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AC Chemo Followed by Taxol with or without Paraplatin for Triple-Negative Breast Cancer

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

Summary

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


This is a Phase III trial

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

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

Summary

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


This is a Phase I-II trial

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

Keytruda plus Taxol for Metastatic HER2-Negative Breast Cancer

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

Summary

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


This is a Phase II trial

A Study of a New Drug (NKTR-102) in Breast Cancer Patients with Stable Brain Metastases

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

Summary

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


This is a Phase III 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

Xtandi and Taxol Before Surgery for Stage I-III Triple-Negative Breast Cancer

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

Summary

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

Halaven & Cytoxan for Advanced Breast Cancer

A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies (NCT01554371)

Summary

Combining two or more cancer drugs that work in different ways may be more effective than using one cancer drug at a time. Eribulin (Halaven®) is approved for treating metastatic breast cancer. Cyclophosphamide (Cytoxan®) is approved for treating many different types of cancer, including breast cancer. However, the combination of eribulin and cyclophosphamide is considered experimental. The purpose of this study is to test the safety and effectiveness of the two drugs when they are given together at different doses to patients with locally advanced or metastatic breast cancer (and other solid tumors).


This is a Phase I-II trial

MEDI4736 and Chemotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

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

Summary

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


This is a Phase I-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

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

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (EA1131) (NCT02445391)

Summary

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


This is a Phase III trial

Keytruda + Chemo or an Aromatase Inhibitor for HER2-Negative Metastatic Breast Cancer

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

Summary

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


This is a Phase II 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

Paraplatin and Taxotere Before Surgery for Stage I-III Triple-Negative Breast Cancer

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

Summary

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


This is a Phase II trial

Eribulin and AC Before Surgery for HER2-Negative Inflammatory Breast Cancer

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

Summary

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


This is a Phase II 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

Comparing Two Different Doses of Xeloda for Metastatic Breast (and GI) Cancer

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

Summary

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


This is a Phase II trial

Vaccine Therapy and Chemotherapy for Treating Triple Negative Breast Cancer

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

Summary

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


This is a Phase II trial

Atezolizumab & Abraxane for Triple Negative Stage I-III Breast Tumors

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

Summary

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


This is a Phase II trial

Dose-Dense ACT Chemo without Neulasta for Early Stage Breast Cancer

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

Summary

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


This is a Phase II trial

Abraxane & Mifepristone in Advanced Triple Neg Breast Cancer with Glucocorticoid Receptors

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

Summary

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


This is a Phase II trial

INT230-6 Injections & Immunotherapy for Treating Advanced Breast Cancer

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

Summary

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


This is a Phase I-II trial

Radiation & Chemotherapy Together or Sequentially for Early-Stage, ER- Breast Cancer

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

Summary

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


This is a Phase I-II trial

Keytruda and Abraxane in HER2-Negative Metastatic Breast Cancer

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

Summary

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

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

Tecentriq and Paclitaxel for Triple Negative Advanced Breast Cancer

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

Summary

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


This is a Phase III 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

Keytruda & Decitabine Followed by Chemo Before Surgery for Locally Advanced HER2- Disease

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

Summary

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


This is a Phase II trial

Carboplatin plus Nivolumab in Advanced Triple Negative Breast Cancer

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

Summary

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


This is a Phase II trial

Predicting Response to Cisplatin & Radiation in Advanced Triple Negative Breast Cancer

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

Summary

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


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

Imlygic™ plus Chemo Before Surgery for Stage II-III Triple Negative Breast Cancer

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

Summary

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


This is a Phase I-II trial

Tecentriq with Chemotherapy After Surgery for Stage II-III Triple-Negative Breast Cancer

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

Summary

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


This is a Phase III trial

Tesetaxel and Capecitabine or Capecitabine Alone For HER2-, HR+ Advanced Breast Cancer

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

Summary

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

Treatment and Tissue Collection Before Surgery in Patients With Stage II-III Breast Cancer

Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy (NCT01897441)

Summary

Giving treatment before surgery—called neoadjuvant therapy—allows researchers to study the effect that the cancer drugs have on the breast tumor. Collecting and storing samples of tissue from breast cancer patients for laboratory research may help scientists learn which tumors respond best to certain treatments. This trial is collecting and storing tissue from patients with stage II-III breast cancer who have been given one of three different treatment combinations prior to surgery.

