NCI Clinical Trials

This is a listing of Clinical Trials from the US National Cancer Institute (NCI) for breast cancer that accept men.

It was compiled by searching the NCI Clinical Trials data base with the term “breast – Male” in the “anatomic_sites” field using the published API, and restricting the results to Active trials with a status change in the last 6 months, which is hopefully the best way currently to find the newest trials (improvements coming in the database for this, I understand from the NCI’s API webpage.

This list therefore may contain the most recent trials to come on line for which men with breast cancer are eligible. Please explore the trials, and read details on their main pages on the NCI webpage, via the links provided.

This listing contains 23 trials, and was last updated on 2020-03-29

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A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

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

Phase III

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

This trial may be offered at the following sites in the US (please check with center directly):

Stanford Cancer Institute Palo Alto, Palo Alto CA | Northwestern University, Chicago IL | University of Pittsburgh Cancer Institute (UPCI), Pittsburgh PA |

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Last status change to Active was on 2020-03-17.

For the complete listing see here: NCI-2018-00209

ASTX727 and Talazoparib for the Treatment of Triple Negative or Hormone Resistant / HER2-Negative Metastatic Breast Cancer

A Phase I Study of ASTX727 plus Talazoparib in Patients with Triple Negative or Hormone Resistant / HER2-Negative Metastatic Breast Cancer

Phase I

This phase I trial studies the side effects and best dose of ASTX727 and talazoparib in treating patients with triple negative or hormone resistant / HER2-negative breast cancer that has spread to other places in the body (metastatic). ASTX727 is a combination of two chemotherapy drugs, cedazuridine and decitabine, and may increase the immune system’s response to cancer and talazoparib. Talazoparib is an anticancer drug called a PARP (poly ADP ribose polymerase) inhibitor and is in development for the treatment of a variety of cancers. The combination of ASTX727 and talazoparib may help boost the immune system to stop or reverse the growth of tumors.

This trial may be offered at the following sites in the US (please check with center directly):

Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis IN |

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Last status change to Active was on 2020-03-03.

For the complete listing see here: NCI-2019-07890

Abemaciclib Monotherapy in Treating Older Patients with Hormone Receptor Positive Metastatic Breast Cancer

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older with Hormone Receptor Positive Metastatic Breast Cancer

Phase II

This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.

This trial may be offered at the following sites in the US (please check with center directly):

City of Hope Comprehensive Cancer Center, Duarte CA |

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Last status change to Active was on 2020-02-21.

For the complete listing see here: NCI-2019-08847

Testing the Ability to Decrease Chemotherapy in Patients with HER2-Positive Breast Cancer Who Have No Remaining Cancer at Surgery after Limited Pre-operative Chemotherapy and HER2-Targeted Therapy

(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response

Phase II

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of “targeted therapy” because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

This trial may be offered at the following sites in the US (please check with center directly):

