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Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT03874325•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Postmenopausal, defined as meeting criteria per protocol.
•Clinical T2-T4c, any N, MO by American Joint Committee on Cancer staging, 8th edition, with the goal being definitive surgery after completion of neoadjuvant therapy. Tumor is palpable and its size can be measured bidimensionally by tape, ruler or caliper technique. Largest tumor diameter over 2.0 cm.
•Pathologic confirmation of invasive breast cancer that is estrogen receptor (ER) positive as defined in the protocol.
•Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) negative as defined in the protocol protocol.
•Documentation of mammogram and ultrasound \[including ductal carcinoma in situ (DCIS) and invasive cancer\] of the diseased breast performed within 60 days prior to enrollment. Mammograms for the unaffected contralateral breast is required within 12 months prior to enrollment.
•Adequate organ and marrow function, as defined in the protocol.
•Participants must be willing to undergo a research biopsy at baseline and after one cycle of treatment and to provide tissue obtained at surgery for biomarker and correlative studies.
•Participants must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•If taking herbal or natural remedies that may have immune modulatory effects, participants must be willing to discontinue use prior to first dose of durvalumab.
+1 more criteria

Exclusion Criteria

•Participation in another clinical study with an investigational product during the last 4 weeks.
•Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow up period of an interventional study.
•Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
•An excisional biopsy of this breast cancer. Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
•Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
•Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
•Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
•History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥ 5 years or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ.
•History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or endocrine therapy or contralateral invasive breast cancer at any time.
•Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection); systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid; or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
+11 more criteria

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

April 26, 2019

Primary Completion Date

November 15, 2020

Completion Date

January 6, 2021

Last Updated

May 31, 2022

Enrollment

ACTUAL participants

Conditions

Breast CancerHormone Receptor Positive Tumor

Interventions

Durvalumab

DRUG

Anastrozole 1mg

DRUG

Letrozole 2.5mg

DRUG

Exemestane 25 MG

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 31, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

Inclusion Criteria

Exclusion Criteria

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