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

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

Summary

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


This is a Phase II 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

Taxol Before Surgery for Stage I-III Breast Cancer

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response (NCT03096418)

Summary

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

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

Monitoring Tumor Response During Neoadjuvant (Before Surgery) Chemotherapy

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

Summary

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


This is a Phase I trial

BTP-114 for Patients with a BRCA 1/2 Mutation and Advanced Triple Negative Breast Cancer

Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation (NCT02950064)

Summary

To take part in this study, you must have advanced (some stage III and stage IV), triple-negative (ER-/PR-/HER2-) breast cancer and have been told you have inherited a BRCA1/2 mutation. You must also have had at most three other types of chemotherapy treatments. This study is investigating whether a new type of targeted chemotherapy drug is safe and effective when used to treat advanced triple negative breast cancer in women and men who have an inherited BRCA1 or BRCA2 mutation. The new chemotherapy drug is called BTP-114. This study is also recruiting women and men with other types of cancer.


This is a Phase I trial

Opdivo plus Xeloda After Surgery for Triple Negative Breast Cancer

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

Summary

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

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


This is a Phase II 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

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

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

Summary

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

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


This is a Phase II 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

Atezolizumab & Chemotherapy Before Surgery for Stage II-III Triple Negative Breast Cancer

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer (NCT03197935)

Summary

To take part in this study, you must have been diagnosed with triple negative (ER-/PR-/HER2-) early stage (stage I-III) breast cancer and not yet started treatment. This study is comparing the safety and effects (good and bad) of using immunotherapy and chemotherapy to chemotherapy alone in triple negative breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It stimulates the body's immune system to go after cancer cells. The chemotherapy drugs being used in this study are nab-paclitaxel (Abraxane®) and AC chemotherapy (doxorubicin/Adriamycin® and cyclophosphamide/Cytoxan®). All three drugs are commonly used to treat breast cancer. Patients enrolled in this study will also receive filgrastim or pegfilgrastim to prevent neutropenia--a very low white blood cell count--from developing.


This is a Phase III 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

Taxotere and Paraplatin Before Surgery in ER-, HER2- Stage II-III Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery (NCT02124902)

Summary

Researchers are trying to determine the best treatments for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. This study is looking at the effect that Taxotere and Paraplatin have on cancer cells when they are given before surgery to treat patients with stage II or stage III triple-negative breast cancer.


This is a Phase II trial

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

Chemotherapy before Surgery with Atezolizumab for Triple Negative Breast Cancer

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

Summary

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


This is a Phase III trial

Immunotherapy Before Surgery for HR+, HER2- Stage II-III Breast Cancer

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

Summary

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

Carboplatin plus Atezolizumab for Metastatic Triple Negative Breast Cancer

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

Summary

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


This is a Phase II trial

Atezolizumab plus Chemotherapy for Early Relapsing Recurrent Triple Negative Breast Cancer

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

Summary

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


This is a Phase III trial

Dietary Intervention plus Chemotherapy Before Surgery for Early Stage Breast Cancer

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

Summary

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

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

Cisplatin vs. AC Before Surgery in Patients w/ a BRCA Mutation

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

Summary

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

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

Keytruda plus Abraxane Before Surgery for ER+ or PR+ Stage II or III Breast Cancer

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

Summary

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

Halaven plus Keytruda for HR+ Metastatic Breast Cancer

A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer (NCT03051659)

