This study investigates whether adding investigational medications to a treatment regimen can improve progression-free survival in patients with advanced HER2-positive breast cancer. HER2-positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2, which promotes the growth of cancer cells. The study will compare the effects of adding an investigational medication to a combination of trastuzumab and vinorelbine against using trastuzumab and vinorelbine alone.
Participants will be divided into different study arms. One arm will receive a combination of investigational medications along with trastuzumab and vinorelbine, while another arm will receive trastuzumab and vinorelbine without the additional investigational medications. The study will monitor progression-free survival, which is the length of time during and after treatment that the patient lives with the disease without it getting worse.
- Who can participate: Adults aged 18 years and older with breast cancer that is metastatic or unresectable loco-regionally advanced may participate. Key eligibility factors include no prior therapy with vinorelbine or certain other therapies, no active infections, and no significant cardiac or autoimmune diseases.
- Study details: Participants will be assigned to different study arms to receive either the investigational medication along with trastuzumab and vinorelbine or the standard treatment without the investigational medication. A placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine, may be used in some study arms.
