Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03874325
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.
  • Anastrozole 1mg — DRUG
    Participants will self administer 1 mg anastrozole by mouth daily for 6 months.
  • Letrozole 2.5mg — DRUG
    Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.
  • Exemestane 25 MG — DRUG
    Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Study Details

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.

Key Dates

Start date
Apr 26, 2019
Status verified
May 2022
Primary completion
Nov 15, 2020
Completion
Jan 6, 2021

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run In: Durvalumab + Aromatase Inhibitor
    Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.
  • Experimental: Expansion: Durvalumab + Aromatase Inhibitor
    Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited.

Primary Outcome Measure

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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