Summary

To take part in this study, you must have HR+ metastatic (stage IV) breast cancer. This study is evaluating the safety and effectiveness of combining a chemotherapy drug with an immunotherapy drug. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of melanoma, lung, head and neck cancers, and blood cancers. The chemotherapy drug being used in this study is eribulin mesylate (Halaven®). It is approved for treating metastatic breast cancer.
This is a Phase 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

Abraxane® and Paraplatin® Before Surgery for Stage II & III Triple Negative Tumors

Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer (NCT01525966)

Summary

Chemotherapy drugs work by either killing cancer cells or by stopping them from dividing. Giving chemotherapy before surgery (called neoadjuvant therapy) may make the tumor smaller and reduce the amount of tissue that needs to be removed. Researchers can also study a drug's effectiveness by assessing how much the tumor shrinks in response to the treatment. Abraxane® (nab-paclitaxel) and Paraplatin® (carboplatin) are chemotherapy drugs that are approved for the treatment of advanced breast cancers. The goal of this study is to determine how well these two chemotherapy drugs work when they are given together before surgery to treat women with locally advanced or inflammatory triple negative (ER-/PR-/HER2-) breast cancer.


This is a Phase II trial

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

Keytruda plus Two Chemotherapy Drugs for Metastatic Triple-Negative Breast Cancer

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

Summary

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


This is a Phase II trial

MRI Before Breast Conserving Surgery for Newly Diagnosed Early-Stage Breast Cancer

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

Summary

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

A Study Comparing Active Surveillance to Treatment for Low-Risk DCIS

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

Summary

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

Cryoablation (Freezing) Instead of Surgery & Radiation for Women Age 50+ with Small Tumors

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

Summary

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

Identifying Cancerous Tissue During Surgery for DCIS or Early Stage Breast Cancer

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

Summary

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


This is a Phase II trial

Comparing Two Types of Tissue Expanders for Breast Reconstruction

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

Summary

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

Radiation Therapy During Surgery for Patients with Stage I-II Breast Cancer

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

Summary

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


This is a Phase II trial

Intensity-Modulated Radiation Therapy After Lumpectomy

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

Summary

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


This is a Phase III trial

Single Fraction Intraoperative Radiotherapy

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

Summary

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


This is a Phase I-II trial

Proton vs. Photon Radiotherapy for DCIS or Stage I-III Breast Cancer

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

Summary

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

Radiation Therapy Before Surgery for ER+, HER2- DCIS or Stage I Breast Cancer

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

Summary

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


This is a Phase II trial

Cyberknife Radiation After Surgery for DCIS or Stage I-II Breast Cancer

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

Summary

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


This is a Phase I trial

Internal Breast Radiation Therapy for Early-Stage Disease

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy (NCT00924027) (NCT00924027)

Summary

Women with ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy (breast conserving surgery) followed by radiation therapy. Brachytherapy is a type of radiation treatment that delivers a high dose of radiation directly to the tumor area. Brachytherapy is delivered through small radioactive seeds that are put into a hollow device that has been placed inside the area of the breast where the DCIS or tumor was removed. Brachytherapy takes less time than traditional radiation therapy. It also reduces the amount of radiation healthy tissue receives. The goal of this study is to evaluate the quality of the brachytherapy procedure being used to treat women with DCIS or early-stage breast cancer at the National Institutes of Health's Radiation Oncology Branch.


