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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.

An Open-label Phase 1b Study of ARQ 092 in Combination With Carboplatin Plus Paclitaxel in Subjects With Selected Solid Tumors (NCT02476955)

Summary

ARQ092 is a new type of targeted therapy called an AKT inhibitor. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs used to treat advanced breast cancer. Researchers will evaluate the safety and efficacy of using ARQ092 in combination with Paraplatin and Taxol for treating advanced triple-negative breast cancer (and other solid tumors).

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.

A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer (NCT03451162)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. In this study, researchers will evaluate the safety, best dose, and effects (good and bad) of an experimental therapy called DHES0815A for treating HER2-positive metastatic breast cancer.

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.

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).

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.

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 Phase I Study of TAK-228 (MLN0128) in Combination With Carboplatin Plus Paclitaxel in Patients With Advanced Malignancies (NCT03430882)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. In this study, researchers will determine the safety and effects (good and bad) of treating women and men with advanced breast cancer with an investigational targeted therapy and chemotherapy. The targeted therapy is TAK-228. It is only available in clinical trials. It is a type of targeted therapy called an mTOR inhibitor. The chemotherapy drugs used in this trial are paclitaxel (Taxol®) and carboplatin (Paraplatin®). Both are approved to treat advanced breast cancer. Trial participants will be asked to monitor their glucose levels at home using a glucose monitor (a glucometer), which will be provided by the research site.

Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer (NCT02624700)

Summary

Pemetrexed (Alimta®) is a chemotherapy drug approved to treat non-small cell lung cancer. Early studies suggest it may also be effective for treating breast cancer. Sorafenib (Nexavar®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is used to treat liver, kidney and thyroid cancer. Researchers think it may be effective for triple-negative breast cancer. This study is investigating the safety and effectiveness of using Alimta and Nexavar to treat recurrent or metastatic triple-negative breast 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.

Multi-center Phase IB Trial of ACY-1215 (Ricolinostat) Combined With Nab-paclitaxel in Unresectable or Metastatic Breast Cancer (NCT02632071)

Summary

ACY-1215 (ricolinostat) is an experimental targeted therapy that works by blocking a protein called HDAC6 (histone deacetylase 6), which helps cancer cells grow. It is currently being studied as a treatment for a type of blood cancer called multiple myeloma. Researchers think ricolinostat may be an effective breast cancer treatment. Nab-paclitaxel (Abraxane®) is a taxane-based chemotherapy drug routinely used to treat advanced breast cancer. This study is evaluating the safety and tolerability of using Abraxane with varying doses of ricolinostat to treat advanced breast cancer.

CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery (NCT02547987)

Summary

Carboplatin (Paraplatin®) is the only platinum-based chemotherapy drug used to treat breast cancer. It is currently used to treat advanced breast cancer. Previous studies have suggested it may be effective against stage I-III, triple-negative breast cancer. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to see how the drug effects the breast tumor. This study is evaluating the safety and effectiveness of using Paraplatin and Taxotere before surgery to treat stage I-III triple-negative breast cancer.

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 II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients (NCT02654119)

Summary

Researchers want to learn which drug combination is most likely to keep HER2-positive breast cancer from coming back. This study is looking at the safety and effectiveness of treating stage I-II HER2-positive breast cancer with cyclophosphamide (Cytoxan®), paclitaxel (Taxol®) and trastuzumab (Herceptin®) after surgery. To take part, you must have HER2-positive, stage I-II breast cancer. You cannot have been treated with chemotherapy in the past. And you cannot have been diagnosed with peripheral neuropathy (tingling or pain in the hands or feet). Cytoxan and Taxol are two chemotherapy drugs used to treat breast cancer. Herceptin is a HER2-targeted therapy.

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.

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.

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.

Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen (NCT02698891)

Summary

If you receive chemotherapy, you may develop an infection. Pegfilgrastim (Neulasta®) is given to reduce this risk. ACT (doxorubicin/Adriamycin®, cyclophosphamide/Cytoxan® and paclitaxel/Taxol®) are three chemotherapy drugs often used together to treat breast cancer. Researchers think it may be possible to give ACT without Neulasta during the Taxol portion to avoid its side effects, including bone pain. In this study, you will receive dose-dense Taxol after finishing dose-dense AC and only get Neuslasta if you begin to develop a fever with infection and low blood counts or need to delay Taxol due to low blood counts. To take part, you may be at any point during AC treatment, but have not yet started Taxol treatment. In this study, you will receive dose-dense chemotherapy. This means you will have chemotherapy treatments that are scheduled closer together, such as every 2 weeks apart instead of every 3 weeks.

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.

Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer (NCT02595905)

Summary

Cisplatin (Platinol®) is a chemotherapy drug used to treat metastatic breast cancer. Researchers want to know if Platinol kills more cancer cells when it is given alone or with other drugs. In this study, researchers will see if Platiniol works better when it is given with veliparib. This drug is a new type of targeted treatment called a PARP inhibitor. To take part in this study, you must have metastatic triple negative (ER-, PR- and HER2-) breast cancer or have an inherited BRCA mutation and metastatic HER2-negative breast cancer.

