Home   /  Find a Trial  /  See All Trials HELP  /   AYUDA  /   求助 : help-desk@bctrials.org  /   (415) 476-5777 Click to print page  Print

see All Trials

Sort by zip code:  

 

Share

Facebook
Twitter

 
Targeted therapy

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

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

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

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

A New Targeted Therapy 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

TAK228 plus Paraplatin and Taxol for Advanced Breast Cancer

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

Summary

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


This is a Phase I trial

Alimta and Nexavar for Recurrent or Metastatic Triple Negative Breast Cancer

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

Summary

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


This is a Phase 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

Ricolinostat and Abraxane for Advanced Breast Cancer

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

Summary

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


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

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

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

PU-H71 with Abraxane for HER2- Metastatic Breast Cancer

A Phase 1b Study of PU-H71 With Nab-paclitaxel (Abraxane) in Patients With HER2-Negative Metastatic Breast Cancer (NCT03166085)

Summary

To take part in this study, you must have HER2-negative metastatic breast cancer. All patients must have already had at least one line of chemotherapy for metastatic breast cancer. If you have ER+ breast cancer, you must have had at least one anti-estrogen drug or have a tumor that did not respond to anti-estrogen therapy. This study is investigating the safety and effects (good and bad) of using a targeted drug along with chemotherapy to treat HER2-negative metastatic breast cancer. The targeted drug is called PU-H7. It is an HSP90 inhibitor. The chemotherapy drug being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat metastatic breast cancer.
This is a Phase I 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

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

Immunotherapy and Halaven for HER2 Negative Metastatic Breast Cancer

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

Summary

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

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


This is a Phase I 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

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

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

ARQ092 with Carboplatin and Paclitaxel in Advanced Breast Cancer

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

Summary

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


This is a Phase I-II trial

MM-310 for Metastatic Triple Negative Breast (and Other) 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

Hormone Therapy With or Without Ibrance for HR+, HER2- Stage II-III Breast Cancer

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer (PALLAS) (NCT02513394)

Summary

Palbociclib (Ibrance®) was approved in February 2015 for treating metastatic breast cancer. Now, researchers want to determine if it will be an effective treatment for early-stage breast cancer. This study, called PALLAS, is investigating whether using Ibrance along with a hormone therapy after surgery is more effective than hormone therapy alone for reducing recurrence in patients with hormone-sensitive, HER2-negative stage II or stage III breast cancer. To be eligible, participants must be planning to start hormone therapy or have already started hormone therapy (within the last 6 months).


This is a Phase III 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

Margetuximab or Trastuzumab with Chemotherapy for HER2+ Advanced Breast Cancer

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment (SOPHIA) (NCT02492711)

Summary

Trastuzumab (Herceptin®) is a targeted therapy routinely used to treat HER2-positive breast cancer. MAGH22 (Margetuximab) is a new HER2-targeted therapy. This study is comparing the effectiveness of Margetuximab and chemotherapy to Herceptin and chemotherapy in patients with HER2-positive advanced breast cancer. The patient's physician will choose the chemotherapy regimen.


This is a Phase III trial

Ninlaro and Faslodex for Advanced ER+, HER2- Breast Cancer

Phase I Study of the Combination of MLN9708 and Fulvestrant in Patients With Advanced Estrogen Receptor Positive Breast Cancer (NCT02384746)

Summary

Ixazomib (Ninlaro®) is a type of targeted therapy called a proteasome inhibitor. It is approved for treatment of multiple myeloma. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women whose tumors have progressed on other types of hormone therapy. Laboratory studies suggest Ninlaro can kill breast cancer cells that have been treated with Faslodex. This study is investigating the best dose, safety and efficacy of Ninlaro when it is given in combination with Faslodex for treating metastatic ER+/HER2- breast cancer.
This is a Phase I trial

Procaspase Activating Compound-1 for Metastatic Breast (and other) Cancer

(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies (NCT02355535)

Summary

Procaspase Activating Compound-1 (PAC-1) is a small molecule designed to kill cancer cells by converting the enzyme procaspase-3 to caspase-3. Laboratory studies suggest PAC-1 may be effective in breast and other types of cancer. This study is investigating the safety and effect of PAC-1 in patients with metastatic breast (and other) cancer that has stopped responding to standard therapies.