Mercy Hospital Fort Smith, Ft. Smith AR | Kingman Regional Medical Center, Kingman AZ | PCR Oncology, Arroyo Grande CA | Stamford Hospital / Bennett Cancer Center, Stamford CT | Beebe Medical Center, Lewes DE | Delaware Clinical and Laboratory Physicians PA, Newark DE | Medical Oncology Hematology Consultants PA, Newark DE | Helen F Graham Cancer Center, Newark DE | Christiana Care Health System-Christiana Hospital, Newark DE | Beebe Health Campus, Rehoboth Beach DE | Nanticoke Memorial Hospital, Seaford DE | Christiana Care Health System-Wilmington Hospital, Wilmington DE | McFarland Clinic PC – Ames, Ames IA | Mary Greeley Medical Center, Ames IA | McFarland Clinic PC-Boone, Boone IA | McFarland Clinic PC-Trinity Cancer Center, Fort Dodge IA | McFarland Clinic PC-Jefferson, Jefferson IA | McFarland Clinic PC-Marshalltown, Marshalltown IA | Illinois CancerCare-Bloomington, Bloomington IL | Illinois CancerCare-Canton, Canton IL | Memorial Hospital of Carbondale, Carbondale IL | SIH Cancer Institute, Carterville IL | Illinois CancerCare-Carthage, Carthage IL | Centralia Oncology Clinic, Centralia IL | Swedish Covenant Hospital, Chicago IL | Decatur Memorial Hospital, Decatur IL | Cancer Care Specialists of Illinois – Decatur, Decatur IL | Illinois CancerCare-Dixon, Dixon IL | Crossroads Cancer Center, Effingham IL | Illinois CancerCare-Eureka, Eureka IL | Western Illinois Cancer Treatment Center, Galesburg IL | Illinois CancerCare-Galesburg, Galesburg IL | Illinois CancerCare-Kewanee Clinic, Kewanee IL | Illinois CancerCare-Macomb, Macomb IL | Good Samaritan Regional Health Center, Mount Vernon IL | Illinois CancerCare-Ottawa Clinic, Ottawa IL | Illinois CancerCare-Pekin, Pekin IL | Methodist Medical Center of Illinois, Peoria IL | Illinois CancerCare-Peoria, Peoria IL | Illinois CancerCare-Peru, Peru IL | Valley Radiation Oncology, Peru IL | Illinois CancerCare-Princeton, Princeton IL | Memorial Medical Center, Springfield IL | Springfield Clinic, Springfield IL | Southern Illinois University School of Medicine, Springfield IL | Cancer Care Specialists of Illinois-Swansea, Swansea IL | Southwest Illinois Health Services LLP, Swansea IL | Beverly Hospital, Beverly MA | Lahey Hospital and Medical Center, Burlington MA | Addison Gilbert Hospital, Gloucester MA | Winchester Hospital, Winchester MA | Lafayette Family Cancer Center-EMMC, Brewer ME | Ascension Providence Hospitals – Novi, Novi MI | Ascension Providence Hospitals – Southfield, Southfield MI | Saint Louis Cancer and Breast Institute-Ballwin, Ballwin MO | Cox Cancer Center Branson, Branson MO | Southeast Cancer Center, Cape Girardeau MO | Saint Francis Medical Center, Cape Girardeau MO | Parkland Health Center – Farmington, Farmington MO | Capital Region Southwest Campus, Jefferson City MO | Mercy Hospital Joplin, Joplin MO | Freeman Health System, Joplin MO | Mercy Clinic-Rolla-Cancer and Hematology, Rolla MO | Delbert Day Cancer Institute at PCRMC, Rolla MO | Heartland Regional Medical Center, Saint Joseph MO | Mercy Hospital South, Saint Louis MO | Saint Louis Cancer and Breast Institute-South City, Saint Louis MO | Missouri Baptist Medical Center, Saint Louis MO | Mercy Hospital Saint Louis, Saint Louis MO | Sainte Genevieve County Memorial Hospital, Sainte Genevieve MO | Mercy Hospital Springfield, Springfield MO | CoxHealth South Hospital, Springfield MO | Missouri Baptist Sullivan Hospital, Sullivan MO | Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills MO | Mercy Hospital Washington, Washington MO | New Hampshire Oncology Hematology PA-Concord, Concord NH | New Hampshire Oncology Hematology