

Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer (NCT02685332)

Summary

To take part in this study, you must have been diagnosed with DCIS (ductal carcinoma in situ) or some early stage (stage I or II) breast cancer. You must also have had a lumpectomy (breast conserving surgery) and be planning on having radiation. Radiation is used after surgery to kill any breast cancer cells that may be left in the breast. This study will help researchers learn whether it is safe to use a type of radiation called Cyberknife® to treat breast cancer. The study will also help researchers learn the best dose of Cyberknife radiation to use. Cyberknife radiation is a type of radiation treatment that delivers a high dose of radiation over a short period of time to a targeted area.

A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease (NCT03808662)

Summary

To take part in this study you must have oligoprogessive metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has progressed on at least one other systemic treatment.

Patients with oligoprogressive metastatic breast cancer have a small number of metastatic tumors in one or two other parts of the body. This study will compare the safety and effects (good or bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases followed by a standard of care treatment to a standard of care treatment alone. SBRT uses multiple radiation beams to deliver high doses of precision radiation directly to the tumor.

Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial (NCT00909909)

Summary

Ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy followed by radiation. Post-lumpectomy radiation usually involves whole breast radiation (WBI), followed by a radiation boost targeted directly to the site where the DCIS or early-stage cancer was located. Individuals who receive a mastectomy may also, in some cases, receive radiation therapy as well. These standard radiation treatments are usually given five days a week for up to seven weeks. Accelerated hypofractionated radiation involves giving larger doses of radiation in fewer sessions over a shorter period of time. The goal of this trial is to study the effectiveness and side effects associated with three different accelerated radiation treatments in women with DCIS or early-stage breast cancer who have had or will be having a lumpectomy or mastectomy.

Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction (NCT01400399)

Summary

Breast conservation surgery followed by radiation therapy is an established treatment for early stage breast cancer. Breast conservation surgery refers to either lumpectomy, or bilateral reduction mammoplasty (BRM). Lumpectomy involves removal of the tumor with a small amount of surrounding normal tissue. With BRM, a larger margin of normal tissue around the tumor is removed and the opposite breast is surgically reduced in size to maintain symmetry. All women in this study will have either lumpectomy or BRM followed by approximately 3 weeks of radiation treatment (hypofractionated). This data collection trial will evaluate the cosmetic outcome and factors contributing to cosmetic outcome in women treated with lumpectomy or BRM followed by hypofractionated radiation (larger doses (fractions) of radiation in fewer sessions over a shorter period of time). To be eligible participants must be at least 50 years old, diagnosed with DCIS or early stage breast cancer, with no lymph node involvement.

An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After Lumpectomy for Breast Cancer in Women With a High Risk of Local Recurrence. (NCT01792726)

Summary

Targeted intraoperative radiotherapy (TARGIT) is given during surgery immediately after the tumor has been removed. This allows the radiation to directly target the tissue bed--the area where the tumor was located--where the risk of recurrence is highest. External beam radiation therapy (EBRT) is given after surgery and is the standard radiation therapy used following a lumpectomy. This study is comparing the effectiveness of TARGIT to standard EBRT in women undergoing lumpectomy (breast conserving surgery) for stage I-III breast cancer who are at a high risk of having their cancer recur in the breast.

Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy (NCT02945579)

Summary

To take part in this study, you must be age 40 or older and have stage I-II breast cancer that is HER2+ or triple-negative (ER-/PR-/HER2-). You must also have already had chemotherapy to shrink your tumor, but no other treatments. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. The tumor may even disappear. When this occurs, researchers think it may be possible for patients to avoid surgery. This study is looking at whether radiation alone keeps cancer from recurring in women whose biopsy after completing chemotherapy shows no evidence of disease.

Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions (NCT02755896)

Summary

During partial breast irradiation (PBI), the radiation beam is directed to the area of the breast where the cancer was removed. Radiation fibrosis—the hardening of breast tissue—is one side effect of radiation therapy. This fibrosis can cause ongoing discomfort. This study is comparing the effectiveness and side effects (including the development of fibrosis) of two different schedules and doses of PBI therapy in women age 50 and older with stage I breast cancer. To be eligible, a woman must be postmenopausal and have had a lumpectomy.

The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer (NCT02653755)

Summary

Most women receive radiation therapy after a lumpectomy (also called breast conserving surgery). Prosigna is a genetic test used on tumor tissue. It tells you how likely it is your breast cancer will come back in a location other than your breast (called a distant recurrence or metastases). This study is looking at whether women who are at low risk of having their cancer come back can skip radiation. To take part, you must have had a lumpectomy with negative margins. In addition, your tumor must be hormone sensitive (ER+ and/or PR+) and HER2-negative.
This is a Phase II trial

Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation (NCT02728076)

Summary

To take part in this study, you must have stage I-IIa hormone-sensitive (ER-positive and/or PR-positive) beast cancer. Giving radiation before surgery allows researchers to study how cancer cells respond to radiation treatments. Accelerated partial breast irradiation (APBI) is a type of radiation treatment that delivers a high dose of radiation directly to the tumor. This type of radiation treatment is less likely to damage healthy breast tissue. A CT (computed tomography) scan is typically used to plan the radiation treatment. Researchers think using MRI (magnetic resonance imaging) to plan the radiation treatment may lead to a better outcome. This study is looking at whether it is effective to use MRI with APBI to treat early-stage breast cancer.

Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT) (NCT01295723)

Summary

Radiation therapy is used following a lumpectomy to destroy any cancer cells that may be left in the breast after surgery. It usually consists of 3-5 weeks of daily whole breast radiation therapy, followed by a “boost” of 5-8 daily radiation treatments targeted directly to the site where the tumor was located. Intraoperative radiation therapy with electrons (IOERT) is a new technique that gives intensive radiation therapy during surgery to the area where the tumor was removed. The purpose of this study is to evaluate the safety and effectiveness of using IOERT in individuals with Stage I or II breast cancer who go on to receive three weeks of whole breast radiation therapy. To be eligible, participants must be planning to have a lumpectomy.

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery (NCT01570998)

Summary

Radiation is used to kill any breast cancer cells that may not have been removed during surgery. Targeted intraoperative radiotherapy is delivered during surgery immediately after the tumor has been removed. This allows the radiation to accurately target the tissue surrounding the tumor, where the risk of recurrence is highest. It takes about 20-35 minutes to provide intraoperative radiotherapy. This study, the Targeted Intraoperative Radiotherapy Trial (TARGIT), will follow women who receive this type of radiation therapy for five years, allowing researchers to study its effectiveness and side effects. This registry trial is open to patients who are receiving a lumpectomy (breast conserving surgery) and who are considered to be at low risk of having a local recurrence. If indicated, participants will also receive whole breast radiation.

A Prospective Study of Partial Breast Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors (NCT01089374)

Summary

Phyllodes tumors are a very rare type of breast tumor. They tend to be large and to grow very quickly. When patients with phyllodes tumors who have been treated with a lumpectomy experience a recurrence, it is almost always at the original tumor site. This is why researchers believe partial breast radiation is likely to be as effective as whole breast radiation for treating malignant phyllodes tumors. The purpose of this study is to determine what the chances are that a phyllodes tumor will recur in the breast when the breast is treated with partial breast radiation therapy after a lumpectomy. To be eligible, participants must be diagnosed with a borderline or malignant grade phyllodes tumor.

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer (NCT02364557)

Summary

When breast cancer spreads to only one or two locations in the body, it is referred to as limited metastatic (oligometastatic) breast cancer. Stereotactic body radiation therapy (SBRT) delivers a high dose of radiation directly to the tumor, reducing the risk of damaging surrounding healthy tissue. Researchers think SRBT may be a promising treatment for women with limited metastases. This study is comparing the effectiveness of using SRBT along with systemic therapy to systemic therapy alone for treating women with newly diagnosed and limited metastases.

Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer (NCT02366806)

Summary

The standard of care for treating early-stage breast cancer is a lumpectomy followed by radiation. Prior to starting radiation, patients typically receive general information about radiation therapy and its potential side effects. An in-depth, personalized treatment education plan may be more beneficial. This study will compare the benefits of a standard radiation education plan to a personalized radiation education plan in patients with early-stage breast cancer. To be eligible, a patient must be scheduled to receive radiation therapy for early-stage breast cancer at the University of California, Davis.

Optimizing Preventative Adjuvant Linac-based Radiation: the OPAL Trial A Phase II Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer (NCT03077841)

Summary

To take part, you must be age 50 or older and have recently been diagnosed with DCIS or stage I or II breast cancer. If you have stage I or II breast cancer, your tumor must be ER-positive. This study is evaluating the effects (good and bad) of hypofractionated radiation. This type of radiation treatment delivers larger doses of radiation in less amount of time than standard radiation therapy.

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer (NCT02400658)

Summary

Breast conserving surgery (lumpectomy) followed by radiation therapy is a standard treatment for early-stage breast cancer. Intraoperative radiation therapy (IORT) delivers a high dose of radiation guided by CT-imaging during surgery to the area in the breast where the tumor was removed. This study is evaluating the effectiveness of IORT in women with early-stage breast cancer who are age 45 or older and have a tumor less than or equal to 3cm.

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (NCT01901094)

Summary

Researchers are studying the best way to treat women who have received neoadjuvant therapy (treatment given before surgery) and are found to have a positive sentinel node(s) during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery. Axillary lymph node dissection (ALND) removes tumor cells that have spread to nearby lymph nodes or other nodes in the axillary (armpit) area. This study is comparing the effectiveness of ALND plus radiation therapy to radiation therapy alone in treating women who had neoadjuvant treatment and were found to have a positive sentinel node(s) during surgery.

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction (NCT03414970)

Summary

To take part in this study, you must have had a mastectomy to treat stage II or III (stage IIa-IIIb) breast cancer. This study is comparing the safety and effectiveness of hypofractionated radiation therapy to standard radiation therapy in women and men who have had a mastectomy to treat stage IIa-IIIb breast cancer. Hypofractionated radiation is a type of radiation therapy in which larger doses (fractions) of radiation are given in fewer sessions over a shorter period of time than conventional radiation therapy.

A FEASIBILITY AND PHASE II TRIAL OF ACCELERATED PARTIAL BREAST IRRADIATION USING PROTON THERAPY FOR WOMEN WITH STAGE IA-IIA BREAST CANCER (NCT01839838)

Summary

Standard X-ray radiation uses particles called photons to kill tumor cells. Proton therapy is an alternative type of radiation therapy that uses particles called protons. Studies suggest that proton radiation may result in fewer side effects than traditional X-ray radiation. Accelerated partial breast irradiation (APBI) delivers a highly effective dose of radiation to the tumor bed over a shortened time period. This trial is studying the effectiveness of using proton therapy to treat women with stage IA-IIA node-negative, hormone-sensitive tumors following a lumpectomy.

A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer (NCT02701244)

Summary

To take part in this study, you must be age 50 or older and have had breast conserving surgery (lumpectomy) along with an axillary node dissection (minimum 6 nodes sampled) or sentinel lymph node biopsy for DCIS or early stage (stage I-III) breast cancer. This study is investigating the safety and effects (good and bad) of a permanent breast seed implant (PBSI) radiation technique for treating women with DCIS or early-stage breast cancer. PBSI involves implanting radioactive seeds in a portion of the breast, allowing the patient to live a normal life while the seeds deliver the prescribed radiation to the breast. Researchers think that PBSI is a safe and effective alternative to traditional forms of radiation for women who have had a lumpectomy and lymph node dissection or sentinel lymph node biopsy.