This is a Phase II trial

Radiation Before Surgery for Patients 60 & Older with HR+, DCIS or Stage I Breast Cancer

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

Summary

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

Three New Radiation Options Following Lumpectomy or Mastectomy

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

Summary

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


This is a Phase II trial

Cosmetic Results of Lumpectomy & Hypofractionated Radiation

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

Summary

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

Pencil Beam Proton Radiation After Mastectomy for Stage I-III Breast Cancer

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

Summary

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

Targeted Radiation During Surgery to Reduce Recurrence Risk After Lumpectomy

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

Summary

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

Radiation But No Surgery After Chemo in Patients with Triple Negative Stage I-II Tumors

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

Summary

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

Radiation During Lumpectomy Surgery for Stage I-III Breast Cancer

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

Summary

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

Proton Radiation for Stage II-III Breast Cancer

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer (NCT01758445)

Summary

Radiation is often used following surgery to treat breast cancer. Standard X-ray radiation uses particles called photons to kill tumor cells. Proton therapy is an alternative type of radiation therapy that uses particles called protons instead of photons. Studies suggest that proton radiation may result in fewer side effects than traditional X-ray radiation. The purpose of this trial is to study the long-term effects of proton radiotherapy in women with locally advanced breast cancer.


This is a Phase II trial

Partial Breast Radiation After Lumpectomy in Women 50 & Older with Stage I Breast Cancer

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

Summary

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

Lumpectomy Without Radiation for Individuals at Low-Risk of Cancer Coming Back

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

Summary

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

A Study Investigating Best Positioning to Protect Heart and Lungs During Radiation

Prospective Trial of Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy With and Without Respiratory Gating, a Dosimetric Comparison (NCT03037723)

Summary

To take part in this study, you must have been diagnosed with DCIS or stage I-IIA breast cancer in your left breast. You must have had breast conserving surgery (lumpectomy) and be scheduled to have radiation therapy.

This study is investigating whether giving radiation in the face-up position to women with breast cancer in their left breast offers better protection to the heart and lungs than the standard face-down position.

Nipple and Areola Radiation After Nipple-Sparing Mastectomy

A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer (NCT01208974)

Summary

In a nipple-sparing mastectomy all of the breast tissue is removed during surgery, except for the nipple and areola. Researchers believe that administering radiation therapy to the nipple and areola after a nipple-sparing mastectomy can reduce a patient's risk of having a breast cancer recurrence. The goal of this trial is to determine the effectiveness, toxicity, and cosmetic outcome of radiation to the nipple and areola in patients who are having a nipple-sparing mastectomy. The researchers will also be determining the radiation dose that should be used in future studies.

MRI-Guided Targeted Radiation Before Lumpectomy for ER+, Stage I-II Breast Cancer

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

Summary

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


This is a Phase II trial

Radiation Therapy During Surgery for Early-Stage Disease

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

Summary

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

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

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

Summary

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

Partial Breast Radiation for Malignant Phyllodes Tumors

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

Summary

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

Stereotactic Body Radiation Therapy for Breast Cancer with Limited Metastasis

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

Summary

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


This is a Phase II-III trial

Individualized Radiotherapy Education for Patients with Stage I-III Breast Cancer

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

Summary

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

Hypofractionated Radiation Therapy for DCIS or Early Stage Breast Cancer

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

Summary

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


This is a Phase II trial

Intraoperative Radiation for Age 45 and Over with Early Stage Breast Cancer

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

Summary

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


This is a Phase II trial

Lymph Node Dissection & Radiation after Neoadjuvant Therapy to Treat Positive Node(s)

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

Summary

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


This is a Phase III trial

Hypofractionated Radiation After Mastectomy in Stage II-III Breast Cancer

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

Summary

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


This is a Phase III trial

Radiation Therapy During Surgery for Node-Negative Breast Cancer

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

Summary

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

Proton Therapy for Women with Stage IA-IIA Breast Cancer

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

Summary

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


This is a Phase II trial

Breast Seed Implant Radiation Treatment for Women with DCIS or Early-Stage Breast Cancer

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

Summary

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

Proton Radiation Therapy For DCIS and Early-Stage Breast Cancer

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

Summary

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


This is a Phase II trial

Radiation for Women with Stage I-III Disease Who Had Chemo Before Surgery

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant... (NCT01872975)

Summary

Chemotherapy given before surgery (neoadjuvant treatment) can kill cancer cells in the lymph nodes. This means a woman who is initially node positive may be node negative at the time of surgery. The standard of care for women with early-stage breast cancer who have a lumpectomy is whole-breast radiation. Women who have a mastectomy typically do not receive radiation. Giving radiation to the lymph nodes following a lumpectomy and giving radiation to the chest wall and lymph nodes following a mastectomy may be more effective in women who become node negative after neoadjuvant chemotherapy. This study is enrolling women whose lymph node status changed from positive to negative after neoaduvant chemotherapy to see if additional radiation after surgery will reduce the risk of recurrence.

