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New Trials

The following trials have been newly listed or updated within the last 2 weeks.

Leronlimab & Carboplatin for Metastatic Triple Negative Breast Cancer That Tests CCR5+

A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)(NCT03838367)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that the researchers find tests positive for CCR5, have received an anthracycline and a taxane before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy), and not have been treated with chemotherapy or a checkpoint inhibitor for metastatic breast cancer.

This study is investigating the best dose, safety and effects (good and bad) of leronlimab when it is used along with carboplatin. Leronlimab is an investigational targeted therapy that blocks CCR5. Carboplatin is a chemotherapy drug used to treat breast cancer.


This is a Phase I-II trial

TTC-352 in Metastatic ER Positive Breast Cancer That Has Progressed on Endocrine Therapy

Phase 1 Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy (NCT03201913)

Summary

To take part in this study you must have metastatic (stage IV) estrogen receptor (ER) positive, HER2 negative breast cancer that has progressed on at least two lines of hormone therapy, with one line that included a CDK4/CDK6 inhibitor (e.g., palbociclib or ribociclib).

This study is investigating the safety, best dose, and effects (good and bad) of TTC-352. This investigational drug is a new type of hormone therapy. In laboratory studies, TTC-352 has been shown to slow the growth of tamoxifen-resistant cancer cells.


This is a Phase I trial

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Phase 2 Trial With Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337 (NCT03911973)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have a triple negative (ER-, PR-, HER2-) tumor or be BRCA1/2+ and have a HER2 negative tumor. This study is investigating the safety, best dose, and effects (good or bad) of gedatolisib when it is used in combination with talazoparib (Talzenna®). Gedatolisib is an experimental targeted therapy that works by blocking two proteins, called PI3K and mTOR, that help tumors grow. Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat HER2 negative advanced or metastatic breast cancer in women and men with an inherited BRCA mutation.
This is a Phase I-II trial

Alpelisib & Enzalutamide in Advanced Breast Cancer That Tests AR+ and PTEN+

Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer (NCT03207529)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER positive and/or PR positive) or triple negative (ER-, PR-, HER2-) breast cancer that tests AR-positive and PTEN-positive and has been treated with at least one standard therapy.

This study will investigate the best dose, safety, and effects (good and bad) of alpelisib (Piqray®) when it is used along with enzalutamide (Xtandi®). Piqray is a targeted therapy that inhibits PI3K. It is approved to treat advanced hormone receptor positive, HER2 negative breast cancer in patients with a tumor that has a PIK3CA mutation. Xtandi is an oral drug that targets the androgen receptor (AR). It is approved to treat advanced prostate cancer.


This is a Phase I trial

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA) (NCT03742102)

Summary

To take part in this study you must be a woman with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) who is being treated for the first time for metastatic disease.

This study will look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies. Imfinzi is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. Taxol is a chemotherapy drug routinely used to treat breast cancer. The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.


This is a Phase I-II trial

Simvastatin With Anti-HER2 Therapy in Patients With HER2-Positive Metastatic Breast Cancer

A Phase II Single Arm Trial of Adding Simvastatin to Dual Anti-HER2 Therapy in Patients With HER2-Positive Metastatic Breast Cancer (SIMPHONY) (NCT03324425)

Summary

To take part in this study you must have metastatic (stage IV) HER2 positive breast cancer that is being treated with two types of anti-HER2 therapies, but has stopped responding.

This study is looking at the effects of using simvastatin (Zocor®) along with dual anti-HER2 therapy. Zocor is a drug that is approved to treat high cholesterol. Laboratory studies suggest that it can get tumors to start responding again to HER2-targeted therapies. The two HER2-targeted therapies you will be on in this study are those your doctor selected for you.


This is a Phase II trial

Talazoparib and Avelumab for Advanced Breast Cancer (TALAVE)

TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer (NCT03964532)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that has not been treated with a PARP inhibitor.

This study is investigating the safety and effects (good and bad) of talazoparib (Talzenna®) when it is used along with avelumab (Bavencio®). Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat patients with an inherited BRCA mutation who have advanced HER2-negative breast cancer. Bavencio is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of lung cancer. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03170960)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has already been treated with at least one line of therapy.

This study will assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®). Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy drug Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. This study also is enrolling patients with other types of cancer.


This is a Phase I-II trial

IPI-549 and Nivolumab in Advanced Triple Negative Breast Cancer

A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors (NCT02637531)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with a cytotoxic chemotherapy but not an anti-PD-1 or anti-PD-L1 immunotherapy.

