M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of M7824 in early stage breast cancer (stage II/III). II. To evaluate pathological response at the time of surg...
PRIMARY OBJECTIVE: I. To evaluate the change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of M7824 in early stage breast cancer (stage II/III). II. To evaluate pathological response at the time of surgery after 2 doses of M7824 followed by neoadjuvant (human epidermal growth factor receptor 2) HER2 targeted therapy in combination with chemotherapy of physician's choice. EXPLORATORY OBJECTIVES: I. To evaluate imaging based response to M7824. II. To evaluate potential systemic and tumor based predictive biomarker candidates of response. III. To evaluate immune responses induced by exposure to M7824 systemically and in tumor microenvironment (TME). OUTLINE: Patients receive anti-PD-L1/TGFbetaRII fusion protein M7824 intravenously (IV) over 1 hour on days 1 and 15. During days 28-56 patients receive planned neoadjuvant chemotherapy.
Tracking Information
- NCT #
- NCT03620201
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rashmi K Murthy M.D. Anderson Cancer Center
Get Well Soon