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Targeted therapy

Targeted therapies work by attacking specific molecules in cancer cells. Targeted therapy is being studied in early stage and advanced breast cancer.

Istodax and Platinol for Advanced BRCA+ or Triple Negative Breast Cancer

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.


This is a Phase I-II trial

Chemotherapy, Her2 Targeted Therapy & Immunotherapy Before Surgery in HER2+ Breast Cancer

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

Summary

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

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


This is a Phase II trial

MM-310 for Metastatic Triple Negative Breast Cancer

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.


This is a Phase I trial

Chemotherapy & HER2-Targeted Therapies Before Surgery for HER2+ Stage I-III 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.


This is a Phase II trial

Carboplatin and Afinitor for Metastatic Triple-Negative Breast Cancer

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.


This is a Phase II trial

Rebastinib plus Chemotherapy for Metastatic Breast Cancer

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.


This is a Phase I trial

Vectibix, Paraplatin & Taxol Before Surgery For Early Stage Triple Negative Disease

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.


This is a Phase II trial

TVB-2640 with Taxol and Herceptin for HER2+ Advanced Breast Cancer

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

Summary

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


This is a Phase II trial

AZD8186 and Docetaxel for Advanced Breast Cancer with PTEN or PIK3C-beta Mutations

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.


This is a Phase I trial

Doxil, Avastin and Torisel Before Surgery for Triple-Negative Breast Cancer

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

Summary

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


This is a Phase II trial

Rebastinib and Paclitaxel in Women and Men with Metastatic Breast Cancer

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.


This is a Phase I-II trial

Ipatasertib and Taxol for HER2- Advanced 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.


This is a Phase II-III trial

Ibrance with Cisplatin or Carboplatin for Advanced Breast (and Other) Cancer

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.


This is a Phase I trial

Ribocilcib and Taxol in Metastatic Breast Cancer with the Rb Protein

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.


This is a Phase I trial

Chemotherapy Plus Herceptin After Surgery for Stage I-II HER2+ Breast Cancer

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.


This is a Phase II trial

Galunisertib and Taxol for Metastatic Triple Negative Breast Cancer

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.


This is a Phase I trial

L-NMMA plus Taxotere for Advanced Triple Negative Breast Cancer

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.


This is a Phase I-II trial

Platinol plus Veliparib for Recurrent or Metastatic HER2- Breast Cancer

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.


This is a Phase II trial

Mirvetuximab Soravtansine & Chemotherapy in FRa+ Metastatic Triple Negative Breast Cancer

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

Summary

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

Tecentriq plus Taxol, Herceptin and Perjeta for HER2+ Advanced 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

Combination of Immunotherapy and Targeted Therapies for HR+ and HER2- Breast 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 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.


This is a Phase I-II trial

Actimmune with Taxol, Herceptin & Perjeta for HER2+ Breast Cancer

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

Herceptin and Navelbine With Immunotherapy for Advanced HER2+ Breast 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.


This is a Phase II trial

Vectibix and Chemotherapy Before Surgery for Triple Negative Inflammatory Breast Cancer

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.


This is a Phase II trial

ABBV-155 for Advanced Breast (and Other) Cancers

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.


This is a Phase I trial

Tecentriq & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast 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®).


This is a Phase I-II trial

A New Targeted Therapy and Taxol for Advanced Breast Cancer

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

Paclitaxel, Trastuzumab, Pertuzumab With or Without Atezolizumab For HER2+ Metastatic Breast Cancer

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

Summary

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

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


This is a Phase III trial

Jakafi and Chemo Before Surgery for Stage III Triple Negative Inflammatory Breast 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®).


This is a Phase II trial

Triciribine & Paclitaxel in Stage II-III HER2 Negative Tumors

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.


This is a Phase I-II trial

Targeted therapy followed by Chemotherapy for Metastatic Triple Negative 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.


This is a Phase II trial

BGB-290 with Temozolomide for Advanced Breast (and Other) 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.


This is a Phase I-II trial

Adding Neratinib to Treatment Regimens for Advanced or Inflammatory Breast Cancer

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

MCLA-128, Herceptin & Chemo or Hormone Therapy for HER2+ or ER+/Low HER2 Breast Cancer

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

Summary

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

Kadcyla and Temodar for Recurrent HER2+ Brain Metastases from Breast Cancer

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.


This is a Phase I-II trial

HSP90 Inhibitor and Taxol for Advanced Triple Negative Breast Cancer

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.


This is a Phase I trial

Neratinib and Xeloda for Metastatic HER2+ 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

CORT125134 and Abraxane for Advanced Breast Cancer

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.


This is a Phase I-II trial

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

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

Summary

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


This is a Phase II trial

D-0502 Alone or in Combination With Ibrance in ER+, HER2- Advanced Breast Cancer

A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (NCT03471663)

Summary

To take part in this study, you must have ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, effects (good and bad) and best dose of an experimental anti-estrogen therapy when it is given alone or in combination with palbociclib (Ibrance®). D-0502 is the experimental anti-estrogen therapy used in this study. Ibrance®) is approved to treat hormone sensitive, HER2 negative breast cancer in combination with an anti-estrogen therapy in postmenopausal women. If you are premenopausal, you will also be given a therapy that will stop your ovaries from producing estrogen.


This is a Phase I trial

Sunitinib for Metastatic HER2+ Breast Cancer That Has Progressed on HER2+ Therapies

A Two-part Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients With HER2 Positive Solid Tumors Who Failed Prior HER2 Targeted Therapy (NCT02500199)

Summary

Researchers are studying new ways to treat metastatic HER2+ breast cancer that has stopped responding to HER2-targeted therapies. Pyrotinib, a tyrosine kinase inhibitor, is an experimental targeted therapy. It targets both HER1 and HER2. In this study, researchers are investigating the safety, effectiveness and the best dose of pyrotinib to treat HER2+ metastatic breast cancer that has stopped responding to other HER2-targeted therapies. To be eligible, participants must have had their cancer progress after having been on at least two prior HER2-targeted therapies, including trastuzumab (Herceptin®) and/or pertuzumab (Perjeta®), or T-DM1 (Kadcyla®), or lapatinib (Tykerb®).
This is a Phase I trial

TAK-228 and Letrozole in Postmenopausal Women With High-Risk ER+ and HER2-Low Breast Cancer

Phase 1b Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer (NCT02619669)

Summary

To take part in this study you must be a postmenopausal woman with stage I, stage II, stage III or metastatic (stage IV) breast cancer that is estrogen receptor (ER) positive and low HER2 (defined as IHC 0-1+) and has a high risk for recurrence. This study is investigating the safety and effects (good or bad) of the combination of TAK-228 and letrozole (Femara®) when given before surgery. This is called neoadjuvant treatment. TAK-228 is a new type of targeted therapy called a TORC inhibitor. Femara® is a type of hormone therapy called an aromatase inhibitor. It is approved to treat postmenopausal women with breast cancer.
This is a Phase I trial

Targeted Therapy Rebastinib With Carboplatin for Advanced Breast Cancer

An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors (NCT03717415)

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 investigating the safety, dose and effects (good and bad) of the targeted therapy rebastinib (DCC-2036) when used along with carboplatin (Paraplatin®). Rebastinib targets a receptor called TIE2. Researchers believe blocking this protein will keep tumors from growing and spreading. Paraplatin is a chemotherapy drug routinely used to treat advanced and metastatic triple negative breast cancer.


This is a Phase I-II trial

Copanlisib, Letrozole, and Ibrance for HR+, HER2- Stage I-IV Breast Cancer

A Phase 1b Trial of LY2606368 in Combination With Chemotherapy or Targeted Agents in Advanced and/or Metastatic Tumors (NCT03128619)

Summary

To take part in this study, you must have ER+, HER2- early stage (stage I-III) or metastatic (stage IV) breast cancer. This trial has two phases. In phase one, researchers will determine the safety and best dose of the drug capanlisib when it is given with Femara to treat advanced (some stage III and IV) breast cancer. In phase two, researchers will compare the safety and effect of giving combinations of targeted therapies with a hormone therapy. Palbociclib (Ibrance®) and copanlisib are the targeted therapies used in this study. Ibrance targets the CDK4/6 protein. It is approved by the FDA to treat postmenopausal women with ER+, HER2- metastatic breast cancer. Copanlisib targets the PI3K protein. Copanlisib is approved to treat a certain type of blood cancer. Letrozole (Femara®) is the hormone therapy used in this study. It is approved to treat hormone-sensitive breast cancer
This is a Phase I-II trial

Talazoparib for HER2-Negative Advanced Breast Cancer

A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in... (NCT02401347)

Summary

Talazoparib (BMN 673) is a PARP inhibitor. Studies suggest PARP inhibitors may be effective in some types of breast cancer. Early studies suggest talazoparib may be effective in cancer patients who have an inherited BRCA1/2 mutation. It may also be effective in patients who do not have a BRCA1/2 mutation. This study is investigating the safety and effectiveness of talazoparib in patients with HER2-negative advanced breast cancer who do not have a BRCA1/2 mutation. To be eligible, participants must have advanced triple negative breast cancer or HER2-negative breast cancer with a mutation in another gene. Participants will have their tumor tested for genetic mutations to determine eligibility.


This is a Phase II trial

Faslodex, Ibrance & Erdafitinib for ER+, HER2-, Advanced Breast Cancer

A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC) (NCT03238196)

Summary

To take part in this study, you must have ER+, HER2- metastatic (stage IV) breast cancer. Your tumor will be tested to see if it is FGFR-amplified. It must be FGFR-amplified for you to take part in this study. This study is investigating the best dose, safety and effects (good or bad) of giving targeted therapies along with hormone therapy. Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. Erdafitinib (JNJ-42756493) is an experimental targeted therapy that works by targeting the FGFR tyrosine kinase protein. Fulvestrant (Faslodex®) is the hormone therapy used in this study. It is approved to treat metastatic breast cancer.
This is a Phase I trial

Tecentriq, Cotellic & Halaven for Metastatic Inflammatory Breast Cancer

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer (NCT03202316)

Summary

To take part in this study, you must have inflammatory advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a chemotherapy that your cancer progressed on or did not respond to. In this study, researchers will determine the safety and effect (good or bad) of using a combination of immunotherapy, targeted therapy and chemotherapy to control metastatic inflammatory breast cancer. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is FDA approved to treat certain types of bladder and lung cancer. Cobimetinib (Cotellic®) is a new targeted therapy called an MEK inhibitor. It is approved to treat certain types of melanoma. Eribulin (Halaven®) is a chemotherapy drug approved for treating metastatic breast cancer.


This is a Phase II trial

DHES0815A for Advanced HER2-Positive Breast Cancer

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. DHES0815A is an antibody-drug conjugate (ADC). It combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells.


This is a Phase I trial

Olaparib and Durvalumab in Metastatic Triple Negative Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer (NCT03801369)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer.

This study is evaluating the safety and effects (good or bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®). Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). It is approved to treat certain types of ovarian cancer. Imfinzi is a type of immunotherapy drug called a PD-L1 inhibitor. It gets the body's immune system to go after cancer cells. It is approved to treat certain types of lung cancer. Preclinical studies suggest this drug combination may be effective in patients with metastatic triple negative breast cancer.


This is a Phase II trial

Mirvetuximab Soravtansine for Triple Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Mirvetuximab Soravtansine in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NACT), Including a Lead-in Cohort to Establish Activity in Patients With Metastatic TNBC(NCT03106077)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) breast cancer. You must also have a tumor that express folate receptor alpha (FRα). Researchers will test your tumor for this receptor. This study will determine the safety and effects (good and bad) of using an experimental drug that targets FRα to treat early-stage or metastatic triple negative breast cancer. Studies suggest FRα helps tumors grow and spread. The experimental drug used is called mirvetuximab soravtansine (IMGN853).


