Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Exemestane

Letrozole

Durvalumab

Anastrozole

Aromatase Inhibitors

Antineoplastic Agents, Immunological

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

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.

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.

1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Anastrozole 1mg

Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Letrozole 2.5mg

Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Exemestane 25 MG

Hung Khong, MD

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.

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer

Modified preoperative endocrine prognostic index (mPEPI) of 0. Total PEPI score assigned to each patient is the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage, Ki67 level, and estrogen receptor (ER) status of the surgical specimen. A hazard ratio (HR) in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points.

mPEPI score of 0 indicates a tumor size of 5 cm or less, negative lymph nodes, and Ki67 (proliferation index) of less than or equal to 2.7%. Drug combination will be determined to be efficacious if 7 or more participants achieve an mPEPI of 0.

Clinical Complete response: Palpable lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.

Clinical Partial response: A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.

AstraZeneca

H. Lee Moffitt Cancer Center and Research Institute

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.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Safety Run In: Durvalumab + Aromatase Inhibitor

Study terminated early and did not move beyond safety run in.

Participants administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants took 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.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated early and did not go beyond Safety run in

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0

Clinical Complete Response (CR)

Clinical Partial Response (PR)

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.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Spots Global Cancer Trial Database for Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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