This study is investigating the safety and effects (good and bad) of IPI-549 when it is used in combination with nivolumab (Opdivo®). Opdivo is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor. Blocking PD-1 helps immune cells see and go after cancer cells. Opdivo is approved to treat at least eight types of cancer. Its use in breast cancer is considered experimental. IPI-549 is an investigational targeted therapy that blocks an enzyme called PI3K, which plays a role in cancer cell growth.


This is a Phase I trial

RO6874281 Alone or With Trastuzumab For Advanced Breast Cancer

An Open-Label,Multicenter,Dose-Escalation,Phase Ia/Ib Study to Evaluate Safety,Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP),as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) (NCT02627274)

Summary

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

This study will test the safety and effects (good and bad) of RO6874281 when it is given alone or with trastuzumab (Herceptin®). Herceptin is a HER2-targeted therapy used to treat breast cancer. RO6874281 is an investigational targeted therapy that blocks FAP and IL2a. It stimulates immune cells to go after tumor cells. This study also is enrolling patients with other types of cancer.


This is a Phase I trial

IACS-010759 for Advanced Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of IACS-010759 in Subjects With Advanced Solid Tumors and Lymphoma (NCT03291938)

Summary

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

This study will identify the best dose and effects (good and bad) of an investigational drug called IACS-010759. This drug is a new type of targeted therapy called an oxidative phosphorylation inhibitor. It targets a protein called NADH ubiquinone oxidoreductase. Laboratory studies have shown blocking this protein can stop the growth of cancer cells. This study is also enrolling patients with other types of cancer.


This is a Phase I trial

  • Participation Time2 hospital stays over the first 2 months; number of additional visits unavailable
  • Participating research sites
    Research sites: 1 site total

KN026 for Advanced HER2 Positive Breast Cancer

Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors (NCT03847168)

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, best dose and effects (good and bad) of KN026, an experimental HER2 targeted therapy. This study also is enrolling patients with stomach cancer.


This is a Phase I trial

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma (NCT03789097)

Summary

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

This study is testing the safety and effects (good and bad) of an experimental immunotherapy injected into metastases when combined with radiation and pembrolizumab (Keytruda®). The immunotherapies injected into the metastases are flt3L and poly-ICLC. Flt3L is an immune cell growth factor. It gets the body to make more immune cells. Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. Radiation therapy will be targeted at the same metastases as these immunotherapies. Keytruda is a type of immunotherapy called a PD-1 inhibitor that is given intravenously (IV). It stimulates the body's immune system to go after cancer cells. It is approved to treat more than 10 types of cancer. Its use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancer.


This is a Phase I-II trial

Personalized Immunotherapy With or Without Opdivo for HR+ Metastatic Breast Cancer

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors(NCT03970382)

Summary

To take part in this study you must have metastatic (stage IV) estrogen receptor-positive breast cancer that has been treated with at least one standard therapy.

This study is evaluating the safety and the effects (good or bad) of an experimental T cell immunotherapy called neoTCR-P1 when it is given with or without nivolumab (Opdivo®). NeoTCR-P1 makes a patient's T cells target a neoepitope (neoE) that is found on their cancer cells. Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.


This is a Phase I trial

Four Immunotherapy Combinations in Advanced Triple Negative Breast Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer(NCT03742349)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-); have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment.

This study will investigate the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab. Spartalizumab is an investigational PD-1 immune checkpoint inhibitor. LAG525 is an investigational immune checkpoint inhibitor that targets LAG-3. NIR178 is an investigational immunotherapy. Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth. MCS110 is an investigational immunotherapy that targets M-CSF. Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.


This is a Phase I trial

XmAb®22841 and Pembrolizumab in Advanced Triple Negative Breast Cancer

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4)(NCT03849469)

Summary

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

This study is investigating the best dose, safety and effects of XmAb22841 when it is used alone or in combination with pembrolizumab (Keytruda®). XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancers.


This is a Phase I trial

Telephone Support to Reduce Fatigue for Metastatic Breast Cancer Patients

Telephone Support for Metastatic Breast Cancer Patients (NCT03998618)

Summary

To take part in this study you must be a woman with stage IV metastatic breast cancer who is being treated at the Indiana University (IU) Simon Cancer Center, Eskenazi Health, IU Health North, IU Health Bloomington, IU Health Ball Memorial, Franciscan Health, or St. Vincent Health.

This study is evaluating whether a telephone-based psychotherapy program can reduce fatigue and improve activity level, mood, and cognition. The type of psychotherapy being studied is called Acceptance and Commitment Therapy (ACT). It teaches mindfulness exercises as well as ways to identify and engage in activities consistent with your personal values.


This is a Phase II trial