This is a Phase II trial

Lynparza and Onalespib for Metastatic Triple Negative Breast Cancer

A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer (NCT02898207)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. This study will determine the safety and best dose of two targeted drugs for treating metastatic breast cancer. The two targeted drugs being used in this study are olaparib (Lynparza®) and onalespib (AT13387). Lynparza is a PARP inhibitor. It is approved by the FDA to treat ovarian cancer. Onalespib is an experimental HSP90 inhibitor. This trial is also enrolling patients with other types of cancers.


This is a Phase I trial

AB-ROR2-ADC for Advanced Breast Cancer

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors (NCT03504488)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies.

This study is investigating the safety and effects (good or bad) of an experimental drug called CAB-ROR2-ADC (BA3021). CAB-ROR2-ADC is a type of drug called an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The antibody in this drug targets ROR2 proteins. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I-II trial

SGN-LIV1A and Keytruda for Advanced Triple Negative Breast Cancer

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer (NCT03310957)

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 looking at the safety and effects (good or bad) of using SGN-LIV1A along with pembrolizumab (Keytruda®) to treat triple negative advanced or metastatic breast cancer. SGN-LIV1A is an investigational drug that targets a protein called LIV-1 that is found on some tumor cells. Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells. Keytruda is not approved to treat breast cancer. It is approved to treat certain other types of cancer.


This is a Phase I-II trial

Immunotherapy EDP1503 With Pembrolizumab For Advanced Triple Negative Breast Cancer

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (NCT03775850)

Summary

To take part in this study you must be a woman or man with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other approved treatment options available.

This study is assessing the safety and the effects (good or bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®). EDP1503 is an experimental immunotherapy that may work by changing the microenvironment that surrounds the cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is only approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

Avelumab Plus Talazoparib to Treat Advanced Breast Cancer

A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors (NCT03330405)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) or HR+, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy along with a targeted therapy to treat advanced breast cancer. The immunotherapy being used in this study is abelumab (Bavencio®). It works by blocking a protein called PD-L1 (programmed cell death-ligand 1). Talazoparib (BMN-637) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells. This study is also enrolling patients with other types of solid tumors.
This is a Phase II trial

Merestinib for Breast Cancer with Bone Metastases

An Exploratory Phase 1B Study to Assess the Effects of Merestinib on Bone Metastases in Subjects With Breast Cancer (NCT03292536)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer that has spread to the bone. This study will determine the safety and effects (good and bad) of using merestinib to treat bone metastasis. Merestinib (LY2801653) is a new type of targeted therapy called a c-met inhibitor.


This is a Phase I trial

Elacestrant for ER+ and HER2- Advanced Breast Cancer (EMERALD)

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial (NCT03778931)

Summary

To take part in this study you must have locally advanced (some stage III) or metastatic (stage IV) breast cancer that is ER positive and HER2 negative and you must have already been treated with a CDK4/6 inhibitor in combination with fulvestrant (Faslodex) or an aromatase inhibitor.

This study is comparing the effects (good and bad) of elacestrant to fulvestrant (Faslodex) or an aromatase inhibitor. Elacestrant is an investigational hormone therapy. It is expected to work in a similar way to fulvestrant, but is given once a day my mouth rather than by monthly injections. The study will also look at the effectiveness of elacestrant compared to other drugs in women and men with ER-positive breast cancer including those whose tumors have mutations in the ESR1 gene. Faslodex and aromatase inhibitors are used to treat metastatic breast cancer.


This is a Phase III trial

Herceptin for HER2-Positive Breast Cancer That Has Spread to the Brain

Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer (NCT02571530)

Summary

Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. It is delivered intravenously. However, the blood-brain barrier prevents much of the drug from getting to cancer cells that have spread to the brain. This study is evaluating the safety of administering a single dose of trastuzumab into an artery in the brain to treat HER2+ brain metastases.
This is a Phase I trial

Basket Study of Entrectinib in Tumors With a NTRK1/2/3, ROS1, or ALK Mutation

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements (NCT02568267)

Summary

Basket studies enroll patients based on the kind of mutations found in their tumors, rather than the type of cancer they have. This is a basket study of entrectinib (RXDX-101) in individuals with solid tumors that have an NTRK1/2/3, ROS1, or ALK gene rearrangement. To be eligible, a breast cancer patient must have a tumor that tests positive for a NTRK1/2/3, ROS1 or ALK rearrangement.


This is a Phase II trial

Gedatolisib plus PTK7-ADC for Metastatic Triple Negative Breast Cancer

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (NCT03243331)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of using two investigational drugs to treat metastatic triple negative breast cancer. The two drugs are gedatolisib and PTK7-ADC. Gedatolisib is a targeted therapy that works by blocking PI3K and mTOR kinase proteins, which play a role in the cellular pathways that help tumors grow. PTK7-ADC (PF-06647020) targets a protein called PTK7, which is often found on cancer cells. It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a drug that can kill these cells.


This is a Phase I trial

PF-05212384 + Other Drugs for Advanced ER+, HER2+ or Triple Negative Breast Cancer

A Phase 1B Open-Label Three-Arm Multi-Center Study To Assess The Safety And Tolerability Of PF-05212384 (PI3K/MTor Inhibitor) In Combination With Other Anti-Tumor Agents (NCT01920061)

Summary

Researchers are studying new drug combinations that could be used to treat advanced breast cancer. PKI-587 (PF-05212384) is a type of targeted therapy called an PI3K/mTOR inhibitor. It prevents cancer cells from growing by blocking PI3K and mTOR proteins. Docetaxel (Taxotere®) and cisplatin (Platinol®) are chemotherapy drugs that are routinely used to treat advanced breast cancer. Dacomitinib is a new type of HER2-targeted therapy that is currently being studied in clinical trials. This study is looking at the safety and effectiveness of using taxotere and PF-05212384 to treat advanced ER+ breast cancer; platinol and PF-05212384 to treat advanced triple negative breast cancer, and dacomitinb and PF-05212384 to treat advanced HER2+ breast cancer.
This is a Phase I trial

NCI-MATCH: Choosing the Best Drug for Metastatic Breast (and Other) Cancer

A Basket study: Molecular Analysis for Therapy Choice (MATCH) (NCT02465060)

Summary

Cancer cells grow because they have genetic mistakes (mutations) inside them. Scientists are developing cancer treatments that keep these mistakes from helping the cancer grow. The National Cancer Institute (NCI) started a trial called MATCH (Molecular Analysis for Therapy Choice). If you enroll in NCI-MATCH, the researchers will test your tumor (that's what they mean by molecular analysis) to see what genetic mistakes it contains. The researchers will then see if there is a cancer drug that is a good match for your tumor's genetic mistakes (that's what they mean by therapy choice). To take part in this study, you must have already had one treatment since learning you have metastatic breast cancer.


This is a Phase II trial

GEN1029 for Advanced Breast (and Other) Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors (NCT03576131)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with standard treatments or have no standard treatment available.

In this study, researchers will determine the best dose and effects (good and bad) of a new type of targeted cancer therapy called GEN1029 (HexaBody®-DR5/DR5). Patients with other types of cancers will also be enrolled in this study.


This is a Phase I-II trial

Ibrance & Casodex for Metastatic Triple Negative Breast Cancer with Androgen Receptors

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) (NCT02605486)

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen treatment. This study is testing the safety and effectiveness of using Ibrance and Casodex to treat triple negative breast cancer that is androgen receptor positive. To be eligible for this trial, participants must have triple negative, androgen receptor positive, metastatic breast cancer.


This is a Phase I-II trial

Radiation With or Without Tykerb® for HER2+ Brain Metastases

Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer (NCT01622868)

Summary

Whole-brain radiotherapy is the most frequently used therapy for breast cancer brain metastases. This is because most chemotherapy drugs are not able to cross the blood-brain barrier. Lapatinib (Tykerb®) is a kinase inhibitor that targets HER2 as well as the epidermal growth factor receptor (EGFR). It is used with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer in people who have already been treated with other chemotherapy drugs. It is unclear whether Tykerb is able to cross the blood-brain barrier. The purpose of this trial is to determine if whole-brain radiotherapy given along with Tykerb is more effective than whole-brain radiotherapy given alone.
This is a Phase II trial

Plaquenil and Afinitor to Prevent Breast Cancer Recurrence

CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer (NCT03032406)

Summary

To take part in this study, you must have been treated for HER2-negative stage II breast cancer within the past 5 years. In addition, your doctor must have found disseminated tumor cells (DTCs) in your bone marrow after you completed your first-line treatment. This study is investigating whether Plaquenil® alone, Afinitor alone, or a combination of the two drugs reduces the risk of recurrence in HER2-negative breast cancer survivors who have DTCs. Hydroxychloroquine (Plaquenil®) is a drug commonly used to prevent and treat malaria. Everolimus (Afinitor®) is a type of targeted drug called an mTOR inhibitor. It is used to treat advanced hormone receptor-positive, HER2-negative breast cancer.


This is a Phase II trial

Entinostat, Opdivo and Yervoy in Advanced HER2-Negative Breast Cancer

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors (NCT02453620)

Summary

Entinostat is a histone deacetylase (HDAC) inhibitor. It is designed to block HDAC enzymes, which are needed for cell growth. Nivolumab (Opdivo®) is an immunotherapy that blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 may allow the body’s own immune cells to attack cancer cells. It is approved for advanced lung cancer. Ipilimumab (Yervoy®) is an immunotherapy that stimulates T-cells in the body’s immune system. It is approved for treating patients with advanced melanoma. This trial is designed to identify the side effects and best dose of entinostat and Opdivo when the two drugs are given with Yervoy to treat advanced HER2-negative breast cancer.


This is a Phase I trial

Immunotherapy Plus a Targeted Drug for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589) (NCT02890069)

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. You must also have already received a treatment that your cancer progressed on or did not respond to. This study is looking at whether a new immunotherapy drug is safe and effective when given along with a targeted drug to patients with advanced or metastatic triple negative breast cancer. The immunotherapy drug used in this study is called PDR001. You will receive one of three targeted drugs: LCL161, everolimus (Afinitor®), or panobinostat (LBH589). This study is also enrolling patients with other types of cancer.


This is a Phase I trial

A HER2-Targeted Drug for Advanced HER2-Positive Breast Cancer

Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers (NCT02892123)

Summary

To take part in this study, you must have stage III or stage IV (metastatic) HER2-positive breast cancer and have already received at least one treatment for your cancer. This study is investigating whether a new type of HER2-targeted drug is safe and effective. It will also determine the most effective dose of the drug that can be used safely. The drug being studied is called ZW25. This study is also open to patients with other types of HER2-positive cancers.


This is a Phase I trial

Ribociclib with Hormone Therapy for ER+ Early Stage Breast Cancer

Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) (NCT03285412)

Summary

To take part in this study, you must have ER-positive, early stage (stage I-III) breast cancer.

In this study, researchers will compare the safety and effects (good and bad) of two different doses of the targeted drug ribociclib (Kisqali®) that will be given on two different schedules along with a hormone therapy. Kisqali is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer cells grow. It is FDA approved for use along with an aromatase inhibitor to treat advanced breast cancer. The hormone therapy you receive will be chosen by the physician leading the study.


