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New Trials

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

Chemotherapy, Her2 Targeted Therapy & Immunotherapy Before Surgery in HER2+ Breast Cancer

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) (NCT03747120)

Summary

To take part in this study you must have HER2 positive stage I, II or III breast cancer and have not yet received any treatment for your breast cancer.

This study will compare the safety and effects (good or bad) of three different breast cancer treatment regimens that will be given before breast cancer surgery. The drugs used in different combinations in the treatment regimens are the HER2-targeted therapy trastuzumab (Herceptin®); the HER2-targeted therapy pertuzumab (Perjeta®); the immunotherapy pembrolizumab (Keytruda®); and the chemotherapy drug paclitaxel (Taxol®).


This is a Phase II trial

Keytruda with Taxol or Xeloda for Advanced Triple Negative Breast Cancer

A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT02734290)

Summary

This study is looking at the safety and effectiveness of using an immunotherapy drug along with a chemotherapy drug to treat breast cancer that cannot be removed by surgery. The immunotherapy drug is pembrolizumab (Keytruda®). It gets the body's immune system to go after cancer cells. The chemotherapy drug will be paclitaxel (Taxol®) or capacitabine (Xeloda®), depending on which group you are put in. Both drugs are commonly used to treat advanced breast cancer. To take part in this study, you must have advanced triple negative breast cancer.


This is a Phase I-II trial

SBRT Radiation Therapy for Patients With Oligoprogressive Metastatic Breast Cancer

A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease (NCT03808662)

Summary

To take part in this study you must have oligoprogessive metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has progressed on at least one other systemic treatment.

Patients with oligoprogressive metastatic breast cancer have a small number of metastatic tumors in one or two other parts of the body. This study will compare the safety and effects (good or bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases followed by a standard of care treatment to a standard of care treatment alone. SBRT uses multiple radiation beams to deliver high doses of precision radiation directly to the tumor.


This is a Phase II trial

  • Participation Time1 visit every other day for 6 or 10 days, then coincides with standard treatment
  • Participating research sites
    Research sites: 8 sites total

PF-06804103 in HER2+ Advanced Breast Cancer

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS (NCT03284723)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) HER2+ breast cancer and have no standard treatment options available. This study is investigating the safety and effect (good or bad) of PF-06804103. This investigational therapy is an antibody drug conjugate. It uses a HER2-targeted agent to deliver the chemotherapy drug Auristatin-0101 directly to HER2+ cancer cells. This study is also enrolling patients with other types of HER2+ solid tumors.
This is a Phase I trial

Oral TTI-101 in Patients with Advanced Breast Cancer

Phase I Study of TTI-101, an Oral Inhibitor of Signal Transducer and Activator of Transcription (STAT) 3, in Patients With Advanced Cancers (NCT03195699)

Summary

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

This study is evaluating the safety, effects (good or bad), and best dose of TT1-101, a new oral cancer drug. TTI-101 is a tyrosine-kinase inhibitor that blocks STAT3, a protein that helps cancer cells grow. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I trial

A Study of CDX-1140 as Monotherapy or in Combination in Pati...

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies (NCT03329950)

Summary

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

This study is testing the safety, effects (good or bad) and best dose of the experimental cancer drug CDX-1140 when it is used alone or in combination with CDX-301, which is also an experimental cancer drug. CDX-1140 targets a protein called CD40, which is found on cancer cells. CDX-301 is a new type of tyrosine-kinase inhibitor. It is also a targeted therapy. This study is enrolling patients with other types of solid tumors.


This is a Phase I trial

Radiation Therapy, Palbociclib & Hormone Therapy for Breast Cancer Related Bone Metastases

A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients (NCT03691493)

Summary

To take part in this study you must have estrogen receptor positive, HER2 negative metastatic (stage IV) breast cancer that has spread to the bone.

This study will investigate the effects (good or bad) of using radiation therapy along with the targeted therapy palbociclib (Ibrance®) and hormone therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Ibrance is a type of targeted therapy called a CDK 4/6 inhibitor. It is used along with a hormone therapy to treat metastatic breast cancer. The hormone therapies used along with Ibrance are fulvestrant (Faslodex®), letrozole (Femara®), anastrozole (Arimidex®), exemestane (Aromasin®) and tamoxifen.


This is a Phase II trial

Immunotherapy for Women with Breast Cancer-Related Leptomeningeal Metastases

A Phase I Study of Anti-CD3 x Anti-Her2/Neu (Her2Bi) Armed Activated T Cells (ATC) in Patients With Breast Cancer Leptomeningeal Metastases (NCT03661424)

Summary

To take part in this study you must be a woman with stage IV metastatic breast cancer that has spread to the membranes surrounding the brain and spinal cord. This is called leptomeningeal metastasis. This study is investigating the safety and effect (good or bad) of an experimental immunotherapy made out of T cells that have been activated to go after cancer cells. The treatment is called HER2 BATs. BATs is short for bi-specific antibody. Although trastuzumab (Herceptin®) is used to make the BATs, women do not need to have HER2+ breast cancer to take part in the study.
This is a Phase I trial

Vaccine Plus Chemotherapy Before Surgery in Triple Negative Breast Cancer

A Combined Phase II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE ISA 51 VG Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (NCT02938442)

Summary

To take part in this study you must be a woman with stage II or III triple negative breast cancer (ER-, PR- and HER2-) who is going to be treated with standard chemotherapy before surgery.

This study is comparing the safety and effects of an investigational vaccine along with chemotherapy to chemotherapy alone when given before surgery (neoadjuvant therapy). The vaccine, P10s-PADRE, is a peptide-based vaccine that is designed to enhance the immune response and potentially attack tumors. It is given along with Montanide ISA 51 VG, which is designed to enhance an immune response by stimulating cytotoxic T-lymphocytes.


This is a Phase II trial