PA-Hooksett, Hooksett NH | The Cancer Institute of New Jersey Hamilton, Hamilton NJ | Rutgers Cancer Institute of New Jersey, New Brunswick NJ | Carson Tahoe Regional Medical Center, Carson City NV | OptumCare Cancer Care at Seven Hills, Henderson NV | Cancer and Blood Specialists-Henderson, Henderson NV | Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson NV | Comprehensive Cancer Centers of Nevada – Henderson, Henderson NV | 21st Century Oncology-Henderson, Henderson NV | Las Vegas Urology – Green Valley, Henderson NV | Urology Specialists of Nevada – Green Valley, Henderson NV | Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson NV | Las Vegas Cancer Center-Henderson, Henderson NV | Las Vegas Urology – Pebble, Henderson NV | Ann M Wierman MD LTD, Las Vegas NV | HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway, Las Vegas NV | Sunrise Hospital and Medical Center, Las Vegas NV | OptumCare Cancer Care at Fort Apache, Las Vegas NV | Hope Cancer Care of Nevada, Las Vegas NV | Desert West Surgery, Las Vegas NV | Comprehensive Cancer Centers of Nevada – Central Valley, Las Vegas NV | Radiation Oncology Centers of Nevada Central, Las Vegas NV | Cancer and Blood Specialists-Shadow, Las Vegas NV | Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas NV | Comprehensive Cancer Centers of Nevada – Northwest, Las Vegas NV | University Cancer Center, Las Vegas NV | 21st Century Oncology, Las Vegas NV | OptumCare Cancer Care at MountainView, Las Vegas NV | Las Vegas Urology – Cathedral Rock, Las Vegas NV | 21st Century Oncology-Vegas Tenaya, Las Vegas NV | Urology Specialists of Nevada – Northwest, Las Vegas NV | Comprehensive Cancer Centers of Nevada – Town Center, Las Vegas NV | HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills, Las Vegas NV | 21st Century Oncology-Fort Apache, Las Vegas NV | Alliance for Childhood Diseases / Cure 4 the Kids Foundation, Las Vegas NV | Cancer and Blood Specialists-Tenaya, Las Vegas NV | Comprehensive Cancer Centers of Nevada, Las Vegas NV | Urology Specialists of Nevada – Southwest, Las Vegas NV | OptumCare Cancer Care at Oakey, Las Vegas NV | HealthCare Partners Medical Group Oncology / Hematology-San Martin, Las Vegas NV | University Medical Center of Southern Nevada, Las Vegas NV | Radiation Oncology Centers of Nevada Southeast, Las Vegas NV | Las Vegas Urology – Pecos, Las Vegas NV | Summerlin Hospital Medical Center, Las Vegas NV | Las Vegas Urology – Smoke Ranch, Las Vegas NV | Las Vegas Urology – Sunset, Las Vegas NV | Las Vegas Cancer Center-Medical Center, Las Vegas NV | Urology Specialists of Nevada – Central, Las Vegas NV | HealthCare Partners Medical Group Oncology / Hematology-Tenaya, Las Vegas NV | Las Vegas Prostate Cancer Center, Las Vegas NV | Hope Cancer Care of Nevada-Pahrump, Pahrump NV | Renown Regional Medical Center, Reno NV | Saint Mary’s Regional Medical Center, Reno NV | Radiation Oncology Associates, Reno NV | Montefiore Medical Center-Weiler Hospital, Bronx NY | Montefiore Medical Center – Moses Campus, Bronx NY | Montefiore Medical Center-Einstein Campus, Bronx NY | University of Rochester, Rochester NY | Mercy Hospital Oklahoma City, Oklahoma City OK | Christiana Care Health System-Concord Health Center, Chadds Ford PA | Reading Hospital, West Reading PA | Overlake Hospital Medical Center, Bellevue WA | Valley Medical Center, Renton WA | Saint Vincent Hospital Cancer Center Green Bay, Green Bay WI | Saint Vincent Hospital Cancer Center at Saint Mary’s, Green Bay WI | Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls WI | Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay WI |

