A clinical trial looking at denosumab (Xgeva) as adjuvant treatment for women with early-stage breast cancer who are at high risk of recurrence is being conducted worldwide. The study is recruiting participants affected by Stage II or Stage III breast cancer.
Denosumab was recently approved by the Food and Drug Administration to help prevent bone damage in people with bone metastases, or cancer that has traveled to the bone. For women with early-stage breast cancer, bone is a frequent site of relapse, and the purpose of this randomized, Phase III trial is to determine whether denosumab is effective in preventing recurrence in the bone or any other part of the body when it is given in early-stage breast cancer.
Over about six years, researchers will focus on measuring the period of metastases-free survival (MFS) for participants. They will also consider the period of disease-free survival (DFS), overall survival (OS) and distant recurrence-free survival (DRFS), as well as the safety and tolerability of denosumab. Metastases-free survival refers to the length of time that each participant remains free of detectable bone metastases. Disease-free survival means the period of time that participants remain free of any detectable recurrence of cancer at the primary site, the area where the cancer first appeared, and distant recurrence-free survival refers to the period of time that each participant remains free of any detectable cancer in an area that is not the primary site and is not in the bone.
Denosumab is a monoclonal antibody, a medicine that targets specific substances in the body and either interferes with or interrupts the action of that substance. Denosumab interferes with the protein RANKL, which is the body’s primary signal for breaking down bone.
About the Structure of the Trial
This trial will take place in 194 facilities worldwide. Participants will be arranged into two random groups. One group will receive the study treatment, a subcutaneous injection (under the skin) of denosumab once monthly for six months, then every three months for the next four-and-a-half years. The other group with receive the standard treatment, a placebo or sugar pill—a substance that does not have medicine—as a subcutaneous injection once monthly for six months, then every three months for the next four-and-a-half years. Both groups will also take calcium and vitamin D daily for five years.
Researchers will monitor the participants for changes, as well as side effects and possible safety issues.
Who Is Eligible for This Trial?
This trial seeks 4,500 participants who are age 18 years or older with a confirmed diagnosis of Stage II or Stage III breast cancer that has high risk of recurrence and shows no evidence of metastasis. Participants should be receiving or scheduled to receive chemotherapy, hormonal therapy or HER2 targeted therapy.
Women who have metastatic disease, or have had it in the past are not eligible for the trial, as are those with a past history of breast cancer. In addition, women with osteoporosis that requires treatment, who have used bisphosphonates, are pregnant or breastfeeding or who have serious dental problems may not participate.