This is a Phase I 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

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

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

Two Targeted Therapies for Advanced Triple Negative Breast Cancer

A Phase 1b Trial of LY2606368 in Combination With Chemotherapy or Targeted Agents in Advanced and/or Metastatic Tumors (NCT02124148)

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 effects (good and bad) of using two new targeted therapies together. One of the drugs being used in this study is prexasertib (LY2606368). It works by targeting the CHK1/2 protein. The other targeted drug is called LY3023414. It is an oral PI3K/mTOR dual inhibitor. This study is also recruiting patients with other types of advanced cancer.


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. 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

CUDC-907 in Advanced Breast Cancer (And Other Solid Tumors)

Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors (NCT02307240)

Summary

Researchers are trying to develop new drugs that can be used to treat hormone sensitive (ER+/PR+) tumors that have stopped responding to the currently available hormone therapies. CUDC-907 is a targeted therapy that works by blocking HDAC and PI3K, two enzymes that play an important role in cell growth. This study will determine the best dose, safety and efficacy of CUDC-907 for treating women with advanced breast cancer. To be eligible, a woman must have HER2-negative breast cancer that has been treated with at least one hormonal therapy in the advanced/metastatic setting or that recurred during adjuvant (after surgery) therapy. This trial is also enrolling patients with other types of solid tumors.
This is a Phase I trial

Study of PF-06647020 for Advanced Triple Negative Breast Cancer and Other Solid Tumors

A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors (NCT02222922)

Summary

PF-06647020 is a type of targeted therapy called an antibody-drug conjugate. These drugs combine a targeted therapy with chemotherapy in order to deliver the chemotherapy directly to the cancer cells. This study is investigating the safety and best dose of PF-06647020 for treating advanced triple-negative breast cancer (and other solid tumors).


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.

AZD5363 for Metastatic Breast (and Other) Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies. (NCT01226316)

Summary

AZD5363 is a new type of targeted therapy called an AKT protein kinase inhibitor. It works by blocking the AKT1 protein, which plays a role in cancer cell growth. This study is investigating the best dose, safety, and tolerability of AZD5363 in patients with ER+, HER2+ metastatic breast cancer. To be eligible, individuals must have a tumor that has an AKT1 mutation or a PIK3CA mutation and have no available standard therapies.This study is also recruiting individuals with other types of advanced solid tumors.
This is a Phase I 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

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

Dasatinib Before Surgery for Women with Triple-Negative Breast Cancer

Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (NCT02720185)

Summary

To take part in this study, you must be diagnosed with triple-negative breast cancer that can be removed by surgery. You must also have a tumor that is tested and found to be nuclear EGFR-positive. Giving treatment before surgery (called neoadjuvant treatment) allows researchers to study the effect the drug has on your cancer cells. If you enroll in this study, you will receive the drug dasatinib (Sprycel®) before receiving the standard of care treatment for triple-negative breast cancer. Sprycel is used to treat a type of leukemia. It is not yet known if it will also be an effective treatment for 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

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 (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 trastuzumab (Herceptin®) and a taxane-based chemotherapy. This study will compare the safety and effects (good or bad) of two different HER2-targeted therapies, DS-8201a and T-DM1. DS-8201a (Trastuzumab deruxtecan) is an experimental HER2-targeted therapy. T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.


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

Tucatinib with Xeloda & Herceptin to Treat Advanced HER2+ Breast Cancer

Pivotal Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) (NCT02614794)

Summary

Tucatinib (formerly ONT-380 or ARRY-380) is an investigational HER2-targeted therapy. Tucatinib is a small molecule that early studies suggest may be able to pass through the blood-brain barrier. This could make it an effective treatment for HER2+ breast cancer that has spread (metastasized) to the brain. Trastuzumab (Herceptin®) is a HER2-targeted therapy routinely used to treat HER2-positive breast cancer. Capacitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer. This study is comparing the safety and effectiveness of tucatinib vs placebo, each in combination with Herceptin and Xeloda for patients with advanced HER2-positive breast cancer that has progressed on prior therapy.
This is a Phase 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

Ibrance & Hormone Therapy in Patients with Advanced Breast Cancer

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers (NCT02384239)

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. Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is a hormone therapy used in postmenopausal women to treat hormone-sensitive breast cancer that has stopped responding to other hormone therapies. This study is comparing the effectiveness of two different doses of Ibrance -- 100 mg or 125 mg -- when it is given with Faslodex or tamoxifen (physician's choice) to treat patients with advanced breast cancer who have already been treated with an mTOR or PI3K inhibitor.