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Last status change to Active was on 2020-02-11.

For the complete listing see here: NCI-2019-07439

ONC201 in Recurrent / Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma

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

Phase II

Background: The new drug ONC201 have been shown to kill breast cancer and endometrial cancer cells in the laboratory. The exact mechanism of action is not completely clear yet, but the ONC201 destroys the mitochondria inside the cells. Blocking mitochondrial activity may kill tumor cells, which would shrink tumors. Researchers want to see if ONC201 helps shrink tumors of certain breast or endometrial cancers and if that effect is maintained. Objective: To see if ONC201 shrinks tumors with a lasting effect. Eligibility: Adults ages 18 and older who have metastatic breast cancer (hormone-positive or triple-negative) or metastatic endometrial cancers. Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests CT and bone scans Review of medical report and tumor sample Participants will have a tumor biopsy before starting treatment and after 5 weeks taking the study drug. A scan or ultrasound may be used to guide the biopsy. Patients will receive local anesthetic and a needle will remove a small piece of tumor. The study will be done in 28-day cycles. Every day 1 of each cycle participants will repeat most screening tests, will be seen by the physician and receive a supply of the study drug. Participants will take the study drug by mouth once every 7 days. They will keep a diary of when they take the drug and any side effects. During cycle 1, participants will get weekly calls to discuss their health and symptoms. Images will be repeated every 2 cycles to evaluate reponse to the treatment. …

This trial may be offered at the following sites in the US (please check with center directly):

National Institutes of Health Clinical Center, Bethesda MD |

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Last status change to Active was on 2020-02-11.

For the complete listing see here: NCI-2018-03626

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer with PIK3CA or PTEN Alterations

A Phase-2, Two-Cohort Trial of Neoadjuvant Nab-Paclitaxel and Alpelisib in Anthracycline Refractory Triple Negative Breast Cancer with PIK3CA or PTEN Alterations

Phase II

This phase II trial studies how well nab-paclitaxel and alpelisib works in treating patients with triple negative breast cancer with PIK3CA or PTEN alterations that does not respond to anthracycline chemotherapy (anthrocycline refractory). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nab-paclitaxel and alpelisib before surgery may help shrink the tumor before surgery.

This trial may be offered at the following sites in the US (please check with center directly):

M D Anderson Cancer Center, Houston TX |

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Last status change to Active was on 2020-02-05.

For the complete listing see here: NCI-2019-08495

DS8201a and Pembrolizumab in Participants With Locally Advanced / Metastatic Breast or Non-Small Cell Lung Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced / Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

Phase I

This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

This trial may be offered at the following sites in the US (please check with center directly):

UCSF Medical Center-Mount Zion, San Francisco CA |

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Last status change to Active was on 2020-02-01.

For the complete listing see here: NCI-2020-01136

A Study of ZN-c5 in Participants With Breast Cancer

A Phase 1 Open-Label, Multicenter Study to Evaluate Biomarkers for ZN-c5 in Subjects With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

Phase I

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

This trial may be offered at the following sites in the US (please check with center directly):

NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York NY | Vanderbilt University / Ingram Cancer Center, Nashville TN | Fred Hutch / University of Washington Cancer Consortium, Seattle WA |

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Last status change to Active was on 2020-01-03.

For the complete listing see here: NCI-2019-08793

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009 / KEYLYNK-009)

An Open-label, Randomized, Phase 2 / 3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

Phase II_III

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab prolongs progression-free survival (PFS) compared with chemotherapy plus pembrolizumab. 2. Olaparib plus pembrolizumab is non-inferior to chemotherapy plus pembrolizumab in terms of overall survival (OS). 3. Olaparib plus pembrolizumab prolongs OS compared with chemotherapy plus pembrolizumab.

This trial may be offered at the following sites in the US (please check with center directly):

UCSF Medical Center-Mount Zion, San Francisco CA |

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Last status change to Active was on 2019-12-30.

For the complete listing see here: NCI-2020-00072

Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer Spread to the Bones

Phase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast Cancer

Phase II

This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.

This trial may be offered at the following sites in the US (please check with center directly):

Rutgers Cancer Institute of New Jersey, New Brunswick NJ |

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Last status change to Active was on 2019-12-27.

For the complete listing see here: NCI-2019-06088

Curcumin for the Treatment of Stage I-III Invasive Breast Cancer in Patients Undergoing Surgery

A “Window Trial” on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors

Phase I

This trial studies curcumin for the treatment of stage I-III invasive breast cancer in patients undergoing surgery. Curcumin is a supplement made from the turmeric plant, which has anti-inflammatory effects, and may decrease the number of cancer cells in the body. This is a window of opportunity study, i.e., a study where an anti-cancer drug is given for a few weeks before surgery. Comparing tissue from the original biopsy with tissue from surgery shows the effects the study drug may have had on the tumor.