Radiation Treatment During Surgery for DCIS, LCIS and Stage I-II Breast Cancer

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer (NCT02266602)

Summary

Radiation treatments have typically been given after breast cancer surgery. A newer type of treatment allows radiation to be given during surgery. Intraoperative radiation therapy (IORT) delivers a high dose of radiation to the inside of the breast, where the tumor was removed. This study is looking at the effectiveness of using IORT during breast conserving surgery (lumpectomy). To be eligible, you must have DCIS, LCIS or stage I-II breast cancer and not have received chemotherapy before surgery.

Radiation Therapy During Surgery for DCIS

Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)(NCT03216421)

Summary

To take part in this study, you must have been diagnosed with DCIS and be planning to have breast conserving surgery (lumpectomy). In addition, you must have had a diagnostic mammogram within the last 6 months. This study is investigating the safety and effect of using intraoperative radiation therapy (IORT) in women who are having a lumpectomy to treat DCIS. IORT delivers a high dose of radiation during surgery to the area in the breast where the DCIS was removed.

Hypofractionated Radiation and Lymphedema Risk in DCIS & Early Stage Breast Cancer

Shortening Adjuvant Photon Irradiation to Reduce Edema (SAPHIRE): A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer (NCT02912312)

Summary

To take part in this study, you must have been diagnosed with DCIS or early stage (stage I-III) breast cancer. If you have early stage breast cancer, you must have had a lumpectomy or mastectomy as part of your breast cancer treatment. This study will see if women who are treated with hypofractionated radiation to the lymph nodes near the breast are at lower risk of developing lymphedema than women treated with traditional radiation therapy. The researchers will also see if there are differences in the side effects women in each group develop.


This is a Phase II trial

Study of Radiation Techniques to Treat Patients With 5 to 15 Brain Metastases

Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-15 Brain Metastases: A Phase III, Randomized Clinical Trial (NCT03075072)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and have between 5 and 15 brain metastases. This study is investigating whether patients with brain metastases who receive stereotactic radiation have fewer side effects and a better quality of life than those who receive whole brain radiation. Stereotactic radiation delivers focused radiation to each individual brain metastasis. Whole brain radiation treats the entire brain. This study is also open to patients with other types of cancer.


This is a Phase III trial

Three Weeks of Radiation for Women Under 50 with DCIS or Stage I-III Breast Cancer

A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients (NCT03167359)

Summary

To take part in this study, you must have been diagnosed with DCIS or early stage (stage I-III) breast cancer. This study will evaluate the effects (good and bad) of giving 3 weeks of daily radiation therapy after breast surgery (lumpectomy or mastectomy) instead of the standard 6 weeks. The researchers will see if the shorter time period improves women's quality of life and reduces side effects such as lymphedema and fatigue.

Proton Beam Partial Breast Radiation for Early Stage Disease

Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation (NCT01245712)

Summary

The standard treatment for early stage breast cancer is a lumpectomy followed by radiation to kill any cancer cells that may still remain in the breast. Radiation therapy is usually given 5 days a week for up to 7 weeks. Proton-beam partial breast irradiation (PBI) is a newer type of radiation therapy. It is given over a shorter time period, and it directs the radiation to the precise area of the breast where the cancer was removed so that less healthy tissue is affected. The goal of this study is to find out if a 1-week course of proton-beam PBI causes fewer or less severe side effects (such as changes to the breast's appearance) than a longer course of radiation treatment. To be eligible, women must be planning to undergo radiation, and have had or are planning to have a lumpectomy.