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

Poziotinib for HER2-Positive Metastatic Breast Cancer

A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC (NCT02659514)

Summary

Pozitinib is a new targeted therapy that works by blocking the EGFR receptor and the HER2 receptor. Early studies suggest pozitinib may be effective in HER2-positive tumors. This study is evaluating the efficacy and tolerability of poziotinib for treating HER2-positive metastatic breast cancer. To be eligible, participants must have received at least two prior HER2-targeted therapies.


This is a Phase 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 available only in clinical trials. 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

Genomic Profiling to Recommend Treatment for Metastatic Breast (and other solid) Tumors

A Basket study: Tumor Genomic Profiling: A Personalized Medicine Approach (NCT02215928)

Summary

Genomic profiling of a tumor provides information about the specific genetic changes or abnormalities that are helping the cancer grow. Using this information may help doctors determine which treatments will be most effective. In this study, researchers will use genomic profiling to recommend treatments for patients with metastatic breast (and other solid) tumors. This will help them evaluate whether choosing treatment based on genomic profiling is more effective than using the standard treatment. To be eligible, participants must be be receiving breast cancer care at the Stanford Cancer Institute in California.

  • Participation TimeVisits every 6-8 weeks
  • Participating research sites
    Research sites: 0 sites total

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 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.


This is a Phase II trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 0 sites total

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

Testing a Tumor with Specific Genetic Abnormality for Advanced Disease

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.

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

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

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

ABBV-075 for Advanced Breast (and Other) Cancers

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer (NCT02391480)

Summary

ABBV-075 is new targeted therapy designed to block the bromodomain (BRD)-containing protein. Laboratory studies suggest blocking this protein can slow or stop cancer cell growth. This study will determine the maximum tolerated dose of ABBV-075 in women and men with advanced breast (and other) solid tumors. To be eligible, a patient must have progressed on standard therapy or not have a standard therapy available.


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

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

XMT-1522 for Advanced Breast (and Other) Cancer

A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1522 in Patients With Advanced Breast Cancer and Other Advanced Tumors Expressing HER2 (NCT02952729)

Summary

To take part in this study, you must have certain types of stage III or stage IV (metastatic) breast cancer. This study will determine the safety of a new cancer drug, the best dose of the drug to use, and the effectiveness of the best dose. The experimental drug being used in this study is called XMT-1522. It only is available in clinical trials. This study is also enrolling individuals with non-small cell lung cancer and gastric cancer.


This is a Phase I 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.

Ibrance for Metastatic HER2+ or Triple-Negative Breast Cancer That Has Spread to the Brain

A Phase II Single Arm Study of Palbociclib in Patients With Metastatic HER2-Positive and Triple Negative Breast Cancer With Brain Metastasis (NCT02774681)

Summary

Researchers think the drug palbociclib (Ibrance®) can help treat breast cancer that has spread to the brain. To take part in this study, you must have triple negative or HER2-negative breast cancer that has spread to the brain; you cannot already have been treated with Ibrance; and you cannot have any type of chemotherapy within 2 weeks of starting Ibrance.

Breast cancer that has spread to the brain is difficult to treat because most cancer drugs cannot get through the blood-brain barrier. Ibrance is a new type of drug that keeps cancer cells from growing by blocking two enzymes called CDK4 and CDK6. It is used to treat breast cancer that has spread to other parts of the body.
This is a Phase II trial

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

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

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

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

Ibrance and Femara in African-American Women with Advanced HR+ HER2- Breast Cancer

Phase II Safety Study of Palbociclib in Combination With Letrozole in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer (NCT02692755)

Summary

Researchers want to learn more about the safety and effectiveness of breast cancer treatments in African-American women. In this study, women will receive two drugs, palbociclib (Ibrance®) and letrozole (Femara®). The researchers will study the drug's effectiveness. They will also study whether this drug combination increases your risk of developing an infection by lowering your number of white blood cells. This condition is called neutropenia. Ibrance is a targeted therapy that blocks two different enzymes. Femara is a hormone therapy used to treat postmenopausal women with advanced breast cancer. To take part in this study, you must identify as Black, African or African-American and have hormone-sensitive, HER2-negative advanced breast cancer. And, you must not have already been treated with a CDK 4/6 inhibiting therapy.