This is a Phase II trial

CAR-T Cell Immunotherapy for Metastatic Breast Cancer That Tests CD70 Positive

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers (NCT02830724)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that tests positive for CD70 and you must have already been treated with a standard therapy. This study is investigating the safety and effects (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.
This is a Phase I-II trial

Durvalumab & Olaparib in Advanced Triple Negative Breast Cancer Treated with Chemotherapy

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (NCT03167619)

Summary

To take part in this study, you must have advanced (some stage III that is inoperable) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-), have already been treated with at least three cycles of a platinum-based chemotherapy and shown response, and have had no more than two prior chemotherapy regimens for metastatic breast cancer.

This study will compare the effects (good or bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug. Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. It is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain other types of cancers, and its use in breast cancer is considered experimental.


This is a Phase II trial

Effect of Xgeva on Breast Tissue in Women Treated for DCIS, Stage I-III Breast Cancer

Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers (NCT02613416)

Summary

Researchers are studying the relationship between breast density and breast cancer. Laboratory studies suggest a protein called the RANK ligand may be linked to breast density. Denosumab (Xgeva®) is an anti-RANK antibody that inhibits the RANK protein. In patients with bone metastases, Xgeva is used to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. This study will investigate the effect that Xgeva has on breast tissue in women who have completed treatment for DCIS or stage I, II or III breast cancer. This study is being conducted at the Stony Brook University Cancer Center in New York. For more information, call: 631-638-0852.


This is a Phase II trial

Xentuzumab With Everolimus and Exemestane in HR Positive and HER2 Negative Advanced Breast Cancer

XENERA™-1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease (NCT03659136)

Summary

To take part in this study you must be a postmenopausal woman with HR positive HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is to comparing the effect (good or bad) of the combination of xentuzamab, everolimus (Afinitor®), and exemestane (Aromasin®) to the combination of a placebo, Afinitor and Aromasin. Xentuzumab is an investigational targeted therapy that blocks insulin-like growth factor (IGF). Studies suggest it may improve how cancer cells respond to chemotherapy. Aromasin is an anti-estrogen drug used to treat breast cancer. Afinitor is a chemotherapy drug used to treat advanced HR positive HER2 negative breast cancer.


This is a Phase II trial

BLZ945 Alone or With PDR001 For Metastatic Breast (and Other) Cancer

A Basket Study: A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors (NCT02829723)

Summary

This study has two parts. To enroll in the first part, you must have metastatic breast cancer. To enroll in the second part, you must have metastatic triple negative breast cancer. This study is investigating whether a new type of targeted cancer drug is safe and effective when it is given alone or with an immunotherapy drug. This is the first study to test this new targeted drug in cancer patients. The targeted drug being used in this study is called BLZ945. It targets a receptor called CSF1R that plays a role in tumor growth. Some patients who enroll in this study will also receive an immunotherapy drug called PDR001. This study is also enrolling patients with other types of metastatic cancers.


This is a Phase I-II trial

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients (NCT03449238)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and at least two brain metastases.

This study is investigating the safety and effects (good or bad) of using pembrolizumab (Keytruda®) along with stereotactic radiosurgery (SRS) to treat breast cancer that has spread to the brain. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental. Stereotactic radiosurgery is not surgery. It is a type of radiation therapy that precisely targets metastases in the brain.


This is a Phase I-II trial

DS-8201a Versus T-DM1 for HER2-Positive Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] (NCT03529110)

Summary

To take part in this study, you must have HER2 positive, advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with T-DM1 (Kadcyla®).

This study is comparing the effects (good or bad) of an experimental HER2 targeted therapy called DS-8201 to the standard of care in patients with advanced breast cancer who have already been treated with the HER2 targeted therapy Kadcyla. DS-8201 is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The two standard of care options used in this study are the HER2 targeted therapy trastuzumab (Herceptin®) given with the chemotherapy drug capecitabine (Xeloda®) and the HER2-targeted therapy lapatinib (Tykerb®) given with Xeloda.


This is a Phase III trial

ONC201 for Estrogen Receptor Positive or Triple Negative Metastatic Breast Cancer

A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma (NCT03394027)

Summary

To take part in this study, you must have estrogen receptor positive or triple negative (ER-, PR- and HER2-) metastatic breast cancer.

This study will examine the safety and effectiveness of using an experimental drug called ONC201 to slow cancer growth. ONC201 is a new type of cancer drug called an impridone. This study is also enrolling women with advanced endometrial cancer.


This is a Phase II trial

Ibrance plus Femara or Faslodex for HR+, HER2- Metastatic Breast Cancer

A Phase II Clinical Trial Assessing the Safety of an Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer (NCT03007979)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative metastatic (stage IV) breast cancer. This study is evaluating a new dosing schedule for the targeted drug palbociclib (Ibrance®). If you are in this study you will receive Ibrance® for 5 days on with 2 days off, instead of the current standard schedule of 3 weeks on and 1 week off. You will also receive the anti-estrogen drugs letrozole (Femara®) and fulvestrant (Faslodex®). If you are premenopausal, you will receive a drug to shut down your ovaries.
This is a Phase II trial

A New Three-Drug Combination for HR+, HER2- Metastatic Breast Cancer

A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer (NCT02871791)

Summary

To take part in this study, you must have hormone sensitive (ER+ and/or PR+), HER2-negative metastatic breast cancer. Researchers think using three drugs that work in different ways will be an effective breast cancer treatment. The three drugs patients who enroll in this study will receive are palbociclib (Ibrance®), everolimus (Afinitor®) and exemestane (Aromasin®). The researchers will determine the best dose of each drug to use when the three drugs are given together. All three drugs are used to treat metastatic breast cancer. It is not known how well they work when given together. Ibrance is a targeted drug that blocks two proteins, CDK 4 and CDK 6. Afinitor is a targeted drug that blocks mTOR. Aromasin is an anti-estrogen drug.
This is a Phase I-II trial

Ribociclib and Immunotherapy to Treat Metastatic Breast Cancer

A Phase 1 Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Combination With the PD-1 Inhibitor PDR001 in Patients With Metastatic Hormone Receptor-positive Breast Cancer and Metastatic Ovarian Cancer (NCT03294694)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative.

This study is evaluating the safety and effects (good or bad) of using ribociclib (Kisqali®) along with an immunotherapy or an immunotherapy and a hormone therapy. Kisqali is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved for use along with an anti-estrogen therapy to treat HR-positive HER2-negative metastatic breast cancer. The aromatase inhibitor being used in this study is fulvestrant (Faslodex®). The immunotherapy being used in this study is spartalizumab (PDR001). It is a type of immunotherapy that targets PD-1. This study also is enrolling patients with metastatic ovarian cancer.


This is a Phase I trial

Study of MGD009 in Metastatic Breast (and other) Tumors With B7-H3

Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms (NCT02628535)

Summary

Scientists have found that many cancer cells have high levels of a protein called B7-H3. Blocking this protein may be an effective way to treat cancer. MGD009 is a new drug that recognizes B7-H3 on cancer cells. It works by getting immune cells to go after B7-H3-expressing cancer cells. This study is evaluating the safety, tolerability, and best dose of MGD009 for treating metastatic breast (and other) cancers that test positive for B7-H3. Patients will have their tumor tested for the B7-H3 protein. Those whose tumors test positive will be eligible for the study.


This is a Phase I trial

PF-05082566 With Kadcyla® or Trastuzumab For Advanced HER2 Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer (NCT03364348)

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 or bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin®). Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.


This is a Phase I trial

Study of U3-1402 for HER2 Negative, HER3 Positive Advanced Breast Cancer

Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer (NCT02980341)

Summary

To take part in this study you must have advanced (stage III) or metastatic (stage IV) breast cancer that is HER2 negative and HER3 positive and have had 2-6 prior chemotherapy regimens, at least 2 of which were for advanced cancer, and at least 1 that included a taxane.

This study will evaluate the safety, effects (good or bad) and best dose of U3 1402. This drug is an investigational antibody-drug conjugate (ADC). It uses an antibody that targets HER3 on cancer cells to deliver a chemotherapy drug called MAAA-1181a directly to these cells.


This is a Phase I-II trial

Xgeva Given Before Surgery to Study Effect on Cancer Cells

Pre-surgical Evaluation of Denosumab in Patients With Operable Invasive Breast Cancer

Summary

To take part in this study, you must have stage I, stage II or stage III breast cancer. You must also have had a core needle biopsy (a procedure in which a small piece of your tumor is removed). This study is looking at how a targeted therapy affects the proteins inside breast cancer cells. Denosumab (Xgeva®) is the targeted therapy used in this study. It is used to treat patients with breast cancer that has spread to the bone. Xgeva works by blocking a protein called RANK, which may help cancer cells spread to the bone. The drug is given before surgery so that researchers can study what it does to the RANK protein inside cancer cells.

Taselisib with HER2-Targeted Therapies for Advanced HER2+ Breast Cancer

Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer (NCT02390427)

Summary

Taselisib (GDC-0032) is a new type of drug called a PI3K inhibitor. It works by blocking the PI3K protein, which plays a role in cancer cell growth. Researchers think using Taselisib along with HER2-targeted therapies will be a more effective way to treat advanced HER2+ breast cancer. Pertuzumab (Perjeta®), trastuzumaub (Herceptin®), and T-DM1 (Kadcyla®) are three different HER2-targeted therapies. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. This study is looking at the safety, effectiveness, and best dose of taselisib when it is given along with one or more HER2-targeted therapies to patients with locally recurrent or metastatic HER2+ breast cancer.
This is a Phase I trial

Prexasertib and Lynparza in Patients With Advanced Breast (and Other) Cancer

A Basket Study: Phase 1 Combination Study of Prexasertib (LY2606368), CHK1 Inhibitor, and Olaparib, PARP Inhibitor, in Patients With Advanced Solid Tumors (NCT03057145)

Summary

To take part in this study, you must have advanced (stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using two types of targeted drugs to treat advanced breast cancer. The two drugs being used are Lynparza and prexasertib (LY2606368). Lynparza is approved by the FDA for the treatment of ovarian cancer. Laboratory studies suggest giving prexasertib with Lynparza will make Lynparza more effective. This study is also recruiting patients with other types of cancer.


This is a Phase I trial

MEDI4736 with Lynparza or Cediranib for Advanced Breast (and Other Solid) Tumors

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer (NCT02484404)

Summary

MEDI4736 (durvalumab) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation. In phase 1 of this study, researchers studied the safety and effectiveness of using MEDI4736, Lynparza or cediranib to treat advanced breast (and other solid) tumors. Phase 1 is now completed. Phase 2 of this study is open to triple-negative breast cancer patients combining MEDI4736 and olaparib. To be eligible, patients must not have previously been treated with PARP inhibitors, PD-1 or PD-L1 inhibitor or an anti-CTLA4 therapy and not have had more than 3 lines of previous treatments for metastatic disease.