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.

Phase II Study of The Efficacy And Safety of Chloroquine (C) in CombinAtion With Taxane or Taxane-like (T) Chemo Agents in The Treatment of Patients With Advanced or Metastatic Breast Cancer Who Have Failed Anthracycline Chemo Base Therapy. (NCT01446016)

Summary

Chloroquine is a drug that is commonly used to prevent and treat malaria. Studies suggest that chloroquine may also be an effective cancer treatment. Researchers believe this may be because chloroquine targets a special type of tumor cell called a tumor-initiating cell, which may not respond to chemotherapy. The goal of this study is to determine the safety and effectiveness of chloroquine when it is given with a taxane chemotherapy drug to individuals with metastatic disease. To be eligible, participants must have previously progressed on a chemotherapy regimen that included an anthracycline like Adriamycin® or Doxil®.

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.

T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy (NCT02957968)

Summary

To take part in this study, you must have HER2-negative locally advanced (some stage III) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) can shrink the tumor. It also allows researchers to study the effect the treatment has on the cancer cells. This study will evaluate the safety and effectiveness of using immunotherapy before standard neoadjuvant chemotherapy. The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of metastatic lung cancer. It will be given along with the chemotherapy drug decitabine (Dacogen®), which is used to treat a certain type of blood cancer.

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).

A Phase I/Ib Dose-escalation Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumor Malignancies and Assessment of MYC Oncogene Overexpression (NCT01676753)

Summary

Scientists are developing new targeted therapies that have the potential to be effective against breast and other solid tumors. Dinaciclib is an investigational drug that inhibits cyclin-dependent kinases (CDKs). Paclitaxel (Taxol ®) is a drug routinely used to treat advanced breast cancer. Combining dinaciclib with Taxol may make cancer cells more likely to respond to Taxol. The purpose of this trial is to collect safety data for the combination of weekly Taxol and dinaciclib in patients with advanced breast cancer (and other types of solid tumors). After the dose is determined, the researchers will expand the trial by enrolling 12 patients with advanced triple-negative breast cancer. The researchers will also try to identify biomarkers that can predict which tumors will respond to dinaciclib.

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 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.

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®).

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

Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Chemotherapy (NCT02891681)

Summary

To take part in this study, you must be newly diagnosed with advanced (some stage III) breast cancer and be planning to receive chemotherapy before you have surgery. This is called neoadjuvant treatment. Researchers are studying different ways to monitor how tumors respond to chemotherapy given before surgery. This study is investigating whether using ultrasound and near infrared imaging is an effective way to see how a tumor is responding to treatment.

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 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 I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer (NCT01697293)

Summary

Researchers are studying new drugs and new drug combinations for treating locally advanced breast cancer. Triciribine Phosphate Monohydrate (TCN-PM) is a type of new cancer drug called an AKT inhibitor. AKT is a protein that plays a role in cell growth and cell death. In cancer cells, this protein is not working properly, which helps the tumor grow and spread. The researchers think that giving TCN-PM along with the chemotherapy drug paclitaxel (followed later in time by additional chemotherapy) may be more effective than paclitaxel alone. This study is looking at the affect that giving TCN-PM along with paclitaxel has on HER2-negative locally advanced breast tumors. The first phase of this trial will also enroll patients with stage IV (metastatic) breast cancer.

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 Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab [MEDI4736]) Plus Anti-CTLA-4 Antibody (Tremelimumab) in Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT03132467)

Summary

To take part in this study, you must have HR-positive (ER+/PR+) and HER2-negative stage II or stage III breast cancer. You must also be planning to receive treatment before surgery (called neoadjuvant treatment). This study is investigating the the safety and effects (good and bad) that two immunotherapy drugs have on breast tumors when given before surgery. The two immunotherapy drugs are tremelimumab and duralumab (Imfinzi). Tremelimumab has not been approved for any types of cancer. Imfinzi is approved to treat a certain type of bladder cancer.

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.

CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer (NCT02827370)

Summary

To take part in this study, you must have been diagnosed with early stage breast cancer but not yet had surgery. This study is looking at whether a dietary intervention that will be determined based on your tumor's genomic characteristics changes the effect that chemotherapy given before surgery has on your cancer cells. Giving chemotherapy before surgery, called neoadjuvant treatment, allows researchers to study the effect a treatment had on the cancer cells after the tumor has been removed. Your tumor's genomic characteristics will be analyzed at the beginning of the study and after you have surgery.

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

A Phase Ib Study Evaluating the Safety and Tolerability of Durvalumab (MEDI4736) (Anti-PDL1) in Combination With Eribulin in Patients With HER2-Negative Metastatic Breast Cancer and Recurrent Ovarian Cancer (NCT03430518)

Summary

To take part in this study you must be a woman or man with HER2 negative metastatic (stage IV) breast cancer.