This is a Phase II trial

Exercise Program for Women Receiving Radiation for Stage II-III Breast Cancer

Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?(NCT03102866)

Summary

To take part in this study, you must have must have completed surgery and chemotherapy for stage II or III breast cancer and be scheduled to start radiation therapy. This study is investigating whether a supervised aerobic and strength training exercise program helps improve overall fitness as well as arm health in women whose breast cancer is being treated with radiation therapy.

Targeted Radiation Before Surgery for Patients 50 and Older with HR+ Early Stage Disease

A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy (NCT03137693)

Summary

To take part in this study, you must be 50 or older and have HR+ (ER+/PR+), HER2- early stage (stage I-III) breast cancer and not yet have had treatment. This study is investigating the safety and effects (good and bad) of giving targeted radiation directly to the tumor before surgery. Usually, radiation is given after surgery. The radiation therapy used in this study is called Stereotactic Ablative Body Radiotherapy (SABR).

G1T48 for Advanced ER+ HER2- Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer (NCT03455270)

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 been treated with an aromatase inhibitor.

This study will evaluate the safety and effects (good and bad) of a using the hormonal therapy G1T48 to treat ER positive, HER2 negative advanced or metastatic breast cancer. G1T48 is type of hormone therapy called a selective estrogen receptor degrader (SERD).


This is a Phase I trial

Hormone Therapy Before Surgery for Invasive Lobular Breast Cancer

A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer (NCT02206984)

Summary

To take part in this study, you must have invasive lobular breast cancer and not yet had surgery. You must also no longer be getting your period (postmenopausal). This study is looking at which anti-estrogen treatment is best to use before surgery in women who have invasive lobular breast cancer. Each patient in the study will receive one of the three anti-estrogen drugs the researchers are studying. These three drugs are tamoxifen (Nolvadex®), anastrozole (Arimidex®), and fulvestrant (Faslodex®).

Arimidex & Faslodex Before Surgery for Stage II-III ER+, HER2- Breast Cancer

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study (NCT01953588)

Summary

Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study how the treatment affects the breast tumor. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women with metastatic hormone-sensitive tumors. Anastrozole (Arimidex®) is anti-estrogen therapy used to treat postmenopausal women with hormone-sensitive breast cancer. This study is locking at the effect that Arimidex alone, Faslodex alone, or Arimidex and Falsodex in combination have on the tumor when they are given before surgery to postmenopausal women with stage II-III ER-positive, HER2-negative breast cancer.


This is a Phase III trial

Estrogen and an Aromatase Inhibitor in Advanced ER+ Breast Cancer

Phase II Pre-emptive OsciLLation of ER activitY Levels Through Alternation of Estradiol/Anti-estrogen Therapies Prior to Disease Progression in ER+/HER2- Advanced Breast Cancer (NCT02188745)

Summary

Anti-estrogen therapies are used to treat ER+ tumors. However, over time, these tumors can stop responding to these treatments. Laboratory studies suggest that giving a high dose of estrogen to patients whose tumors have stopped responding to an anti-estrogen therapy may get the tumor to respond again to the treatment. This study will investigate how tumors respond when estrogen (17B-estradiol) is given along with an aromatase inhibitor––letrozole (Femara®), anastrozole (Arimidex®) or exemestane (Aromasin®) to treat women with advanced ER+, HER2- metastatic breast cancer. To be eligible for this study, a patient must have been previously treated with tamoxifen, raloxifene, toremifene, or an AI.
This is a Phase II trial

Tamoxifen and Faslodex Before Surgery in Premenopausal Women with ER+ Breast Cancer

Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer (NCT02936206)

Summary

To take part in this study, you must be premenopausal and newly diagnosed with ER-positive, HER2-negative breast cancer. Your tumors must also be cyclin D1-positive and at least 5 mm in size. You must also be scheduled to have surgery at Mount Sinai Hospital in New York. This study is looking at the effect that two different types of anti-estrogen drugs have on breast cancer cells in premenopausal women. The two drugs being studied are tamoxifen (Nolvadex®) and fulvestrant (Faslodex®). Both are used to treat breast cancer. Giving the drugs before surgery allows the researchers to study the effect they have on breast cancer cells.