This is a Phase II-III 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

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

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

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

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

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

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 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

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

Poziotinib with Kadcyla for HER2+ Breast Cancer

A Phase 1b Study of Poziotinib in Combination With T-DM1 in Women With Advanced or Metastatic HER2-Positive Breast Cancer (NCT03429101)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. In this study, researchers will investigate the safety, best dose, and effects (good or bad) of using a new targeted therapy along with the targeted drug T-DM1(Kadcyla®) to treat HER2-positive advanced breast cancer. Poziotinib is the investigational targeted therapy used in this study. It works by blocking the EGFR receptor and the HER2 receptor on cancer cells. Kadcyla is used to treat HER2-positive breast cancer. It combines the chemotherapy drug DM1 with trastuzumab (Herceptin®).


This is a Phase I trial

Ribociclib and Bicalutamide for Advanced AR+ Triple Negative Breast Cancer

A Phase I/II, Single Arm, Non-randomized Study of Ribociclib (LEE011), a CDK 4/6 Inhibitor, in Combination With Bicalutamide, an Androgen Receptor (AR) Inhibitor, in Advanced AR+ Triple-negative Breast Cancer: Big Ten Cancer Research Consortium BRE15-024 (NCT03090165)

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. Your tumor must also be androgen receptor positive (AR+). This study will identify the best dose of ribociclib to use along with an anti-androgen drug. Ribociclib (LEE011) is a type of targeted drug called a CDK (cyclin-dependent kinase) inhibitor. Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer.
This is a Phase I-II 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 works by stopping cancer cells from dividing. 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

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 conjugates (ADCs) are cancer therapies that combine 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

Neratinib for Advanced HER2-Positive Breast Cancer in Women and Men Age 60 and Older

Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer (NCT02673398)

Summary

To take part in this study, you must be age 60 or older and have locally advanced (stage III) or metastatic (stage IV) HER2-positive breast cancer. You must also not have previously been treated with neratinib (Nerlynx®). This study is looking at how well neratinib works in patients age 60 and older with HER2-positive advanced or metastatic breast cancer. Neratinib is a type of anti-cancer drug called a tyrosine kinase inhibitor. It is only available in clinical trials.


This is a Phase II trial

Jakafi and Herceptin for Metastatic HER2-Positive Breast Cancer

Phase I/II Trial of Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer (NCT02066532)

Summary

Researchers are trying to determine the best way to treat HER2+ metastatic breast cancer. Ruxolitinib (Jakafi®) is used to treat myelofibrosis, a disease of the bone marrow. Laboratory studies suggest it may also be an effective cancer treatment. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. This study is looking at the safety and efficacy of giving Jakafi along with Herceptin to treat patients with HER2+ metastatic breast cancer.
This is a Phase I-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

Olaparib (Lynparza®) for BRCA+, HER2- Metastatic Breast Cancer

A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations (LUCY) (NCT03286842)

Summary

To take part in this study, you must have HER2-negative metastatic (stage IV) breast cancer and have been tested for and found to have a BRCA1 or BRCA2 genetic mutation. This study is investigating the effectiveness of using the targeted therapy Olaparib (Lynparza®) to treat BRCA+, HER2- metastatic breast cancer. Lynparza® is a type of targeted therapy called a PARP inhibitor. It is FDA approved for the treatment of BRCA+, HER2- breast cancer. This study is being conducted to see the effectiveness of Lynparza when it is used as approved in multiple locations in the real world.
This is a Phase III 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 include BRCA 1/2. You 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: 11 sites total

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

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

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

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

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

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

TAS0728 for Metastatic Breast Cancer that is HER2-positive or has HER2 or HER3 Mutations

A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities (NCT03410927)

Summary

To take part in this study, you must have stage IV metastatic breast cancer that is HER2-positive or has HER2 or HER3 mutations. You must also have received a treatment that your tumor progressed on or did not respond to. This study is evaluating the safety, tolerability, pharmacodynamics and efficacy of an experimental targeted therapy called TAS0728 for treating metastatic breast cancer that is HER2-positive or has HER2 or HER3 mutations. TAS0728 is a new type of HER2 targeted therapy that works by binding to HER2.


