Abstract
Background With the significant improvement of the cure rate and survival rate of cancer patients, the survivors need to face quality of life problems, such as significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in the course of cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most potential drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. The optional trial is aimed to test whether administration of metformin during chemotherapy could protect normal ovarian function of early breast cancer patients. Methods This study is prospective, randomized, double-blind and placebo-controlled. Female early breast cancer patients (N=314), were randomly assigned to two groups (placebo, metformin 2000 mg). Metformin was administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome was the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients were followed up for 5 years to observe long-term ovarian function and prognosis of tumor, such as overall survival (OS), objective response rate (ORR), disease-free survival (DFS). Quality of life and safety will also be assessed. Discussion Our research will provide new treatment strategy of fertility protection, and clinical treatment guidance for cancer patients.
122MO Quality of life from the Penelope-B study on high-risk HR+/HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib
