This phase 3 trial will investigate the effectiveness of a new drug, DS-8201a, in the treatment of unresectable/metastatic breast cancer (UMBC). The main outcome will be survival without cancer worsening.
Breast cancer (BC) originates from tissue in the breast. BC is treated with surgery to remove the cancer or chemotherapy to kill it. In some cases, it may not be possible to surgically remove cancer cells. The term to describe this is ‘unresectable’. In other cases, cancer cells may travel to other organs via the lymph nodes. Once this occurs the cancer is called metastatic cancer. There are limited treatment options for patients with unresectable or metastatic breast cancer (UMBC).
New drugs are in development to treat cancers with poor prognosis. Antibody-drug conjugates (ADCs) are one of these. ADCs have two components – an antibody (Ab) and a drug. The Ab targets a specific protein in the cancer cells. A drug is attached (or conjugated) to the Ab. When the Ab binds the protein, the drug kills the cancer cell. ADCs are more specific than classic cancer drugs. There may also be fewer side effects with these drugs. DS-8201a is an ADC for UMBC treatment. TheAb (trastuzumab) attaches to a protein called HER2 on cancer cells. The drug (DM1) then kills the cell.
This trial will investigate the effectiveness of DS-8201a in the treatment of UMBC. The main outcome will be survival without cancer worsening.
Who are they looking for?
This trial will recruit 600 patients with HER2-positive cancer. The cancer must be unresectable or metastatic. Patients taking part in the trial must agree to use highly effective forms of contraception or avoid intercourse during the study and for up to 7 months after the last treatment dose. This applies to participants and sexual partners of the participants.
Patients with uncontrolled heart or lung disease cannot take part in the trial. Patients cannot have been treated with other ADCs by the sponsor.
How will it work
Patients will be assigned to one of 3 groups. One group will receive DS-8201a. This will be administered intravenously. Patients in the other groups will undergo standard therapy for UMBC. One group will receive capecitabine and trastuzumab. Another group will receive lapatinib and capecitabine. The study will last up to 45 months.
The main outcome will be survival without cancer worsening.