This is a Phase I-II trial

Tecentriq, Perjeta and Hercptin for HER2+ Breast Cancer That Has Spread to the Brain

A Phase II Study of Atezolizumab in Combination With Pertuzumab Plus High-dose Trastuzumab for the Treatment of Central Nervous System Metastases in Patients With Her2-positive Breast Cancer(NCT03417544)

Summary

To take part in this study, you must have HER2-positive, metastatic (stage IV) breast cancer that has spread to the brain. This study is evaluating the safety and effects (good or bad) of using an immunotherapy drug along with a HER2 targeted drug to treat HER2+ metastatic breast cancer. The immunotherapy drug is atezolizumab (Tecentriq®). It is approved to treat certain types of lung and bladder cancers. It gets the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed cell death-ligand 1). The two HER2-targeted drugs used in this study are pertuzumab (Perjeta®) and trastuzumab (Herceptin®).
This is a Phase II trial

Femara, Afinitor and TRC105 Before Surgery for HR+ & HER2- Postmenopausal Women

A Phase I/II Study of Preoperative (Neoadjuvant) Combination of Letrozole (Femara), Everolimus (Afinitor), and TRC105 in Postmenopausal Women With Newly Diagnosed Local or Locally Advanced Potentially Resectable Hormone-Receptor Positive and Her2 Negative Breast Cancer (NCT02520063)

Summary

Letrozole (Femara®) is used to treat postmenopausal women with hormone-positive breast cancer. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It is used to treat advanced HR-positive, HER2-negative breast cancer. TRC105 is an experimental drug that keeps cancer cells from growing the blood vessels they need to survive. Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that the therapy has on the tumor. This study is investigating the safety and efficacy of giving Femara, Afinitor, and TRC105 before surgery to treat postmenopausal women with HR+, HER2-, stage II or III breast cancer.
This is a Phase I-II trial

Evaluating a New Targeted Therapy for HER2-Positive Advanced Breast Cancer

A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer(NCT03262935)

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 comparing the safety and effects (good or bad) of a new targeted drug to a physician's choice standard treatment for advanced HER2+ breast cancer. The new targeted therapy is called SYD985. It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The physician's standard of care drug combination will include two of the following: lapatinib (Tykerb®), capecitabine (Xeloda®), trastuzumab (Herceptin®), vinorelbine (Navelbine®), or eribulin (Halaven®).
This is a Phase III trial

Molecular Profiling-Based Targeted Therapies for Metastatic Breast (and Other) Cancer

A Basket Study: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT 2) (NCT02152254)

Summary

Molecular profiling of a tumor may identify genetic mutations or biomarkers that suggest the tumor is likely to respond to a currently available targeted therapy. It is not known if choosing metastatic breast (or other types of) cancer treatment based on the tumor's molecular profile is more effective than the current standard of care. All patients who enroll in this study will have molecular profiling performed on a biopsy of their tumor. If there is no mutation or biomarker found, the patient will receive the treatment their doctor determines is the best option. If a mutation or biomarker is found and there is an FDA-approved drug for the tumor type, patients will be offered that treatment. If there is a mutation or biomarker found but no FDA-approved drug that targets it, patients will be randomly assigned to either a targeted therapy or the standard of care.

First Study of AZD8186 in Patients

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC)... (NCT01884285)

Summary

AZD8186 is a new cancer therapy that works by inhibiting PI3K, a group of proteins that help cancer cells to grow. It is designed specifically for cancers that are characterized as being deficient in PTEN, a gene that regulates cell growth. The purpose of this study is to determine the safest, best dose of AZD8186 in PTEN-deficient cancers. This trial is enrolling individuals with triple negative breast cancer as well as other cancers.


This is a Phase I trial

Diarrhea Prevention for HER2+ Breast Cancer Patients Receiving Neratinib and Herceptin

An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early Stage HER2+ Breast Cancer Treated With Adjuvant Trastuzumab and Neratinib Followed by Neratinib Monotherapy, and Intensive Anti-diarrhea Prophylaxis (NCT03094052)

Summary

To take part in this study you must have HER2-positive, stage II or III breast cancer. You must also have already had chemotherapy and be planning to receive at least 4 months of Herceptin. This study is investigating whether taking anti-diarrhea medication can help prevent diarrhea in women and men being treated with one approved and one investigational HER2-targeted drug. The investigational HER2-targeted drug is neratinib. One of its known side effects is diarrhea. The approved HER2-targeted drug is trastuzumab (Herceptin®). Crofelemer (Mytesi®) is a medicine used to prevent diarrhea in people being treated for HIV/AIDS. Loperamide (Immodium) is an over-the-counter medication used to prevent and treat diarrhea.


This is a Phase II trial

Treating Advanced Cancer By Choosing Targeted Therapy Based on Tumor's Genetic Makeup

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study (NCT02693535)

Summary

This study is evaluating the safety and effectiveness of using the tumor's genetic alterations to select an FDA-approved targeted therapy for treatment. In this study, the targeted therapy each patient receives will be selected based on their tumor's specific genetic profile. To be eligible, individuals must have no available standard therapy options. This study is enrolling patients with advanced breast and other cancers.


This is a Phase II trial

Ribociclib and Faslodex for HR+, HER2- Advanced Breast Cancer

A Randomized Phase II Trial of Fulvestrant With or Without Ribociclib After Progression on Aromatase Inhibition Plus Cyclin-dependent Kinase 4/6 Inhibition in Patients With Unresectable or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02632045)

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. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat advanced breast cancer in postmenopausal women. This study is comparing the safety and effectiveness of Faslodex and ribocicilib to Faslodex and a placebo for treating HR+, HER2- advanced breast cancer. To be eligible, participants must have had their cancer progress after receiving an aromatase inhibitor (letrozole, exemestane, or anastrozole), and be in the process of switching their hormone therapy.
This is a Phase II trial

Xentuzumab & Abemaciclib & an Anti-Estrogen Drug for Advanced Breast Cancer

An Open Label, Phase Ib Dose-escalation Study Evaluating the Safety and Tolerability of BI 836845 and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive Breast Cancer, Followed by Expansion Cohorts (NCT03099174)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study will identify the best dose, safety and effectiveness for two new targeted drugs. The drugs will be given along with an anti-estrogen drug. The two new targeted drugs are xentuzumab (BI 836845) and abemaciclib (LY2835219). The anti-estrogen drug you are given will be letrozole (Femara®), anastrozole (Arimidex®) or fulvestrant (Faslodex®).
This is a Phase I trial

CDK-Inhibitor for Previously Treated Metastatic Disease

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer (NCT01037790)

Summary

A new target for treating metastatic breast cancer may be cyclin-dependent kinase (CDK), a family of enzymes involved in cell growth. As the name implies, CDK enzymes are only active in the presence of proteins referred to as cyclins. PD 0332991 (Palbociclib) is a new biological therapy that blocks two different cyclin-dependent kinase enzymes. This, in turn, may slow or stop a cancer's growth. The goal of this trial is to determine the side effects of Palbociclib and how well it works in treating patients with tumors that are no longer responding to standard treatment.


This is a Phase II trial

PD 0332991 & Arimidex Before Surgery for ER+, HER2- Tumors

A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer (NCT01723774)

Summary

PD 0332991 (palbociclib isethionate) is a new oral drug that works by blocking a family of enzymes that control cell division. Anastrozole (Arimidex®) is used routinely to treat hormone-sensitive tumors. Giving anti-cancer medications before surgery (neoadjuvant treatment) allows researchers to see how the tumor responds to the drugs being studied. The goal of this trial is to investigate the safety and effectiveness of giving PD 0332991 along with Arimidex before surgery to women with stage II or stage III ER+, HER2- breast cancer. To be eligible, participants must have tested negative for the PIK3CA mutations.
This is a Phase II trial

Neratinib plus a Targeted Therapy for Advanced Breast (and Other) Cancer

Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus, Palbociclib or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification, HER2 Mutation/Amplification or HER3/4 Mutation (NCT03065387)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is comparing the safety, best dose and effects (good or bad) of using a new type of targeted therapy in combination with Afinitor, Ibrance, or Mekinist to treat advanced cancers that are EGFR+, HER2+, HER3+ or HER4+. The new targeted therapy is neratinib (Nerlynx®). It is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It is approved to treat early-stage HER2+ breast cancer. Everolimus (Afinitor®) is an mTOR inhibitor. It is a targeted therapy used to treat advanced hormone-sensitive breast cancer. Palbociclib (Ibrance®) is a CDK4/6 inhibitor. It is a targeted therapy used to treat ER+, HER2- breast cancer. Trametinib (Mekinist®) is an MEK inhibitor. It is a targeted therapy used to treat some types of melanoma and lung cancer. This study is enrolling patients with other types of advanced cancer.
This is a Phase I trial

Ribociclib with Herceptin or Kadcyla for Advanced HER2-Positive Breast Cancer

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer (NCT02657343)

Summary

Ribociclib (LEE011) is a new type of targeted therapy called a CDK 4/6 inhibitor. Trastuzumab (Herceptin®) and T-DM1 (Kadcyla®) are targeted therapies routinely used to treat HER2-positive breast cancer. This study is investigating the safety and best dose of ribociclib when given in combination with Herceptin or Kadcyla to treat individuals with advanced HER2-positive breast cancer that has not responded to standard treatment.


This is a Phase I-II trial

Keytruda, Femara & Ibrance for ER+ Metastatic Breast Cancer After Femara & Ibrance

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib (NCT02778685)

Summary

To take part in this study, you must have estrogen receptor-positive (ER+), HER2-negative, metastatic breast cancer. You must have also already been treated with letrozole (Femara®) and palbociclib (Ibrance®). Femara and Ibrance are an approved breast cancer combination. Femara is an anti-estrogen drug. Ibrance is a targeted treatment. Researchers think adding an immunotherapy drug to this combination will make the combination work better in women who already tried it. The immunotherapy drug that will be used in this study is pembrolizumab (Keytruda®). Keytruda is used to treat certain types of melanoma, lung cancer and head and neck cancers. It is available as a breast cancer treatment only in clinical trials.
This is a Phase II trial

MEDI4736 & Lynparza in Metastatic HER2- Breast Cancer in Women with a BRCA Mutation

A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors (NCT02734004)

Summary

Olaparib (Lynparza) is a new type of targeted therapy called a PARP inhibitor. It works by blocking the PARP protein from repairing damaged DNA in cancer cells. Lynparza is approved for treating advanced ovarian cancer in women with a BRCA mutation. MEDI4736 is an immunotherapy that blocks PD-L1 (programmed cell death-ligand 1) protein. Blocking this protein stimulates the immune system to go after cancer cells. This study is investigating the safety and effectiveness of using Lynparaza and MEDI4736 together to treat women with HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation.


This is a Phase I-II trial

DS-8201a for HER2-Low Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] (NCT03734029)

Summary

To take part in this study you must have HER2-low advanced (some stage III) or metastatic (stage IV) breast cancer. This study is comparing the safety and effects (good or bad) of the new targeted therapy DS-8201a to the standard of care. HER2-low tumors are IHC/FISH 1+ or 2+. DS-8201a is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a topoisomerase I inhibitor directly to cancer cells.
This is a Phase III trial

Selumetinib and Lynparza for Advanced Breast (and Other) Cancer

Evaluation of the Combination of Selumetinib and Olaparib in Endometrial, Ovarian and Other Solid Tumors With Ras Pathway Alterations, and Ovarian Tumors With PARP Resistance (NCT03162627)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating whether it is safe and effective to use the drug selumetinib along with olaparib (Lynparza®) to treat advanced breast cancer. Selumetinib (AZD6244) is an experimental targeted drug called an MEK inhibitor. Olaparib (Lynparza®) is a type of targeted drug called a PARP inhibitor. It is approved to treat certain types of ovarian cancer. This study is also recruiting individuals with other types of cancer.


This is a Phase I trial

Leflunomide in Previously Treated Metastatic Triple Negative Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers (NCT03709446)

Summary

To take part in this study you must be a woman with metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer and have had no more than 2 chemotherapy drugs used to treat your metastases.

This study is investigating the safety and effects (good or bad) of leflunomide (Arava®), an oral drug that blocks dihydroorotate dehydrogenase (DHODH). It is approved to treat certain adults with rheumatoid arthritis.