This is a Phase I trial

H3B-6545 for Postmenopausal Women with ER+, HER2- Breast Cancer

A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (NCT03250676)

Summary

To take part in this study, you must be a postmenopausal woman who has ER+, HER2- advanced (some stage III) or metastatic (stage IV) breast cancer that progressed on your most recent therapy. This study will determine the best dose, safety, and effects (good and bad) of an experimental anti-estrogen drug called H3B-6545.
This is a Phase I-II trial

Effect of Faslodex When Given Before Surgery in ER+ DCIS or Early-Stage Breast Cancer

An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy (NCT02540330)

Summary

Fulvestrant (Faslodex®) is a hormone therapy that is currently used to treat hormone-sensitive (ER+) metastatic breast cancer in postmenopausal women. Researchers are interested in learning the effect that the drug has on DCIS and early-stage breast cancers. They also want to see if the drug has different effects when it is injected into a muscle (how it is used now) or injected directly into the milk ducts, where cancer begins (this is called intraductal therapy). In this study, researchers will compare the safety and effectiveness of Faslodex when it is given before surgery through the muscle or milk duct of women with DCIS or early-stage hormone-sensitive breast cancer. To be eligible, patients must be scheduled to have a surgery within one month.
This is a Phase II trial

Aromasin Before Surgery for Postmenopausal Women with ER+ DCIS or Stage I-II Breast Cancer

Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial (NCT02598557)

Summary

To take part in this study, you must be postmenopausal and have ER+ DCIS or stage I-II breast cancer and have not yet had surgery. This study is evaluating the effectiveness of and side effects associated with three different doses of an anti-estrogen drug given before surgery to treat ER+ DCIS or stage I-II breast cancer. The drug being studied is the aromatase inhibitor exemestane (Aromasin®). Giving the drug before surgery can shrink the tumor. It also allows the researchers to study the effect the drug has on the cancer cells.
This is a Phase II trial

Anti-Estrogen Treatment for Women 75 and Older at Low-Risk for Recurrence

Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score (NCT02476786)

Summary

To take part in this study, you must be age 75 or older and have been diagnosed with ER+, HER2- breast cancer that can be removed by surgery (stage I or stage II). Your tumor test must show that you have a slow-growing cancer and you must not yet have received any treatment for your cancer. This study will evaluate whether it is safe and effective to use anti-estrogen drugs alone to treat women age 75 and older. Your doctor will choose which anti-estrogen drug you receive: goserelin (Zoladex®), anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), fulvestrant (Faslodex®), or tamoxifen (Nolvadex®). You will not have surgery, radiation, or chemotherapy unless your tumor starts to grow or you decide you want to have these treatments. Ki67 is a protein found in cancer cells. By measuring the amount of the protein in the cancer cells, researchers can learn how quickly the cancer cells are growing. To be in this study, you must have a slow-growing cancer, with a Ki67 score that is less than 10%.
This is a Phase II trial

Tamoxifen Delivered Through the Breast Skin to Control ER+ DCIS Before Surgery

Phase IIB Trial of Neoadjuvant Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast (NCT02993159)

Summary

To take part in this study, you must have recently been diagnosed with ER+ DCIS and not yet had surgery. This study will compare the effect of tamoxifen (given orally) to an afimoxifene gel (applied to the breast before surgery) on the KI-67 protein in women with ER+ DCIS who are going to have surgery. The Ki-67 protein increases as the cell prepares to divide into new cells. Afimoxifene gel (TamoGel) is a topical anti-estrogen gel that is applied to the skin to relieve breast pain. Tamoxifen citrate (Nolvadex ®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.
This is a Phase II trial

Hormone Therapy Before Surgery in HR-Positive HER2-Negative Breast Cancer Patients

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance (NCT03219476)

Summary

To take part in this study, you must have estrogen receptor positive, HER2 negative, node-negative breast cancer.

