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New Trials

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

Immunotherapy and Chemotherapy Before Surgery to Treat Triple Negative Breast Cancer

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NeoPACT) (NCT03639948)

Summary

To take part in this study you must be a woman or man with stage I, II or III triple-negative (ER-/PR-/HER2-) breast cancer who has not yet started treatment.

This study is investigating the effect of using the immunotherapy pembrolizumab (Keytruda®) along with chemotherapy before surgery (neoadjuvant therapy). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and docetaxel (Taxotere®) are chemotherapy drugs used to treat triple negative breast cancer. Pegfilgrastim is a human granulocyte colony-stimulating factor (GCSF). It is given along with chemotherapy to reduce the risk of neutropenia (low white blood cell count) and infection.


This is a Phase II trial

Targeted Therapy Rebastinib With Carboplatin for Advanced Breast Cancer

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

Summary

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

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


This is a Phase I-II trial

DS-8201a for HER2-low Advanced Breast Cancer (DESTINY)

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

Summary

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

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

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

Summary

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

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


This is a Phase II trial

Radiation Therapy With or Without Olaparib For Inflammatory Breast Cancer

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

Summary

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

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


This is a Phase II trial

T-DM1 and Palbociclib for Advanced HER2 Positive Breast Cancer

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

Summary

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

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


This is a Phase II trial

Immunotherapy Galinpepimut-S and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers (NCT03761914)

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 not responded to other treatment options.

This study is assessing the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®). Galinpepimut-S is a vaccine that targets the protein WT1. Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

CAR T-Cell Therapy For Metastatic ROR1 Positive Triple Negative Breast Cancer

Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor (NCT02706392)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options and that tests positive for ROR1.

This study is assessing the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy being used in this study trains the immune system to attack ROR1-positive tumor cells. It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. This study is also enrolling patients with other types of ROR1-positive metastatic tumors.


This is a Phase I trial

CSF to Prevent Neutropenia (Infection) Caused by Chemotherapy (TrACER)

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as a Prophylaxis for Patients Receiving Chemotherapy With Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)(NCT02728596)

Summary

To take part in this study you must be receiving chemotherapy as part of your breast cancer treatment and have an intermediate risk of developing neutropenia (a low-white blood cell count).

This study is evaluating the benefits of using guidelines that have been developed to direct specific patients who are receiving certain types of chemotherapy to receive CSF to reduce their risk of neutropenia. Patients who develop neutropenia--a fever and low white cell blood count--are at increased risk of developing an infection. CSF (Colony-stimulating factors) are medications sometimes given to patients receiving chemotherapy to prevent neutropenia. This study is also enrolling patients with other types of cancer.

Syndros to Reduce Pain from Bone Metastases in Stage IV Breast Cancer

Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer (NCT03661892)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that has spread to the bone and have been taking an opioid for bone pain for at least 4 weeks.

This study will identify the best dose and side effects (good or bad) of Syndros (dronabinol) when used to treat pain from bone metastasis. Syndros is an FDA-approved cannabinoid. Cannabinoids are the active chemicals in medical marijuana. Syndros is approved to treat patients receiving chemotherapy whose nausea and vomiting are not controlled by other anti-nausea therapies.