This is a Phase I-II trial

INCB054828 for Advanced Breast (and Other) Cancers

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (NCT02393248)

Summary

INCB054828 is a new targeted therapy that is designed to block the FGF (fibroblast growth factor) or FGFR (fibroblast growth factor receptor) protein. Laboratory studies show that targeting the FGF or FGFR protein may be an effective way to slow or stop cancer cell growth. In this study, researchers will determine the maximum tolerated dose of INCB054828 alone and in combination with standard therapy for individuals with advanced breast (and other) solid tumors.


This is a Phase I-II trial

PRS-343 in HER2-Positive Advanced Breast Cancer

A Phase 1, Open-Label, Dose Escalation Study of PRS-343 in Patients With HER2-Positive Advanced or Metastatic Solid Tumors (NCT03330561)

Summary

To take part in this study you must have HER2-positive locally advanced (stage III) or metastatic (stage IV) breast cancer.

This study is testing the safety and effect (good or bad) of PRS-343, an experimental cancer drug. PRS-343 is a new type of cancer treatment. The drug is a HER2-targeted therapy that also stimulates the immune system. This study is also enrolling patients with other types of solid tumors.


This is a Phase I trial

Femara & Ribociclib Before Surgery in ER+, HER2- Stage II-III Postmenopausal Breast Cancer

Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer (NCT02712723)

Summary

Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is used to treat early-stage and metastatic breast cancer in postmenopausal women. Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer cells grow. Giving chemotherapy before surgery--called neoadjuvant treatment--allows researchers to study how well the tumor responds to a treatment. This study is investigating the best dose and effectiveness of ribociclib when it is used with Femara before surgery to treat stage II-III breast cancer. To be eligible, patients must be postmenopausal.


This is a Phase II trial

MLN0128 and Alisertib for Metastatic Triple-Negative Breast (and Other Advanced) Cancers

A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC) (NCT02719691)

Summary

This study is investigating whether it is safe and effective to combine two new cancer drugs. Both drugs are targeted therapies. One drug is called MLN0128. The other is called Alisertib (MLN8237). To take part in this study, you must have metastatic triple negative breast cancer and you must have already been treated with chemotherapy.

MLN0128 is a new type of targeted therapy called an mTOR inhibitor. Alisertib (MLN8237) is a new targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow. This trial is also enrolling patients with other types of cancer.
This is a Phase I trial

Ibrance, Bavencio and Faslodex for Previously Treated ER+, HER2- Advanced Breast Cancer

Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer (NCT03147287)

Summary

To take part in this study, you must have HR+, HER2-negative locally recurrent (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor in combination with an anti-estrogen therapy. This study is investigating the safety and effects (good and bad) of using fulvestrant (Faslodex®) alone, in combination with Ibrance®, and in combination with Ibrance and Bavencio®. Faslodex is the anti-estrogen drug used in this study. Palbociclib (Ibrance®) is approved to treat HR+, HER2-negative breast cancer in combination with an anti-estrogen therapy. Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat a type of blood cancer.
This is a Phase II trial

Cediranib + Lynparza for Metastatic Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT02498613)

Summary

This trial is studying the safety and effectiveness of treating metastatic breast cancer (and other solid tumors) with two drugs: Olaparib (Lynparza®) and Cediranib. To take part, you must have metastatic triple negative breast cancer and not have an inherited BRCA 1/2 mutation. Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. Cediranib is a type of drug called an angiogenesis inhibitor. Giving cediranib with Lynparza may make the Lynparza more effective.


This is a Phase II trial

177Lu-J591 to Treat Metastatic Breast (and Other Solid) Tumors

177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study (NCT00967577)

Summary

Scientists are trying to find new ways to kill cancer cells that have spread throughout the body. 177Lu-J591 is a new drug that uses radiation to kill cancer cells. To take part, you must have metastatic breast cancer, and have no other treatment options available.

177Lu-J591 combines two chemicals J591 and 177Lutetium (177Lu). J591 is a protein that attaches to a molecule found on the blood vessels of cancer cells. 177Lu is a radioactive molecule. Scientists think that it can find and kill the blood vessels that help cancer cells grow.

Faslodex & Ibrance for Women & Men Age 70 & Older with Stage I-III Breast Cancer

Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery (NCT02760030)

Summary

Some older women and men who are diagnosed with early-stage breast cancer are not able to have surgery. Two drugs now used to treat breast cancer that has spread to other parts of the body may be a good treatment option for these patients. The drugs are called fulvestrant (Faslodex®) and palbociclib (Ibrance®). To take part in this study, you must be age 70 or older, have a stage I-III, hormone receptor positive (HR+), HER2-negative breast cancer, and cannot or do not want to have surgery.

Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat metastatic HER+ tumors in postmenopausal women. Palbociclib (Ibrance®) is a type of drug called a targeted therapy. It keeps cancer cells from growing by blocking two enzymes, CDK4 and CDK6.
This is a Phase II trial

Ibrance Before Surgery for HR-Positive Stage I-III Breast Cancer

Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS): A Randomized Phase II Study of Palbociclib With Letrozole Versus Letrozole Alone for Invasive Lobular Carcinoma and Invasive Ductal Carcinoma (NCT02764541)

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two proteins, CDK4 and CDK6. Tamoxifen (Nolvadex®) and letrozole (Femara®) are hormone therapies commonly used to treat hormone sensitive breast cancer. Giving drugs before surgery is called neoadjuvant therapy. It allows researchers to study the affect the drugs have on the tumor. This study is looking at the safety and effectiveness of using the drug Ibrance along with an hormone therapy to treat breast cancer. To take part, your tumor must be hormone-sensitive and HER2-negative and at least 1.5cm in size. The drugs will be given to you before you have surgery.


This is a Phase II trial

Abemaciclib and Keytruda for HR+, HER2- Metastatic Breast (and Non-Small Cell Lung) Cancer

A Phase 2 Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02779751)

Summary

To take part in this study, you must have hormone sensitive (ER+/PR+), HER2-negative metastatic (stage IV) breast cancer. This study is investigating whether it is safe and effective to give a new type of targeted treatment along with an immunotherapy drug. The new targeted treatment is called abemaciclib (LY2835219). It is a type of targeted drug called a CDK 4/6 inhibitor. It only is available in clinical trials. Pembrolizumab (Keytruda®) is the immunotherapy drug being used in this study. Keytruda is approved to treat melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. This study is also recruiting individuals with metastatic non-small cell lung cancer.
This is a Phase I trial

Targeted and Hormone Therapies plus Ibrance for HER2+, HR+ Metastatic Breast Cancer

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer (PATINA) (NCT02947685)

Summary

To take part in this study, you must have HER2-positive, HR-positive (ER+/PR+) advanced (some stage III) or metastatic (stage IV) breast cancer. You must have already had at least 4 and at most 8 cycles of a HER2-targeted drug. This study is comparing the safety and effects (good and bad) of using a targeted drug along with the standard of care for treating HER2+, HR+ advanced breast cancer to the standard of care alone. The standard of care is a HER2-targeted drug and an anti-estrogen drug. The targeted drug being used in this study is palbociclib (Ibrance®). It is approved for treating metastatic breast cancer.
This is a Phase III trial

Keytruda® and Binimetinib for Advanced Triple Negative Breast Cancer

Phase I/II Trial of Pembrolizumab in Combination With Binimetinib in Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer(NCT03106415)

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 investigating the safety and effectiveness of using an immunotherapy along with a targeted therapy to treat triple negative breast cancer. Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It is currently approved to treat certain types of melanoma, head and neck cancer, lung cancer and Hodgkin lymphoma. Binimetinib (MEK162) is a type of targeted therapy called an MEK inhibitor.


This is a Phase I-II trial

ONC201 and Methionine-Restricted Diet in Patients With Advanced Triple Negative Breast Cancer

ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer (NCT03733119)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer and currently do not follow a vegan or vegetarian diet.

This study will compare the safety and effects (good or bad) of a targeted therapy called ONC201 in patients who are or are not on a methionine-restricted (low-protein) diet. ONC201 is an experimental targeted therapy that targets Akt/ERK and can lead to the death of a tumor cell. Methionine is an essential amino acid that is found in foods that contain protein. The researchers want to see if restricting the amount of methionine in a patient's diet affects how the cancer responds to the drug ONC201.


This is a Phase II trial

LSZ102 Alone or With Ribociclib or Alpelisib in ER+ Advanced Breast Cancer

A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy (NCT02734615)

Summary

Researchers are developing new drugs to treat hormone-sensitive metastatic breast cancer. LSZ102 is a new drug that works by destroying the estrogen receptor. In this study, researchers will determine the best dose of LSZ102 to give alone or in combination with a targeted drug. The two targeted drugs are called ribociclib and alpelisib. To take part in this study, you must have ER+ advanced or metastatic breast cancer and already have been treated with hormone therapy.
This is a Phase I trial

Anetumab Ravtansine in Advanced Triple Negative Tumors That Are Mesothelin-Positive

Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies (ARCS-Multi) (NCT03102320)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER-) that tests positive for mesothelin, a protein that some tumors overproduce.

The purpose of this study is to test the safety and effects (good or bad) of anetumab ravtansine, a targeted therapy that blocks mesothelin, a protein that helps cells stick together.


This is a Phase I trial

A New PARP Inhibitor For BRCA-Positive Advanced Breast Cancer

Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations (NCT01989546)

Summary

BMN 673 is a new type of cancer drug called a PARP inhibitor. It works by blocking the PARP--poly (ADP-ribose) polymerase--protein that helps cells repair DNA damage. Early studies suggest BMN 673 may be effective in patients with advanced breast cancer who have a BRCA mutation. This study is evaluating the effect that BMN673 has on cancer cells (through tumor biopsies) of patients with advanced breast cancer who have a known BRCA inherited mutation.


This is a Phase I-II trial

Radiation and Veliparib After Chemotherapy and Before Surgery

Pre-Operative PARPi and Irradiation (POPI) in Women With an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer (NCT01618357)

Summary

Giving chemotherapy before surgery (called neoadjuvant therapy) allows doctors to see how the tumor responds to the treatment. It can also shrink the tumor, which may permit a woman to have a lumpectomy instead of a mastectomy. About 20-30 percent of the time, the breast tumor will completely disappear, making it less likely to recur. Veliparib is a type of new cancer treatment called a PARP inhibitor. Laboratory studies have shown that it can make the tumor more likely to respond to radiation and chemotherapy. This study is investigating the safety of combining radiation and Veliparib in women with stage II or III breast cancer whose tumors do not completely disappear after neoadjuvant chemotherapy.


This is a Phase I trial

Orteronel For Androgen Receptor-Positive Metastatic Breast Cancer

A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR) (NCT01990209)

Summary

Orteronel (TAK-700) is a new type of cancer drug that works by blocking the androgen receptor (AR). It is currently in phase III trials for prostate cancer. Studies have found that about 70-90 percent of primary breast tumors and 75 percent of breast metastases are AR+. Researchers believe orteronel may be an effective treatment for individuals with metastatic breast cancer whose tumors are AR+. This study is investigating the effectiveness of orteronel in individuals with triple negative or ER+ and/or PR+ metastatic breast cancer that is AR+. The researchers will test tumor tissue from a previous biopsy to determine if a tumor is AR+.
This is a Phase II trial

Gedatolisib with Ibrance and Femara or Faslodex in ER+ HER2- Metastatic Breast Cancer

Phase 1b Study To Assess The Safety, Tolerability, And Clinical Activity Of Gedatolisib In Combination With Palbociclib And Either Letrozole Or Fulvestrant In Women With Metastatic Or Locally Advanced/Recurrent Breast Cancer (MBC) (NCT02684032)

Summary

Researchers are studying new treatment combinations for metastatic breast cancer. Palbociclib (Ibrance®) is a targeted drug that is used to treat metastatic breast cancer. It is given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®). This study is looking at the best dose of gedatolisib to add to the combination. To take part in this study, you must have ER-positive and HER2-negative metastatic breast cancer.