This is a Phase I-II trial

Triciribine & Paclitaxel in Strage 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

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

LEE011, BYL719 & Femara for Advanced ER+/HER2- Breast Cancer

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer (NCT01872260)

Summary

Researchers are looking for new targeted therapies and new drug combinations that will be effective breast cancer treatments. LEE011 and BYL719 are two new targeted therapies that may slow or stop breast cancer growth. LEE011 works by blocking two enzymes, called CDK4 and CDK6, that are needed for cell growth. BYL719 works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is an anti-estrogen drug that is routinely used to treat hormone-sensitive tumors. Previous studies have shown that combining a targeted therapy with an anti-estrogen drug may prevent breast cancer cells from developing resistance to hormone therapy. This study is comparing the safety and effectiveness of using LEE011 and BYL719 alone or in combination with Femara to treat ER+/HER2- locally advanced or metastatic breast cancer.
This is a Phase I 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

Kadcyla and Perjeta Before Surgery in Stage II & III HER2-Positive Breast Cancer

The Impact of HER2 Heterogeneity on the Treatment of Early-stage HER2-positive Breast Cancer: a Phase II Study of T-DM1 in Combination With Pertuzumab in the Preoperative Setting (NCT02326974)

Summary

T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). This allows the chemotherapy drug to be delivered directly to the cancer cells. Pertuzumab (Perjeta®) is approved to treat patients with advanced HER2+ breast cancer. It is also approved as a neoadjuvant (before surgery) treatment for patients with HER2+ early-stage breast cancer who are at high risk for recurrence. Giving chemotherapy before surgery (neoadjuvant treatment) allows researchers to study the effect that a treatment has on the breast tumor. This study is evaluating the safety and effectiveness of giving Kadcyla along with Perjeta before surgery to patients with HER2+ stage II or stage III breast cancer.
This is a Phase II trial

Kadcyla and Neratinib for Metastatic HER2-Positive Breast Cancer

A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer (NCT02236000)

Summary

Trastuzumab emtansine (T-DM1/Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). This allows the DM1 to be delivered directly to the cancer cells. It is approved for the treatment of HER2+ metastatic breast cancer in patients who have already received Herceptin and a taxane. Neratinib is a new drug currently being studied for HER2-targeted breast cancer. It works by blocking two receptors, HER2 and EGFR. This study is looking at the safety, best dose, and efficacy of neratinib that can be given with Kadcylato treat HER2-positive metastatic breast cancer that has progressed on prior anti-HER2 based therapy. To be eligible, patients must have had one (and only one) regimen of anti-HER2 based therapy for metastatic disease (dual anti-HER agents may have been given in combination e.g., docetaxel, trastuzumab and pertuzumab).
This is a Phase I-II trial

LY3023414 for Advanced Breast (and other) Cancers

A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer (NCT01655225)

Summary

LY3023414 is an experimental drug that researchers believe has the potential to be effective against breast and other cancers. The purpose of this first-in-human study is to identify a safe recommended dose level and schedule of dosing for LY3023414. The study will also explore what affect LY3023414 has on certain biological markers (biomarkers) associated with tumor growth, as well as on the cancer cells. To be eligible, participants must have already tried, or not be able to take, other available standard therapies. (This trial is also enrolling individuals with advanced lymphoma and mesothelioma, and possibly other cancers as well.)


This is a Phase I 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

SC-005 for Advanced Triple Negative Breast Cancer

An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC) (NCT03316794)

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 no other standard treatment options. This study is investigating the safety and effects (good or bad) of using the drug called SC-005 to treat advanced triple negative breast cancer. SC-005 is an experimental therapy only available in clinical trials.


This is a Phase I trial

Xgeva for HR+ HER2- Metastatic Breast Cancer That Has Spread to the Bone

A Phase II, Open Label Study to Evaluate Denosumab in Patients With ER and/or PR-Positive, HER2-Negative Metastatic Breast Cancer (MBC) With Bone Metastases and Detectable Circulating Tumor Cells (CTCs) (NCT03070002)

Summary

To take part in this study, you must have ER+ and/or PR+, HER2-negative metastatic breast cancer that has spread to the bone. You can be on any breast cancer treatment. You must have a blood test that shows you have circulating tumor cells (CTCs). This study is looking at whether denosumab (Xgeva®) lowers the number of CTCs found in patients with metastatic breast cancer that has spread to the bone. CTCs are cancer cells that are moving through your body in your blood. They can form new tumors in other parts of your body. Xgeva is used to treat patients whose cancer has spread to the bone. It can help prevent fractures, spinal cord compression, and the need for bone radiation or surgery.
This is a Phase II trial

Fulvestrant and Venetoclax for ER+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy (NCT03584009)

Summary

To take part in this study you must be a woman with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who has already been treated with a CDK 4/6 inhibitor.

