This phase 1b/2 trial will investigate the safety of treatment with rucaparib (Rubraca) in combination with other anti-cancer agents (ACAs) in patients with triple-negative breast cancer and other solid tumors.
The main outcomes will be the number of treatment-related side effects and response to treatment. This trial is recruiting at a number of locations in the US.
Breast cancer (BC) is the most common cancer in women. In advanced BC, standard chemotherapy may not be enough to fight the disease. New drugs are in development to treat advanced cancer. Rucaparib is a drug that blocks an enzyme called PARP. Cancer cells use PARP to rapidly divide and grow. Blocking PARP slows tumor growth. Rucaparib is currently used to treat an aggressive form of ovarian cancer. Rucaparib may also be effective in other cancers. It is unclear if rucaparib can be safely combined with other anti-cancer agents (ACAs).
This trial will investigate the safety of treatment with rucaparib in combination with other ACAs. The main outcomes will be the number of side effects and response to treatment.
Who are they looking for?
This trial will recruit 329 patients with advanced cancer including triple-negative BC (TNBC). Patients must have adequate organ function and a tumor sample for genetic tests.
Patients cannot take part if they have a history of myelodysplastic syndrome (MDS; a form of cancer of the bone marrow). Patients with TNBC cannot have been previously treated with a PARP inhibitor. Patients with brain tumors cannot take part in the trial.
How will it work
There are 2 phases to this trial. In the first phase, patients will be treated with rucaparib and either lucitanib or sacituzumab govitecan (STZ-GVC). If treatment is well tolerated, patients will move on to the second phase. In this phase, treatment will continue for up to 2 years.
The main outcomes will be the number of side effects at 28 days and tumor response for up to 2 years.