This trial may be offered at the following sites in the US (please check with center directly):

Medical University of South Carolina, Charleston SC |

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Last status change to Active was on 2019-12-16.

For the complete listing see here: NCI-2020-00423

A Study of TAS-120 in Patients With Metastatic Breast Cancer

A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

Phase II

The purpose of this open-label, nonrandomized, Phase 2 study is to evaluate the efficacy and safety of TAS-120 and TAS-120 + fulvestrant in patients with locally advanced / metastatic breast cancer harboring FGFR gene amplifications.

This trial may be offered at the following sites in the US (please check with center directly):

M D Anderson Cancer Center, Houston TX |

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Last status change to Active was on 2019-12-15.

For the complete listing see here: NCI-2019-07729

Topical Caffeine Compound for the Reduction of Complications in Patients with Stage 0-III Breast Cancer Undergoing Radiation Therapy, ReDCoAT Study

Radiation Dermatitis: A Phase II, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-Based Antifibrosis Cream in Patients with Breast Cancer Undergoing Radiation Therapy

Phase II

This phase II trial studies the side effects of topical caffeine compound and to see how well it works in reducing the complications in patients with stage 0-III breast cancer who are undergoing radiation therapy. Radiation therapy (RT) is a key component of treatment for some breast cancer patients. Radiation-induced fibrosis (RIF) of the skin and subcutaneous tissues is a potential complication that can occur months after RT and progress over several years. RIF is a common adverse outcome in breast cancer patients. The skin and superficial tissues receive almost full dose of radiation and are at risk for RIF. Applying topical caffeine compound to the skin during the RT may help to reduce the risk for RIF.

This trial may be offered at the following sites in the US (please check with center directly):

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York NY |

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Last status change to Active was on 2019-12-13.

For the complete listing see here: NCI-2019-08948

Chemokine Modulation Therapy and Standard Chemotherapy before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer

Phase I Clinical Trial Assessing the Combination of Chemokine Modulation with Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Phase I

This phase I trial studies the side effects and best dose of chemokine modulation therapy when given together with standard chemotherapy given before surgery in treating patients with early stage triple negative breast cancer. Chemokines are molecules that are involved in a variety of immune and inflammatory responses. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may modify the immune response and tumor-related processes and may stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Roswell Park Cancer Institute, Buffalo NY |

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Last status change to Active was on 2019-12-06.

For the complete listing see here: NCI-2019-05299

A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.

A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

Phase III

This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | Emory University Hospital / Winship Cancer Institute, Atlanta GA |

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Last status change to Active was on 2019-11-22.

For the complete listing see here: NCI-2019-08321

A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer

A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects

Phase I

This trial is being conducted to investigate the safety, tolerability, pharmacokinetics (the effect the body has on the drug), and pharmacodynamics (the effect the drug has on the body) of GMI-1359 when given with standard-of-care treatment to subjects with HR+ metastatic breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Duke University Medical Center, Durham NC |

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Last status change to Active was on 2019-11-21.

For the complete listing see here: NCI-2019-08813

Testing the Addition of an Anti-cancer Drug, M6620, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative or Estrogen and / or Progesterone Receptor Positive, HER2 Negative Breast Cancer

A Phase 1b Study of M6620 in Combination with Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and / or Progesterone Receptor Positive, HER2 Negative Breast Cancer

Phase I

This phase Ib trial studies the best dose of M6620 when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and / or progesterone receptor positive, HER-2 negative breast cancer. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving M6620 and radiation therapy may kill tumor cells more effectively than radiation alone or shrink or stabilize breast cancer for longer than radiation therapy alone.

This trial may be offered at the following sites in the US (please check with center directly):

Rutgers Cancer Institute of New Jersey, New Brunswick NJ | Ohio State University Comprehensive Cancer Center, Columbus OH |

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Last status change to Active was on 2019-11-20.