This study is comparing the effects of fulvestrant (Faslodex) and ventoclax to fulvestrant alone in women with advanced estrogen receptor positive, HER2 negative breast cancer who have already been treated with a CDK 4/6 inhibitor. Faslodex is an anti-estrogen therapy used to treat advanced breast cancer. Venetoclax (Venclexta) is targeted therapy approved to treat certain types of blood cancers.


This is a Phase II trial

DS-8201a Versus Standard of Care for HER2 Positive Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T DM1 (NCT03523585)

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. 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

Romidepsin for Patients with Breast Cancer & Liver Dysfunction

A Phase 1 and Pharmacokinetic Single Agent Study of Romidepsin in Patients With, Lymphomas, Chronic Lymphocytic Leukemia and Select Solid Tumors and Varying Degrees of Liver Dysfunction (NCT01638533)

Summary

Targeted therapies are being developed that may be effective against many different types of tumors, including breast cancer. Romidepsin (Istodax®) is an HDAC inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that are important for the cancer's growth and survival. Romidepsin was approved in November 2009 for the treatment of cutaneous T-cell lymphoma. Since then, researchers have conducted studies to see if it might also be effective in patients with other types of cancer. This study is evaluating the safety of different dose levels of romidepsin in cancer patients with varying degrees of abnormal liver function. To be eligible, patients must have breast cancer (or lymphoma, chronic lymphocytic leukemia, or other certain solid tumors for which standard treatment is no longer effective) and be experiencing liver dysfunction.


This is a Phase I trial

GSK525762 plus Faslodex for ER+ Advanced Breast Cancer

A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With ER+ Breast Cancer (NCT02964507)

Summary

To take part in this study, you must have ER+ advanced (some stage III) or metastatic (stage IV) breast cancer. GSK525762 is a newly developed drug that researchers think may be effective for treating ER+ advanced breast cancer. This study will determine whether it is safe to treat breast cancer with GSK525762. It will also identify the best dose of GSK525762 to use when it is given with fulvestrant (Faslodex®), an anti-estrogen drug commonly used to treat advanced breast cancer.
This is a Phase II trial

Bevacizumab & Temsirolimus with Valproic Acid or Cetuximab in Advanced Breast Cancer

A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination With Valproic Acid, or Cetuximab in Patients With Advanced Malignancy and Other Indications(NCT01552434)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have previously been treated with a standard therapy.

This study will compare the effects (good and bad) of bevacizumab (Avastin®) and temsirolimus (Torisel®) alone or with valproic acid (Depakote®) or cetuximab (Erbitux®) in women and men with advanced or metastatic breast cancer. Avastin is a targeted therapy that blocks the growth of the blood vessels that cancer cells need to survive. It is used to treat metastatic breast cancer. Torisel is a type of targeted therapy called an mTOR inhibitor. It is approved to treat kidney cancer. Depakote is an anti-seizure medication that researchers think may also slow cancer cell growth. Erbitux is a type of targeted therapy called an EGFR inhibitor. It is approved to treat head, neck and colorectal cancer.


This is a Phase I trial

Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer (NCT02926690)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study will determine the safety and effects (good and bad) of using an experimental drug called OTS167PO to treat advanced and metastatic breast cancer. OTS167PO is a type of new treatment called a MELK inhibitor.


This is a Phase I trial

Alpelisib plus Endocrine Therapy for HR+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment (NCT03056755)

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. Your tumor must also test positive for a PIK3CA mutation. In addition, you must already have been treated with a CDK4/6 inhibitor. This study is investigating the safety and effects (good and bad) of giving the targeted drug alpelisib along with an anti-estrogen drug to women with HR+, HER2- advanced breast cancer already treated with a CDK4/6 inhibitor. Alpelisib (BYL719) is a PI3K inhibitor. Fulvestrant (Faslodex®) or letrozole (Femara®) are the anti-estrogen drugs used in this study. The anti-estrogen drug you receive will be based on the anti-estrogen drug you received when on the CDK4/6 inhibitor.
This is a Phase II trial

Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.