This study will determine the best dose of eribulin (Halaven®) to use with durvalumab (Infinzi®). Halaven is a chemotherapy drug used to treat patients who have already had at least two other therapies for their metastatic breast cancer and were previously treated with an anthracycline and a taxane for either early or advanced breast cancer. Infinzi is an immunotherapy drug. It gets the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed cell death ligand-1). It is currently approved to treat patients with certain types of lung and urinary cancers. This study also is enrolling women with ovarian cancer.

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

Summary

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

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

Phase 1b Study of HSP90 Inhibitor, AT13387 in Combination With Paclitaxel in Patients With Advanced, Triple Negative Breast Cancer(NCT02474173)

Summary

To take part, you must have some stage III-IV triple negative (ER-/PR-/HER2-negative) breast cancer. Researchers have developed a new type of drug called an HSP90 inhibitor. The HSP90 inhibitor being used in this study is named AT13387. This study is investigating whether AT13387 helps kill cancer cells and what side effects women experience when they are given it along with paclitaxel (Taxol®). AT13387 is a new drug that is only available in clinical trials. Taxol is a chemotherapy drug used to treat breast cancer.

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

Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors (NCT02762981)

Summary

To take part in this study, you must be have stage III or stage IV breast cancer. This study is investigating the safety and effectiveness of using the approved breast cancer drug nab-paclitaxel (Abraxane®) along with a new drug called CORT125134. The new drug, CORT125134, is a type of drug called a glucocorticoid receptor antagonist. It is available only in clinical trials.

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.

Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer (NCT03121352)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You cannot have had more than two prior therapies for your metastatic diagnosis. This study will determine the effectiveness of giving two chemotherapy drugs along with an immunotherapy drug. The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is approved to treat some types of metastatic cancer. Carboplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are chemotherapy drugs routinely used to treat advanced breast cancer.

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).

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.

Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer (NCT02186470)

Summary

Radiation is usually given after breast cancer surgery. Researchers think giving radiation before removing the breast tumor--called breast conserving surgery or lumpectomy--will shrink the tumor. If it does, then less breast tissue will need to be removed during surgery. This study is using accelerated partial breast irradiation (APBI), a type of radiation therapy that delivers high dose of radiation directly to the tumor. To take part, you must be 60 years or older, and have hormone-sensitive ductal carcinoma in situ (DCIS) or stage I breast cancer.

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.

MC1631: A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation (NCT02783690)

Summary

To take part in this study, you must have stage I, II or III breast cancer and have had a mastectomy. You must be planning to start radiation to the chest wall and regional nodes. In addition, it must be less than 12 weeks since you had surgery or your last chemotherapy treatment (if you are having chemotherapy). This study is comparing the safety and effectiveness of two different doses of pencil beam proton radiation, a standard dose and a lower dose. Most radiation therapy for breast cancer uses x-rays, which contain photons. Protons, which are being used in this study, can be aimed more directly at the tumor than photons. This means there may be fewer side effects from proton radiation. The pencil beam scan used to deliver the radiation is available only through the Mayo Clinic.

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.

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer (NCT01960803)

Summary

Researchers are studying new ways to give radiation therapy during or after breast cancer surgery. Intraoperative Electron Radiation Treatment (IOERT) is a radiation treatment that delivers a concentrated beam of radiation directly to the tumor bed. This study is investigating the feasibility and tolerability of giving a single dose of IOERT at the time of breast conserving surgery to patients with early stage breast cancer. To be eligible, patients must be scheduled to have a lumpectomy for stage I, II or III breast cancer.

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.

Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain (NCT01621906)

Summary

Researchers are trying to develop better methods for evaluating how brain metastases respond to whole brain radiation therapy (WBRT). This study is comparing a positron emission tomography (PET) scanner with a magnetic resonance imaging (MRI) scanner. A PET scanner resembles a CT or MRI scanner. PET scans use radioactive substances, called radioactive markers, to "see" cancer cells. This study will use [18F]FLT as the radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. (It differs from FDG-PET, which is more commonly used.) This study will help researchers determine whether the FLT PET scan is safe and more effective for evaluating brain metastases than MRI. To be eligible participants must be planning on receiving WBRT.

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.

Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer (NCT02370797)

Summary

Intraoperative Electron Therapy (IOERT) is a radiation treatment used during surgery to deliver a concentrated beam of radiation directly to the area where the tumor was removed. This study will investigate the effectiveness of IOERT for preventing a local recurrence in women who are having a lumpectomy. To be eligible, a woman must be clinically node-negative.

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.

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer (NCT01766297)

Summary

Radiation is used after surgery to kill any cancer cells that may have been left in the breast. Proton therapy is a form of external beam radiation that uses protons (instead of x-rays) to treat the tumor. Because the proton beam can be more directly targeted to the tumor, proton therapy may result in fewer side effects than x-ray radiation. This study is investigating the safety, effectiveness, and side effects of proton radiotherapy when it is used to treat women with DCIS or early- stage breast cancer.