This is a Phase I trial

Olaparib for Metastatic Breast Cancer with an Inherited Genetic Mutation

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients With Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded) (NCT03344965)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and have an inherited DNA repair gene mutation that was identified through genetic testing of the tumor or through a blood test. This study is investigating whether olaparib (Lynparza®) is effective for treating metastatic breast cancer in women and men with a tumor that has a DNA repair gene mutation, such as BRCA1 or BRCA2. Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Lynparza is currently approved to treat recurrent ovarian cancer and HER2-negative metastatic breast cancer.


This is a Phase II trial

AZD6738 with Chemotherapy and/or Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.(NCT02264678)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, effects, and best dose of AZD6738 when it is used alone or with the chemotherapy drug carboplatin or the PARP inhibitor olaparib (Lynparza®). AZD6738 is a new type of targeted therapy called an ATR inhibitor. It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. Carboplatin is a chemotherapy drug used to treat breast cancer. Lynparza is a PARP inhibitor approved to treat BRCA+ metastatic breast cancer.
This is a Phase I-II trial

ZW49 in Patients With Advanced HER2-Positive Breast Cancer

A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers (NCT03821233)

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 evaluating the safety, side effects and best dose of a new targeted therapy called ZW49. ZW49 uses an antibody that can attach to HER2 proteins to deliver chemotherapy directly to the cancer cells. This is the first study to evaluate this drug in humans. It is also enrolling patients with other types of HER positive tumors.


This is a Phase I trial

Ifetroban for Stage II or III Breast Cancer With High Risk of Metastatic Recurrence

A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence (NCT03694249)

Summary

To take part in this study you must have completed treatment for stage II or stage III triple negative breast cancer (ER-, PR- and HER2-).

This study is investigating the safety and effects (good or bad) of using the targeted therapy ifetroban to reduce the risk of a metastatic recurrence. Ifetroban targets the thromboxane A2 receptor. Studies have found that breast cancer cells have more thromboxane A2 receptors than normal cells. Researchers think these receptors may play a role in breast cancer metastasis.


This is a Phase II trial

FATE-NK100 with Herceptin for HER2+ Advanced Breast Cancer

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (DIMENSION) (NCT03319459)

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 looking at the safety and effects (good or bad) of using an immunotherapy drug along with Herceptin to treat HER2-positive advanced breast cancer. The immunotherapy drug is called FATE-NK100. It is only available in clinical trials. Herceptin is a targeted therapy approved to treat HER2-positive breast cancer.


This is a Phase I trial

9-ING-41 Targeted Therapy With or Without Chemotherapy for Patients With Advanced Breast Cancer

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors (NCT03678883)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have no other standard treatment options available.

This study is determining the safety and the effects (good or bad) of the investigational targeted therapy 9-ING-41 when it is used with or without chemotherapy. The drug 9-ING-41 is a type of targeted therapy called a GSK-3β inhibitor. This study is also enrolling patients with other types of cancer.


This is a Phase I-II trial

GDC-9545 plus Ibrance for Locally Advanced or Metastatic ER+ Breast Cancer

A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-9545 Alone or in Combination With Palbociclib and/or LHRH Agonist in Patients With Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer (NCT03332797)

Summary

To take part in this study, you must have ER-positive, HER2-negative locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of giving GDC-9545 alone or with Ibrance to treat advanced breast cancer. GDC-9545 is the experimental drug being used in this study. Palbociclib (Ibrance®) is a type of targeted therapy that keeps cancer cells from growing by blocking two proteins, CDK 4 and CDK 6. It is approved by the FDA to treat postmenopausal women with ER+, HER2- metastatic breast cancer. Luteinizing hormone-releasing hormone (LHRH) agonist keeps the ovaries from making estrogen and progesterone.
This is a Phase I trial

Immunotherapy (PDR001) With a Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)(NCT02900664)

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 and have already had at least one prior treatment that your cancer progressed on or did not respond to. Researchers are studying the safety and effects (good or bad) of a new immunotherapy drug when it is given along with a targeted drug for treating advanced or metastatic triple negative breast cancer. If you enroll in this study will receive the immunotherapy drug PDR001. You will also receive one of four targeted drugs: Canakinumab (Ilaris®), CJM112, trametinib, or EGF816. This study is also enrolling patients with other types of cancer.


This is a Phase I trial

Faslodex and Xtandi for ER+, HER2- Metastatic Breast Cancer

Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer (NCT02953860)

Summary

To take part in this study, you must have ER-positive, HER2-negative metastatic (stage IV) breast cancer. Your tumor must also be androgen receptor positive (AR+). This tumor test will be done by the researchers. This study is investigating the the safety and effects (good and bad) of using an anti-estrogen drug and an anti-androgen drug to treat ER+, HER2- metastatic breast cancer. The anti-estrogen drug used in this study is fulvestrant (Faslodex®). It is approved to treat postmenopausal women with metastatic breast cancer. The anti-androgen drug is enzalutamide (Xtandi®). It is approved to treat prostate cancer. If you are premenopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

CAR-T Immunotherapy for Stage IV Breast Cancer That Has Spread to the Pleura

A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin (NCT02414269)

Summary

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

This study is investigating the safety and effect (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The pleura is the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. This CAR-T therapy is designed to target proteins found on cancer cells in the pleura. The CAR-T therapy is given along with acetaminophen and diphenhydramine. These drugs are used to prevent infusion-related reactions.


This is a Phase I trial

Palbociclib With Fulvestrant for ER+, HER2- Advanced Breast Cancer

Phase II Trial of Palbociclib With Fulvestrant in Individuals With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Who Have Progressed on Treatment With Palbociclib and an Aromatase Inhibitor (NCT02738866)

Summary

To take part in this study you must have ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with palbociclib (Ibrance®) and an aromatase inhibitor.

This trial is investigating the safety and effects (good and bad) of using Ibrance and Faslodex to treat women and men with advanced breast cancer who have previously been treated with Ibrance and an aromatase inhibitor. Ibrance is a CDK4/6 inhibitor approved to treat HR positive, HER2 negative breast cancer in combination with an anti-estrogen therapy. Faslodex is an anti-estrogen therapy approved to treat postmenopausal women with metastatic breast cancer.


This is a Phase II trial

T-DM1 (Kadcyla) in Early-Stage HER2 Positive Breast Cancer

ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT03587740)

Summary

To take part in this study you must have HER2 positive stage I, II or III breast cancer.

This study is testing the safety and effectiveness of using T-DM1 (Kadcyla®) to treat early-stage HER2 positive breast cancer. T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells. Kadclya is approved to treat HER2-positive metastatic breast cancer.


This is a Phase II trial

A166 for HER2 Positive and HER2 Low Expression Advanced Breast Cancer

A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies (NCT03602079)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies.

This study is evaluating the safety and effects (good and bad) of the experimental therapy A166 in women and men with advanced breast cancer. A166 is an antibody-drug conjugate (ADC). It combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I-II trial

Arimidex, Ibrance, Herceptin and Perjeta for HR+, HER2+ Metastatic Breast Cancer

A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HeR-positive, Her2-positive Metastatic Breast Cancer (NCT03304080)

Summary

To take part in this study, you must have HR+ (ER+/PR+), HER2+ metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using two anti-estrogen targeted therapies and two HER2-targeted therapies to treat HR+, HER2+ metastatic breast cancer. The anti-estrogen therapies being used in this study are palbociclib (Ibrance®) and anastrozole (Arimidex®). The HER2-targeted therapies are trastuzumab (Herceptin®) and pertuzumab (Perjeta®). All four therapies are approved to treat metastatic breast cancer.
This is a Phase I-II trial

AVID100 in Advanced Epithelial Carcinomas

Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin (NCT03094169)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options and tests positive for EGFR over-expression.

This study is to determine the safety and effects (good or bad) of using an experimental targeted therapy called AVID100. AVID100 is a targeted antibody-drug conjugate (ADC). It targets EGFR proteins to deliver a chemotherapy drug called maytansinoid mertansine (DM1). This study is also enrolling patients with other types of tumors that test EGFR positive.


This is a Phase I-II trial

BMS-986158 for Advanced Triple Negative Breast (and Other) Cancer

A Basket Study: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Advanced Solid Tumors (NCT02419417)

Summary

To take part in this study, you must have advanced (some stage III) and stage IV triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether a new targeted drug for triple negative breast cancer is safe and effective. The new drug being studied is called BMS-986158. It is currently only available in clinical trials. This study also is enrolling patients with other types of advanced cancers.


This is a Phase I-II trial

CX-2009 for Advanced Breast (and Other) Cancer

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009) (NCT03149549)

Summary

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

This study in investigating the safety and effects (good and bad) of a new immunotherapy for treating advanced breast cancer. CX-2009 A166 is an antibody-drug conjugate (ADC). It combines chemotherapy with targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. This trial is also enrolling patients with other types of solid tumors.


This is a Phase I-II trial

PF-06804103 in HER2+ Advanced Breast Cancer

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS (NCT03284723)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) HER2+ breast cancer and have no standard treatment options available. This study is investigating the safety and effect (good or bad) of PF-06804103. This investigational therapy is an antibody drug conjugate (ADC). It uses a HER2-targeted agent to deliver the chemotherapy drug Auristatin-0101 directly to HER2+ cancer cells. This study is also enrolling patients with other types of HER2+ solid tumors.
This is a Phase I trial

Dinaciclib With Paclitaxel for Advanced Breast Cancer

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.


This is a Phase I trial

Neratinib for HER2-Positive Brain Metastases

A Phase II Trial of HKI-272 (Neratinib) for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases (NCT01494662)

Summary

Brain metastases are difficult to treat because many drugs are unable to cross the blood-brain barrier, which means they cannot enter the brain from the bloodstream. The experimental drug Neratinib (HKI-272) is a tyrosine kinase inhibitor. It works by blocking the HER2 and EGFR receptors, both of which are involved in cancer cell growth. Neratinib is a much smaller molecule than Herceptin® (the drug widely used to treat HER2+ tumors), and it is able to cross the blood-brain barrier. The goal of this trial is to determine how well neratinib works in treating breast cancer that has spread to the brain, as well as the effect that it has on cognitive functioning.
This is a Phase II trial

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer (NCT01969643)

Summary

Antibody-drug conjugate (ADC) is a cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells. Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects. SGN-LIV1A is an ADC that targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and delivers a cancer drug called monomethyl auristatin E. This study will assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in women with HER2-negative metastatic breast cancer. To be eligible, participants must have triple negative metastatic breast cancer or HER2-negative, hormone sensitive metastatic breast cancer that can no longer be treated with a hormone therapy.


This is a Phase I trial

PF-06873600 for Metastatic HER2-Negative Breast Cancer

Phase 1/2a Dose Escalation And Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics And Anti-tumor Activity Of Pf-06873600 As A Single Agent And In Combination With Endocrine Therapy (NCT03519178)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive, HER2 negative breast cancer and have already been treated with a CDK 4/6 inhibitor.

This study is evaluating the safety and effects (good or bad) of PF-06873600, a new targeted therapy. PF-06873600 is a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting the CDK enzymes that help cancer cells grow. Patients in the study with hormone-receptor positive breast cancer will also be treated with an anti-estrogen therapy.


