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New Trials

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

AZD9833 With or Without Palbociclib in ER Positive and HER2 Negative Advanced Breast Cancer

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib in Women With ER Positive, HER2 Negative Advanced Breast Cancer(NCT03616587)

Summary

To take part in this study, you must have ER positive and HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies and, if metastatic, has not been treated with more than two different chemotherapy regimens.

This study will evaluate the safety and effect (good or bad) of AZD9833 alone or in combination with palbociclib (Ibrance®). AZD9833 is an experimental drug that targets the estrogen receptor and is being developed to treat ER positive, HER2 negative breast cancer. Ibrance is a targeted drug used to treat metastatic breast cancer. If you are premenopausal, you will also receive a drug that will put you in temporary menopause.


This is a Phase I trial

EDO-S101 in Patients With Advanced Triple Negative Breast Cancer

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of EDO-S101, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients With Advanced Solid Tumors (NCT03345485)

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 progressed following at least one line of therapy and have no other standard treatment options available.

This study is evaluating the safety and effects (good or bad) of tinostamustine (EDO-S101), a type of investigational targeted therapy called an HDAC inhibitor. HDACs are proteins that help cancer cells divide. They also help tumors become resistant to treatment. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I-II trial

Palbociclib, Letrozole and T-DM1 in ER Positive and HER2 Positive Metastatic Breast Cancer

A Phase I/II Study of Palbociclib, Letrozole and T-DM1 in Trastuzumab Refractory Estrogen Receptor Positive (ER+) and HER2 Positive Metastatic Breast Cancer(NCT03709082)

Summary

To take part in this study, you must have ER positive and HER2 positive metastatic (stage IV) breast cancer and have been treated with a taxane and trastuzumab (Herceptin).

This study will determine the best dose of palbociclib (Ibrance®) to use when it is given along with letrozole (Femara®) and T-DM1 (Kadcyla®). Ibrance is a type of targeted therapy called a CDK 4/6 inhibitor. It is used along with certain hormonal therapies to treat ER positive and HER2 negative metastatic breast cancer. Femara is an aromatase inhibitor used to treat hormone-sensitive tumors in postmenopausal women. Kadcyla is used to treat HER2-positive metastatic breast cancer. It combines the chemotherapy drug DM1 with the HER2-targeted drug trastuzumab (Herceptin®).


This is a Phase I-II trial

MK-1454 and Keytruda for Patients With Advanced Breast Cancer

Phase 1 Open Label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas (NCT03010176)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer and have a tumor that has not responded to, or has stopped responding to, other treatments.

This study will determine the best dose and safety of MK-1454, an immunotherapy drug that earlier studies suggest may make tumors more likely to respond to pembrolizumab (Keytruda®). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved to treat certain types of cancer, but not breast cancer. This study also is enrolling patients with other types of cancer.


This is a Phase I trial

Immunotherapy Plus Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies (NCT03719326)

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 progressed on or not responded to available therapies.

This study will evaluate the best dose, safety and effects (good or bad) of AB928 when it is used along with pegylated liposomal doxorubicin (PLD) to treat advanced triple-negative breast cancer. AB928 is a targeted therapy that researchers think can boost the immune system. Pegylated liposomal doxorubicin (Doxil®) is a chemotherapy drug used to treat breast cancer.


This is a Phase I trial