This is a Phase II trial

Abemaciclib in Advanced Triple Negative Breast Cancer with the Rb Protein

A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer (NCT03130439)

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. You must also have a tumor that tests positive for the retinoblastoma (Rb) protein. The researchers will test your tumor for this protein. This study will evaluate the safety and effects (good and bad) of an experimental drug called abemacicilb when it is used to treat triple negative breast cancer that tests positive for the Rb protein. The experimental drug is called abemaciclib (LY2835219). It is a type of targeted drug called a CDK4/6 inhibitor. Studies have found that the Rb protein, which can help stop tumors from growing, doesn't work properly in certain cancers.


This is a Phase II trial

Ibrance and Tamoxifen for HR+, HER2- Advanced Breast Cancer

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016 (NCT02668666)

Summary

To take part in this study, you must have hormone receptor-positive (ER+/PR+), recurrent stage III or stage IV metastatic breast cancer. You must also have recently received this diagnosis and not yet had any treatment for it. This study is investigating how well a targeted drug along with an anti-estrogen drug work as a first-line treatment for metastatic breast cancer or stage III recurrent breast cancer. The targeted drug being used in this study is palbociclib (Ibrance®). The anti-estrogen drug is tamoxifen (Nolvadex®).
This is a Phase II trial

Sacituzumab Govitecan for Previously Treated Advanced Triple Negative Breast Cancer

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT) (NCT02574455)

Summary

To take part in this study, you must have been diagnosed with triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer that stopped responding to at least two different chemotherapy regimens. This study is comparing the effects (good and bad) of a new targeted therapy for advanced triple negative breast cancer to a standard of care treatment selected by the patient's oncologist. The targeted therapy is sacituzumab govitecan (IMMU-132). It uses an antibody that can target the protein TROP-2 to help bring the chemotherapy irinotecan (Camptosar®) directly into the cancer cells.


This is a Phase III trial

Personalized Gene-Based Treatment For Triple Negative Breast Cancer

A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 (NCT02101385)

Summary

Researchers are trying to determine the best treatment for triple negative breast cancer. DNA from tumor samples collected at the time of surgery may provide information about which breast cancer treatments will work best on a specific tumor. Participants will have their tumors analyzed for 12 biomarkers or pathways found in breast cancer cells. One group will receive treatment based on the results. The other women will receive the standard of care. This will allow the researchers to compare therapy designed for each individual's tumor to the standard of care. To be eligible, participants must have had (or are planning to have) chemotherapy followed by surgery for breast cancer.


This is a Phase II trial

Supinoxin™ for Metastatic Triple Negative Breast Cancer

A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors (NCT02003092)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. This study will help determine the safety and effects (good and bad) of an investigational targeted drug in metastatic triple negative breast cancer. The targeted drug used in this study is RX-5902 (Supinoxin™). It is an oral drug. You must not eat for 8 hours before taking the drug, and you must not eat for at least 3 hours after taking it.


This is a Phase I-II trial

SY-1365 for Advanced Breast (and Other) Cancer

A Basket Study: A Phase 1 Study of SY-1365, a Selective CDK7 Inhibitor, in Adult Patients With Advanced Solid Tumors (NCT03134638)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must have also already had a treatment that your cancer progressed on or did not respond to. This study will help researchers learn the safety and effects (good and bad) of a new targeted drug when it is used to treat advanced or metastatic breast cancer. SY-1365 is the targeted drug used in this study. It is a selective CDK7 inhibitor. This study is also enrolling patients with other types of cancers.


This is a Phase I trial

Neratinib For HER2-Negative Metastatic Breast Cancer

A Phase II Study of Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Summary

About 25 percent of individuals with breast cancer have tumors that have a genetic mutation that causes the cancer cells to have too many copies of the HER2 gene and too many HER2 receptors. These tumors are called HER2-positive, and they can be treated with the anti-HER2 targeted therapies Herceptin and Tykerb. Scientists recently discovered that some HER2-negative tumors have other types of HER2 genetic mutations that might make them respond to anti-HER2 targeted therapies. Neratinib is a new targeted therapy being developed to treat HER2-positive tumors. Researchers think it may also be effective in individuals whose tumors are HER2-negative but have these newly discovered HER2 mutations. The purpose of this study is to evaluate Neratinib in participants with metastatic breast cancer whose tumors are HER2-negative but have these HER2 mutations. Participants who meet the entry criteria for this study will have their tumor tested for HER2 mutations. Only those who are found to have a HER2 mutation will be able to take part in the study.