This is a Phase II trial

Two Targeted Therapies with Tocilizumab for HER2+ Metastatic Breast Cancer Resistant to Herceptin

A Phase 1 Multi-Center Trial of Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab (NCT03135171)

Summary

To take part in this study, you must have HER2-positive metastatic (stage IV) breast cancer and you must have already been treated with Herceptin. This study is investigating the safety and effects (good and bad) of using three targeted drugs to treat HER2-positive metastatic breast cancer that has stopped responding to Herceptin. The three drug combination will use two HER2-targeted drugs—Herceptin and pertuzumab (Perjeta®)— along with tocilizumab (Actemra®). Laboratory studies suggest Actemra, a targeted drug approved to treat rheumatoid arthritis, may get HER2+ tumors to start responding again to Herceptin.
This is a Phase I trial

Veliparib and/or Tecentriq for BRCA+, Stage III-IV Triple Negative Breast Cancer

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) (NCT02849496)

Summary

To take part in this study, you must have stage III or IV triple negative (ER-/PR-/HER2-) breast cancer. You must also test positive for the inherited BRCA1/2 mutation. This study is investigating how well two different types of cancer drugs work when they are used alone or together to treat stage III or IV triple negative breast cancer. The two drugs being used in this study are Veliparib (ABT-888) and atezolizumab (Tecentriq). Veliparib (ABT-888) is a new type of targeted drug called a PARP inhibitor. It is available only in clinical trials. Tecentriq is a new immunotherapy drug. It is approved to treat bladder cancer and a type of lung cancer.


This is a Phase II trial

GDC-0077 & Hormone Therapy with or without Ibrance for Advanced Breast Cancer

A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant... (NCT03006172)

Summary

To take part in this study, you must have advanced breast cancer (metastatic/stage IV and some stage III) that has a PIK3CA mutation. (Your tumor will be tested for a PIK3CA mutation to see if you are eligible.) This study is investigating the safety and effect of a new drug called GDC-0077 when it is used to treat advanced breast cancer that has a PIK3CA mutation. If your tumor is hormone-sensitive (ER+ and/or PR+) and HER2-negative you will receive GDC-0077 with a targeted drug and/or an anti-estrogen drug. Palbociclib (Ibrance®) is the targeted drug being used in this study. Letrozole (Femara®) and fulvestrant (Faslodex®) are the anti-estrogen drugs. All are approved breast cancer treatments.
This is a Phase I trial

A Cancer Vaccine and Pembrolizumab for Advanced HER2 Positive Breast Cancer

A Phase II Randomized Study to Evaluate the Immunologic and Antitumor Activity of Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Advanced HER2-overexpressing Breast Cancer (NCT03632941)

Summary

To take part in this study you must have recurrent or advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer.

This study is to comparing the safety and effects (good or bad) of using the investigational tumor vaccine VRP-HER2 alone, to pembrolizumab (Keytruda®) alone, and to both treatments together. The VRP-HER2 cancer vaccine is designed to activate the immune system to go after HER2 positive cancer cells. Keytruda is a type of immunotherapy called a PDL-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase II trial

Oral TTI-101 in Patients with Advanced Breast Cancer

Phase I Study of TTI-101, an Oral Inhibitor of Signal Transducer and Activator of Transcription (STAT) 3, in Patients With Advanced Cancers (NCT03195699)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer and no standard treatment options available.

This study is evaluating the safety, effects (good or bad), and best dose of TT1-101, a new oral cancer drug. TTI-101 is a tyrosine-kinase inhibitor that blocks STAT3, a protein that helps cancer cells grow. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I trial

Ibrance with Femara and Herceptin Before Surgery for Stage II-III ER+ HER2+ Breast Cancer

A Phase II Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab as Neoadjuvant Treatment of Stage II-III ER+ HER2+ Breast Cancer (PALTAN) (NCT02907918)

Summary

To take part in this study, you must have been diagnosed with ER-positive, HER2-positive stage II-III breast cancer and not yet started treatment. This study is investigating the effect that a combination therapy used to treat HER2-negative breast cancer has on ER+, HER2+ breast cancer cells when it is given along with a HER2-targeted drug. The effect of the treatment will be studied by giving the therapy before surgery. This is called neoadjuvant treatment. The three drugs that will be used in this study are the targeted drug palbocicilib (Ibrance®), which is used along with an anti-estrogen drug to treat metastatic ER+, HER2- breast cancer; the anti-estrogen drug letrozole (Femara®); and the HER2-targeted drug trastuzumab (Herceptin®). If you are premenopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

Lynparza Alone or With a New Drug That Targets DNA Repair in Metastatic TNBC

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant... (VIOLETTE) (NCT03330847)

Summary

To take part in this study you must have metastatic triple negative breast cancer that has been treated with up to two other drug therapies. Also, your tumor must have a mutation in genes that are part of the homologous recombination repair (HRR) pathway, which includes BRCA 1/2. Your tumor will be tested for mutations in these genes as part of the screening process. This study will compare the safety and effects (good and bad) of using olaparib (Lynparza®) alone to using Lynparza along with a new drug that targets DNA repair. Lynparza is a type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. The experimental drugs used in this study, AZD6738 and AZD1775, also target DNA damage repair.


This is a Phase II trial

  • Participation Time5 initial visits, then 1 visit every 2 months for 18 months, then 1 visit every 3 months
  • Participating research sites
    Research sites: 20 sites total

ARX788 for HER2 Positive Advanced Breast Cancer

A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression (NCT03255070)

Summary

To take part in this study you must have HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies and has already been treated with trastuzumab (Herceptin®).

This study is evaluating the safety, effects (good or bad) and best dose of ARX788. ARX788 is an antibody-drug conjugate (ADC). It uses an antibody that targets HER2 positive cancer cells to deliver a chemotherapy drug called amberstatin269 directly to these cells. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I trial

Tucatinib, Ibrance plus Femara in Advanced HR+, HER2+ Breast Cancer

Phase IB/II Open-label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination With Palbociclib and Letrozole in Subjects With Hormone Receptor Positive and HER2-positive Metastatic Breast Cancer (NCT03054363)

Summary

To take part in this study, you must have hormone receptor-positive (ER+ and/or PR+), HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This must be your first or second treatment for your advanced cancer. This study is investigating the safety and effects (good or bad) of using two targeted therapies along with a hormone therapy to treat advanced HR+, HER2+ breast cancer. The two targeted therapies being used in this study are tucatinib (ONT-380) and palbociclib (Ibrance®). Tucatinib is a tyrosine kinase inhibitor that targets HER2. Ibrance targets the CDK 4/6 protein and is approved by the FDA to treat postmenopausal women with ER+, HER2+ metastatic breast cancer. The hormone therapy used in this study is letrozole (Femara®). Premenopausal women who enroll in this study will also receive a drug to stop ovarian function.
This is a Phase I-II trial

Opdivo plus Cometriq for Metastatic Triple Negative Breast Cancer

A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer(NCT03316586)

Summary

To take part in this study, you must be a woman with triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy and a targeted therapy to treat triple negative metastatic breast cancer. Nivolumab (Opdivo®) is the immunotherapy used in this study. It is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. Cabozantinib (Cometriq®) is the targeted therapy that helps block the growth of the blood vessels tumors need to thrive. It is used to treat certain types of metastatic thyroid cancer.


This is a Phase II trial

Neratinib & Imodium after Herceptin for HER2+ Stage I-III Breast Cancer

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide (NCT02400476)

Summary

Neratinib is a targeted therapy that is currently being studied in clinical trials for HER2-positive breast cancer. These studies have found that diarrhea is one of the common side effects of neratinib. Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea. This study is investigating whether women with HER2+ tumors who take Imodium along with neratinib experience less diarrhea. To be eligible, participants must have previously received trastuzumab (Herceptin®).
This is a Phase II trial

AZD9833 With or Without Palbociclib in ER Positive and HER2 Negative Advanced Breast Cancer

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib in Women With ER Positive, HER2 Negative Advanced Breast Cancer(NCT03616587)

Summary

To take part in this study, you must have ER positive and HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies and, if metastatic, has not been treated with more than two different chemotherapy regimens.

This study will evaluate the safety and effect (good or bad) of AZD9833 alone or in combination with palbociclib (Ibrance®). AZD9833 is an experimental drug that targets the estrogen receptor and is being developed to treat ER positive, HER2 negative breast cancer. Ibrance is a targeted drug used to treat metastatic breast cancer. If you are premenopausal, you will also receive a drug that will put you in temporary menopause.


This is a Phase I trial

Targeted Therapy Recommendation Based on Genomic Profiling

A Basket Study: Registry Study for Personalized Cancer Therapy (NCT02508662)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have already received a treatment that your cancer progressed on or did not respond to. If you take part in this study, researchers will review your medical records to learn about your tumor's genomic profile. This information will be used to recommend a targeted drug that is FDA-approved for patients who don't have breast cancer but do have tumors with the same genomic profile. This study is also recruiting patients with other types of advanced cancer.

Seribantumab Plus Faslodex for Postmenopausal Women With HR+ Advanced Breast Cancer

SHERBOC: A Double-blind, Placebo-controlled, Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (NCT03241810)

Summary

To take part in this study, you must be postmenopausal and have advanced (stage III) or metastatic (stage IV) breast cancer. You must have had no more than two prior therapies, one of which was a CDK inhibitor. This study is comparing the safety and effects (good and bad) of giving an anti-estrogen drug along with a new targeted therapy to giving an anti-estrogen drug along with a placebo in postmenopausal women with advanced breast cancer. The anti-estrogen drug being used in this study is fulvestrant (Faslodex®). It is commonly used to treat advanced breast cancer. The targeted therapy being used in this study is called seribantumab (MM-121).


This is a Phase II trial

LY2606368 For Metastatic Triple Negative or BRCA1/2-Associated Breast Cancer

A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in Women With BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Non-High Risk Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer at Low Genetic Risk. (NCT02203513)

Summary

LY2606368 is a new type of cancer drug called a Chk1/2 (checkpoint kinases 1/2) inhibitor. By blocking the activity of Chk1/2, LY2606368 may slow or stop cancer cell growth. Early studies suggest LY2606368 may be an effective treatment for certain types of breast tumors. This study is looking at whether LY2606368 can shrink tumors in patients with metastatic breast cancer who carry a BRCA1/2 mutation or who have a triple-negative (ER-, PR-, HER2-) tumor. To be eligible for this study, patients must have already tried standard treatments.


This is a Phase II trial

Immunotherapy LY3300054 Alone and in Combination in Advanced Breast Cancer

A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT) (NCT02791334)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative or tests positive for high microsatellite instability (MSI-H). You must also have had at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.

This study is testing the safety and effects (good or bad) of LY3300054 when it is used alone or in combination with a targeted therapy or an immunotherapy. LY3300054 is a type of immunotherapy called a checkpoint inhibitor. There are three other drugs being used in this study. LY3321367 is also an investigational checkpoint inhibitor. Ramucirumab (Cyramza) is a targeted therapy that blocks VEGFR-2, which keeps tumors from forming new blood vessels. It is approved to treat certain types of solid tumors, but not breast cancer. Abemaciclib (Verzenio) is a CDK 4/6 inhibitor approved to treat HR positive and HER2-negative metastatic breast cancer.


This is a Phase I trial

Radiation Therapy With or Without Olaparib For Inflammatory Breast Cancer

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer (SWOG 1706) (NCT03598257)

Summary

To take part in this study you must be a woman with stage III inflammatory breast cancer.

This study is comparing the benefits and the effects (good and bad) of using radiation therapy along with a PARP inhibitor to radiation therapy alone. The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with a BRCA genetic mutation. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.


This is a Phase II trial

A Study of CDX-1140 as Monotherapy or in Combination in Pati...

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies (NCT03329950)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer and have no other standard treatment options available.