For the complete listing see here: NCI-2019-05187

Phase 1 / 1b Study of Oral PMD-026 in Patients With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

Phase 1 / 1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer

Phase I

The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer and triple negative breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer and triple negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Ohio State University Comprehensive Cancer Center, Columbus OH |

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Last status change to Active was on 2019-11-14.

For the complete listing see here: NCI-2020-01104

Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3)

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination With Front-line Treatment Regimens in Patients With Locally Advanced and / or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma

Phase II

MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical’s first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | University of Colorado Hospital, Aurora CO | Moffitt Cancer Center, Tampa FL |

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Last status change to Active was on 2019-10-31.

For the complete listing see here: NCI-2019-07792

Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer

A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Phase III

A randomized multi-arm study evaluating the safety and efficacy of nivolumab versus placebo in combination with paclitaxel in participants with ER+ / HER2- breast cancer

This trial may be offered at the following sites in the US (please check with center directly):

Rutgers Cancer Institute of New Jersey, New Brunswick NJ |

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Last status change to Active was on 2019-10-25.

For the complete listing see here: NCI-2019-07321

Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer – Dose-Finding Study

A Randomized Phase I / II Trial of Fulvestrant and Abemaciclib in Combination with Copanlisib (FAC) versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)

Phase I_II

This phase I / II trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative stage IV breast cancer. Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

University of Kentucky / Markey Cancer Center, Lexington KY | Ohio State University Comprehensive Cancer Center, Columbus OH |

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Last status change to Active was on 2019-10-21.

For the complete listing see here: NCI-2019-02752

Talimogene Laherparepvec with Paclitaxel or Endocrine Therapy in Treating Participants with Metastatic, Unresectable, or Recurrent HER2- Negative Breast Cancer

A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination with Paclitaxel or Endocrine Therapy in Patients with Metastatic, Unresectable, or Locoregionally Recurrent HER2-Negative Breast Cancer with Evidence of Injectable Disease in the Locoregional Area

Phase I

This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with paclitaxel or endocrine therapy in treating participants with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body, cannot be removed by surgery, or has come back after. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with paclitaxel or endocrine therapy may work better in treating participants with HER2-negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

UCSF Medical Center-Mount Zion, San Francisco CA |

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Last status change to Active was on 2019-10-10.

For the complete listing see here: NCI-2018-00652

Sacituzumab Govitecan and Talazoparib for the Treatment of Stage IV Triple-Negative Breast Cancer

Phase 1b / 2 Study to Evaluate Safety and Anti-Tumor Activity of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer

Phase I_II

This phase Ib / II trial studies the side effects and best dose of sacituzumab govitecan and talazoparib in treating patients with stage IV triple-negative breast cancer. Sacituzumab govitecan is an antibody-drug conjugate which means it’s made up of an antibody attached to an anticancer drug. An antibody is a protein normally made by the immune system (the system in the body that fights off diseases). Sacituzumab govitecan is believed to work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent the tumor cells from growing / spreading. Talazoparib belongs to a group of drugs called PARP inhibitors. PARP is a protein that is involved with repairing damaged deoxyribonucleic acid (DNA) (the genetic material of cells). Talazoparib is believed to work by inhibiting (stopping) the PARP proteins from working in tumor cells so that the cancer cannot fix its damaged DNA. Sacituzumab govitecan and talazoparib may help stop tumors from growing and spreading by administering an anticancer drug directly to the cancerous tumor(s) through sacituzumab govitecan and by stopping the cancer’s cells from fixing its damaged DNA through talazoparib.

This trial may be offered at the following sites in the US (please check with center directly):

Massachusetts General Hospital Cancer Center, Boston MA | Brigham and Women’s Hospital, Boston MA | Dana-Farber Cancer Institute, Boston MA |

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Last status change to Active was on 2019-10-03.

For the complete listing see here: NCI-2019-07939