Researches are conducting this study to learn more about how breast tumors respond to different types of hormone therapies. Giving the hormone therapy before surgery (called neoadjuvant treatment) allows the researchers to study the effect it has on the cancer cells. There are four hormone therapies being used in this study. Three of them are aromatse inhibitors: anastrozole (Armidex®), letrozole (Femara®) and exemestane (Aromasin®). These hormone therapies are only used to treat postmenopausal women. The fourth hormone therapy is tamoxifen (Nolvadex ®). It is used to treat both pre-and postmenopausal women. Your doctor will decide which hormone therapy you should receive based on your medical history and menstrual status.


This is a Phase II trial

Fulvestrant plus Enzalutamide Before Surgery in AR+, ER+, HER2- Breast Cancer

Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer (NCT02955394)

Summary

To take part in this study, you must have been diagnosed with certain types of stage II and stage III, ER+, HER2- breast cancer. Your tumor most also be tested for and found to be androgen receptor positive (AR+). This study is investigating the safety and effects (good or bad) of giving an anti-estrogen drug along with an anti-androgen drug before surgery. Fulvestrant (Faslodex®) is the anti-estrogen drug being used in this study. It is approved to treat postmenopausal women with metastatic breast cancer. The anti-androgen drug used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer. If you are pre- or peri- menopausal, you will also receive a drug to shut down your ovaries.
This is a Phase II trial

RAD140 for Postmenopausal Women With HR+Advanced Breast Cancer

A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer (NCT03088527)

Summary

To take part in this study, you must be postmenopausal and have HR-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, best dose, and effects (good or bad) of an investigational hormone therapy called RAD140 in patients whose tumors are no longer responding to standard treatme


This is a Phase I trial

Faslodex or Tamoxifen for ER-Positive Metastatic Breast Cancer

Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen: A Randomized Phase II Trial With ESR1 Mutation Tested in Circulating Tumor DNA (NCT02913430)

Summary

To take part in this study, you must have ER-positive metastatic breast cancer. You must also have not been treated with Faslodex or tamoxifen since being diagnosed with metastatic breast cancer. This study is comparing how well two different anti-estrogen drugs keep metastatic breast cancer from spreading. The two drugs are fulvestrant (Faslodex®) and tamoxifen (Nolvadex®). Both are used to treat metastatic breast cancer. The researchers will use blood tests to study each patient's circulating tumor DNA—DNA from the cancer that floats in the blood stream—in order to learn more about a mutation called ESR1 and why hormone-sensitive tumors stop responding to anti-estrogen treatments.


This is a Phase II trial

Hormone Therapy & Afinitor in Breast Cancer Patients at High Risk for Recurrence

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer (NCT01674140)

Summary

Using two cancer treatments that work in different ways may be a more effective way to treat certain types of breast tumors. Everolimus (Afinitor®) is a newer type of targeted therapy called an mTOR inhibitor. It is used along with the hormone therapy exemestane (Aromasin®) to treat advanced ER+, HER2- breast cancer. Researchers are interested in seeing if Afinitor will be beneficial to women with early-stage breast cancer. This study is looking at whether using one year of Afinitor along with standard hormone therapy is more effective than standard hormone therapy alone in patients with ER+, HER2- breast cancer who are at high risk for recurrence.
This is a Phase III 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

PF-05212384 for Triple Negative Breast Cancer

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

Summary

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

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

  • Participation TimeVisits every 3 weeks, ongoing