Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03132467
Brief Summary:
This early phase I trial studies the side effects of durvalumab and tremelimumab before surgery in treating patients with hormone receptor positive, HER2 negative stage II-III breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of enrolling patients with hormone receptor positive (HR+)/human epidermal growth factor receptor negative (HER2-) breast cancer onto a trial evaluating investigational agents prior to initiating standard neoadjuvant chemotherapy.
II. To evaluate the safety and tolerability of tremelimumab plus durvalumab in patients with HR+/HER2- breast cancer.
SECONDARY OBJECTIVES:
I. To assess immunologic/molecular responses to tremelimumab and durvalumab in patients with HR+/HER2- breast cancer who receive the combination therapy.
EXPLORATORY OBJECTIVES:
I. To evaluate the pathologic response in patients with HR+/HER2- breast cancer receiving tremelimumab plus durvalumab prior to initiating standard neoadjuvant chemotherapy.
OUTLINE:
Patients receive tremelimumab intravenously (IV) over 1 hour and durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo a biopsy and receive standard of care neoadjuvant chemotherapy before undergoing surgery.
After completion of study treatment, patients are followed up until the time of surgery.
Study:
NCT03132467
Study Brief:
Protocol Section:
NCT03132467