This is a Phase II trial

Ibrance and Hormone Therapy for Adults Age 70 & Older with ER+, HER2- Metastatic Breast Cancer

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer (NCT03633331)

Summary

To take part in this study, you must be 70 or older and have ER positive HER2 negative metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of giving the targeted therapy palbociclib (Ibrance®) along with a hormone therapy in women and men age 70 or older. Ibrance is approved to treat metastatic breast cancer in combination with a type of hormone therapy called an aromatase inhibitor. The two aromatase inhibitors being used in this trial are letrozole (Femara®) and fulvestrant (Faslodex®).


This is a Phase 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

Debio 1347 plus Faslodex for HR+ Metastatic Breast Cancer

A Phase Ib/II Study of Debio 1347 Plus Fulvestrant in Patients With FGFR-Amplified Endocrine Receptor Positive Metastatic Breast Cancer (NCT03344536)

Summary

To take part in this study, you must have HR-positive metastatic (stage IV) breast cancer, and your tumor must test positive for FGFR (fibroblast growth factor receptor). This study is investigating the safety and effects (good and bad) of using an experimental targeted therapy called Debio 1347 along with Faslodex to treat HR+ metastatic breast cancer. Debio 1347 works by targeting the FGFR protein. Fulvestrant (Faslodex®) is a hormone therapy used to treat hormone-sensitive metastatic breast cancer. If you are premenopausal, you will also be treated with goserelin (Zoladex®).
This is a Phase I-II trial

Olaparib After Chemo for BRCA+ HER2-Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative... (OlympiA trial) (NCT02032823)

Summary

Olaparib (Lynparza) is a new 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. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage HER2-negative breast cancer.


This is a Phase III trial

LY2835219 and Hormone Therapy for Metastatic Breast Cancer

A Phase 1b Study of LY2835219 in Combination With Endocrine Therapies for Patients With Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (NCT02057133)

Summary

Researchers have developed a new type of targeted therapy called a CDK 4/6 inhibitor. LY2835219 is one of the CDK 4/6 inhibitors now being studied. Laboratory studies suggest that LY2835219 may be an effective treatment for hormone-sensitive metastatic breast cancer. This study is evaluating the safety of using LY2835219 along with standard hormone therapy—Letrozole (Femara®), Anastrozole (Arimidex®), Tamoxifen, Exemestane (Aromasin®), or Exemestane (Aromasin®) and Everolimus (Afinitor®)—to treat women with hormone sensitive, HER2-negative metastatic breast cancer.


This is a Phase I trial

Ibrutinib and Herceptin in HER2+ Advanced Breast Cancer

Phase I/II Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer (NCT03379428)

Summary

To take part in this study, you must have been diagnosed with advanced (stage III) or metastatic (stage IV) HER2+ breast cancer. This study is investigating the safety and effects (good or bad) of using an experimental therapy along with trastuzumab (Herceptin®) to treat advanced or metastatic HER2+ breast cancer. Ibrutinib (Imbruvica) is the experimental targeted therapy being used in this study. It is currently approved for treating certain types of blood cancers. Herceptin is a targeted therapy used to treat HER2-positive breast cancer.
This is a Phase I-II trial

Afinitor, Femara and Herceptin for Metastatic ER+, HER2+ Tumors

Combination Treatment With Everolimus, Letrozole and Trastuzumab in Hormone Receptor and HER2/Neu-positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors: Evaluating Synergy and Overcoming Resistance (NCT02152943)

Summary

Researchers are studying new drug combinations for treating metastatic breast cancer. Letrozole (Femara®) is an aromatase inhibitor used to treat ER+ tumors. Everolimus (Afinitor®) is an mTOR inhibitor. It is used along with exemestane (Aromasin®) to treat postmenopausal women with advanced ER+, HER2- breast cancer. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This study will identify the highest dose of Femara that can be given along with Afinitor and Herceptin to postmenopausal women with metastatic ER+, HER2+ tumors and evaluate the safety of the drug combination. This study is also enrolling patients with other types of cancers.
This is a Phase I 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

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

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

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

Keytruda with INCB039110 or INBC050465 for Advanced Breast (and Other Solid) Tumors

A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors (NCT02646748)

Summary

Pembrolizumab (Keytruda®) targets a protein called programmed cell death-1 (PD-1). Blocking this protein gets the immune system to kill cancer cells. NCB039110 and INCB050465 are two new experimental targeted therapies. INCB039110 works