CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 16 enrolled
Drug / intervention
Durvalumab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Hormone receptor positive (ER and/or PR >10% by IHC) and HER2 negative breast cancer, clinically staged II–III with no metastatic disease
  • ✓ECOG performance status 0 or 1
  • ✓Chemotherapy is planned in the neoadjuvant setting
  • ✓Adequate bone marrow function: hemoglobin ≥9.0 g/dL, ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L
Key exclusion· 12
  • ✕Prior treatment with any PD-1, PD-L1 inhibitor (including durvalumab), or anti-CTLA-4 (including tremelimumab)
  • ✕Prior therapy for this current diagnosis of breast cancer, including endocrine or chemotherapy
  • ✕Prior malignancy within 5 years, except low-risk recurrence malignancies, non-melanoma skin cancer, or carcinoma in situ
  • ✕Active or prior autoimmune disease within 2 years (except vitiligo, Graves disease, or psoriasis not requiring systemic treatment)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03132467
NCT03132467Early Ph 1Completed
CompareCT.gov

A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab [MEDI4736]) Plus Anti-CTLA-4 Antibody (Tremelimumab) in Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer

M.D. Anderson Cancer Center·interventional·Posted Apr 27, 2017·Updated Jun 5, 2024

In Brief

A Early Phase 1 clinical trial evaluating Durvalumab and Tremelimumab for Anatomic Stage II Breast Cancer AJCC v8 and 16 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA 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, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive, 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, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartJun 13, 2017
Primary CompletionJan 31, 2019
Study CompletionMay 20, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.2 years ago

Interventions

Durvalumabbiological

Given IV

Tremelimumabbiological

Given IV