This study is testing the safety, effects (good or bad) and best dose of the experimental cancer drug CDX-1140 when it is used alone or in combination with CDX-301, which is also an experimental cancer drug. CDX-1140 targets a protein called CD40, which is found on cancer cells. CDX-301 is a new type of tyrosine-kinase inhibitor. It is also a targeted therapy. This study is enrolling patients with other types of solid tumors.


This is a Phase I trial

Zejula Before Surgery for HER2-Negative BRCA+ Breast Cancer

An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients (NCT03329937)

Summary

To take part in this study, you must have HER2-negative early stage (stage I-III) breast cancer, have tested positive for a BRCA1 or BRCA2 mutation. This study is investigating the safety and effects (good and bad) of a targeted therapy for HER2-negative breast cancer. In this study, the drug is given before surgery. This is called neoadjuvant treatment. Giving the drug before surgery allows doctors to study the effect the treatment has on the tumor. The targeted therapy is niraparib (Zejula®). It is a PARP inhibitor. These drugs work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. It is approved to treat women with certain types of reproductive cancers whose tumors responded to a platinum-based chemotherapy. Its use in breast cancer is considered experimental.


This is a Phase I trial

Tecentriq & Cotellic or Idasanutlin for ER+, HER2- Advanced Breast Cancer

BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer (NCT03566485)

Summary

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

This study is investigating the safety and effects (good or bad) of giving an immunotherapy along with a targeted therapy. The immunotherapy used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. The two targeted therapies being used in this study are cobimetinib (Cotellic®), an MEK-targeted therapy approved to treat melanoma, and idasanutlin, a targeted therapy being studied in clinical trials.


This is a Phase I-II trial

PD-0332991 & T-DM1 in Advanced HER2+ Tumors with the Rb Protein

Phase 1B Study of PD-0332991 in Combination With T-DM1 in the Treatment of Patients With Advanced HER2 (Human Epidermal Growth Factor Receptor 2)-Positive Breast Cancer (NCT01976169)

Summary

Researchers are looking for new ways to treat HER2+ breast cancer that has stopped responding to trastuzumab (Herceptin®) or other HER2-targeted therapies. PD-0332991 (Palbociclib) is a new targeted therapy that works by blocking two enzymes, CDK4 and CDK6, that play a role in cell growth. Studies suggest that palbociclib may be effective in tumors that test positive for a tumor suppressor protein called retinoblastoma (Rb). Scientists estimate that between 20% and 35% of breast cancers test positive for the Rb protein. T-DM1 (Kadcyla®) is a HER2-targeted therapy that combines the chemotherapy drug DM1 with trastuzumab. This study will identify the best dose of palbociclib to use along with T-DM1 to treat HER2-positive recurrent or metastatic breast cancer. To be eligible, participants must have a tumor that tests positive for the Rb protein.
This is a Phase I trial

Tamoxifen, Palbociclib, Avelumab Before Surgery in ER Positive Breast Cancer

A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Tamoxifen: The ImmunoADAPT Study (NCT03573648)

Summary

To take part in this study you must have stage II or stage III ER-positive breast cancer that will be treated with surgery.

This study is investigating whether giving tamoxifen and avelumab before surgery shrinks tumors more than the combination of tamoxifen, avelumab and palbociclib. Tamoxifen (Nolvadex®) is a hormonal therapy used to treat ER-positive breast cancer. Avelumab (Bavencio®) is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat non-small-cell lung cancer. Its use in breast cancer is considered experimental. Palbociclib (Ibrance®) is a CDK inhibitor. It is approved to treat ER-positive, HER2-negative metastatic breast cancer. Giving therapies before surgery, called neoadjuvant treatment, allows researchers to measure how tumors respond to different therapies.


This is a Phase II trial

PEN-866 for Triple Negative Advanced Breast (and Other) Cancer

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies (NCT03221400)

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 trial is investigating the safety and effects (good or bad) of a new type of targeted therapy called PEN-866. This study is also enrolling patients with other types of advanced cancer. This trial is the first study to test this drug in cancer patients.


This is a Phase I-II trial

Alisertib plus Fulvestrant for Advanced ER+, HER2- Breast Cancer

Randomized Phase II Trial to Evaluate Alisertib Alone or Combined With Fulvestrant for Women With Advanced, Endocrine-Resistant Breast Cancer (NCT02860000)

Summary

To take part in this study, you must be postmenopausal and have ER-positive, HER2-negative locally advanced (some stage III) or metastatic (stage IV) breast cancer. You must not have been treated with an aurora kinase inhibitor. This study is comparing the safety and effect of the targeted drug alisertib alone to the combination of alisertib and fulvestrant (Faslodex®) in postmenopausal women with locally advanced or metastatic breast cancer. Alisertib is an experimental targeted drug that blocks aurora A kinase. Faslodex is an anti-estrogen drug used to treat hormone-sensitive metastatic breast cancer in postmenopausal women.


This is a Phase II trial

Radiation Therapy, Palbociclib & Hormone Therapy for Breast Cancer Related Bone Metastases

A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients (NCT03691493)

Summary

To take part in this study you must have estrogen receptor positive, HER2 negative metastatic (stage IV) breast cancer that has spread to the bone.

This study will investigate the effects (good or bad) of using radiation therapy along with the targeted therapy palbociclib (Ibrance®) and hormone therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Ibrance is a type of targeted therapy called a CDK 4/6 inhibitor. It is used along with a hormone therapy to treat metastatic breast cancer. The hormone therapies used along with Ibrance are fulvestrant (Faslodex®), letrozole (Femara®), anastrozole (Arimidex®), exemestane (Aromasin®) and tamoxifen.


This is a Phase II trial

Gedatolisib, Ibrance and Faslodex Before Surgery in Women With ER+ HER2- Breast Cancer

Phase I Dose-Escalation Study of Combination of Gedatolisib (a Dual Inhibitor of PI3-K and mTOR) With Palbociclib and Faslodex in the Neoadjuvant Setting in Previously Untreated Patients With ER+/HER2- Breast Cancer (NCT02626507)

Summary

To take part in this study you must be a woman with ER-positive HER2-negative stage I, II, III or IV (metastatic) breast cancer who has not yet had any breast cancer treatments and is scheduled to have a lumpectomy or a mastectomy.

The purpose of this study is to test the safety and effects (good or bad) and best dose of the targeted therapy gedatolisib when used along with fulvestrant (Faslodex®) and palbociclib (Ibrance®). The combination is given before surgery. This is called neoadjuvant treatment. Giving therapy before surgery allows researchers to study the effect the therapy has on the breast tumor. Gedatolisib kills cancer cells by blocking the PI3K/mTOR pathway. Faslodex® is a hormone therapy approved to treat advanced breast cancer in postmenopausal women. Ibrance® is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved to treat metastatic breast cancer. If you are premenopausal, you will also be given the drug goserelin (Zoladex®), which will put you in temporary menopause.


This is a Phase I trial

DS-8201a Plus Immunotherapy for HER2 Positive or HER2 Low Expression Advanced Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer (NCT03523572)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies.

This study will test the safety and effects (good or bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer. DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

T-DM1 and Palbociclib for Advanced HER2 Positive Breast Cancer

A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer (NCT03530696)

Summary

To take part in this study you must have metastatic (stage IV) HER2-positive breast cancer.

This study is comparing the side effects and effectiveness of the combination of T-DM1 (Kadcyla®) and palbociclib (Ibrance®) to T-DM1 (Kadcyla®) alone. Kadcyla® is a HER2-targeted therapy that combines the chemotherapy drug DM1 with the HER2 targeted therapy trastuzumab (Herceptin). It is approved for patients with previously treated HER2-positive metastatic breast cancer. Ibrance® is a CDK4/6 inhibitor approved to treat metastatic breast cancer when given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®).


This is a Phase II trial

AZD5363 for ER+ Advanced Breast (and Other) Tumors with an AKT Mutation

A Pilot Study of AZD5363 for Patients With Advanced Solid Tumors Harboring Mutations in AKT1, AKT2, or AKT3 (NCT03310541)

Summary

To take part in this study, you must have been diagnosed with ER-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. You must also be postmenopausal, have already been treated with fulvestrant (Faslodex®) and have your tumor test positive for a specific AKT mutation. This study is investigating the safety and best dose of a new targeted therapy when it is given along with Faslodex to treat patients with advanced ER+ breast cancer that has a specific AKT mutation.The new targeted therapy, called AZD5363, works by blocking the AKT1 protein, which plays a role in cancer cell growth. Fulvestrant (Faslodex®) is an anti-estrogen drug used to treat advanced breast cancer. This study is also recruiting women and men with other types of cancer.
This is a Phase I trial

Neratinib plus Faslodex for HER2+, ER+ Advanced Breast Cancer

A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer (NCT03289039)

Summary

To take part in this study, you must have ER-positive, HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using a newly approved targeted therapy along with a hormone therapy to treat advanced breast cancer. The newly approved targeted therapy is neratinib (Nerlynx®). It is a tyrosine kinase inhibitor that is approved to treat early-stage HER2+ breast cancer. Fulvestrant (Faslodex®) is a hormone therapy approved to treat hormone sensitive metastatic breast cancer in postmenopausal women.
This is a Phase II trial

Genetic Tumor Profiling to Select Targeted Drug to Treat Advanced Breast Cancer

A Basket Study: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute (NCT03098576)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have had at least one treatment your tumor did not respond to or progressed on. In this study, a sample of your tumor will be analyzed (called molecular profiling) at Cedars-Sinai Medical Center in California to determine which targeted drug could be used as a treatment for your cancer. Molecular profiling is a process that identifies mutations and biomarkers in your tumor's DNA that have FDA-approved matched therapies or are eligible for clinical studies.

SAR439859 with Ibrance in Postmenopausal Women with ER+, HER2- Advanced Breast Cancer

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer(NCT03284957)

Summary

To take part in this study, you must have ER-positive, HER2-negative, locally advanced (some stage III) or metastatic (stage IV) breast cancer. You must also be postmenopausal and have already received treatment for your breast cancer. This study will determine the best dose, safety and effects (good or bad) of SAR439859 when it is given alone or in combination with palbociclib (Ibrance®). SAR439859 is an experimental anti-estrogen drug. It is available only in clinical trials. Ibrance® is a targeted therapy that blocks the CDK4/6 protein. It is approved to treat postmenopausal women with ER+, HER2- metastatic breast cancer.
This is a Phase I-II trial

MCS110 and PDR001 For Advanced Triple Negative Breast (and Other) Cancer

A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies (NCT02807844)

Summary

To take part in this study, you must have advanced triple negative breast cancer and have already been treated with standard treatments or have no standard treatment available. This study is investigating whether it is safe and effective to combine two cancer drugs that work in different ways. The researchers also want to learn more about how these two drugs work together. The two drugs being used in this study are MCS110 and PDR001. MCS110 is a targeted treatment. PDR001 is an immunotherapy drug. Both of these drugs are currently only available in clinical trials. This study is also enrolling patients with advanced pancreatic and endometrial cancers and advanced melanoma (skin cancer).


This is a Phase I-II trial

GZ17-6.02 for Metastatic Breast Cancer (GEN602)

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Given Orally on a Daily x 28 Day Schedule in Patients With Advanced Solid Tumors or Lymphoma (NCT03775525)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer and have no other available standard treatment options.

This study is investigating the safety and effect (good or bad) of a new type of cancer drug called GZ17-6.02. Researchers have found that the drug blocks the super-enhancers that send signals for cells to grow. This study is also enrolling women with advanced endometrial cancer.


This is a Phase I trial