Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.

Key facts

Study ID: NCT03241810
Run by: Elevation Oncology
People needed: 22
Starts: 2017-08-15
Expected to finish: 2018-11-30
Last updated by the study team: 2020-09-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

To be eligible for participation in the study, patients must meet the following criteria. Patients who are HRG negative do not need to complete screening procedures beyond HRG assessment.
Patients must have histologically or cytologically confirmed ER+ and/or PR+ (with staining of >1% cells) breast cancer.
Patients with confirmed postmenopausal status due to either surgical/natural menopause or ovarian suppression.
Patients must be HER2 negative.
Patient must have at least one lesion amenable to either core needle biopsy or fine needle aspiration.
Patient must have a positive in-situ hybridization (ISH) test for heregulin, as determined by centralized testing of unstained tumor tissue.
Patients that have progressed following at least one but no more than two prior systemic therapies in the locally advanced or metastatic disease setting.
Patients with documented progression of locally advanced or metastatic disease as defined by RECISTv1.1 (Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lytic lesions visible on a CT or MRI and have documented disease progression on prior therapy based on the appearance of new lesions).
Patients with bone-only lesions who have received radiation to those lesions must have documented progression following radiation therapy.
ECOG Performance Score (PS) of 0 or 1.
Patients with adequate bone marrow reserves.
Adequate hepatic function.
Adequate renal function.
Patient has recovered from clinically significant effects of any prior, surgery, radiosurgery, or other antineoplastic therapy.
Patients who have experienced a venous thromboembolic event within 60 days of signing the main consent form should have been treated with anti-coagulants for at least 7 days prior to beginning treatment and for the duration of treatment on this study.

You may not qualify if…

Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria.
Prior treatment with an anti-ErbB3 antibody.
Prior treatment with a chemotherapy in the locally advanced or metastatic disease setting.
Patients cannot have received prior treatment with fulvestrant or other SERDs in the locally advanced or metastatic setting.
Uncontrolled CNS disease or presence of leptomeningeal disease.
Inflammatory breast cancer.
History of another active malignancy that required systemic therapy in the last 2 years. Patients with prior history of in-situ cancer, basal, or squamous cell skin cancer are eligible.
Patients with an active infection, or unexplained fever > 38.5 C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patients participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled.
Known hypersensitivity to any of the components of seribantumab, fulvestrant, or who have had hypersensitivity reactions to fully human monoclonal antibodies.
NYHA Class III or IV congestive heart failure.
Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded.
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; or active human immunodeficiency virus (HIV) infection, active hepatitis B infection or active hepatitis C infection.

Where it is running

Highland Oncology Group — Fayetteville, Arkansas, United States
Beverly Hills Cancer Center — Beverly Hills, California, United States
Stanford University — Palo Alto, California, United States
Saint Helena Hospital — St. Helena, California, United States
Stamford Hospital — Stamford, Connecticut, United States
Sylvester Comprehensive Cancer Center — Miami, Florida, United States
UF Health Cancer Center at Orlando Health — Orlando, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Columbus Regional Research Institute — Columbus, Georgia, United States
Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
James M Stockman Cancer Institute — Frederick, Maryland, United States
Holy Cross Hospital Health Center — Silver Spring, Maryland, United States
Lahey Clinical Medical Center — Burlington, Massachusetts, United States
University of Mississippi — Jackson, Mississippi, United States
Mercy Hospital Springfield — Springfield, Missouri, United States
Saint Francis Cancer Treatment Center — Grand Island, Nebraska, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Oncology Specialists of Charlotte — Charlotte, North Carolina, United States
UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
University of Utah Health Care - Huntsman Cancer Institute — Salt Lake City, Utah, United States
LKH - Universitätsklinikum Graz — Graz, Austria
Universitaetsklinik fuer Gynaekologie und Geburtshilfe — Innsbruck, Austria
Krankenhaus der Barmherzigen Schwestern Linz — Linz, Austria
Ironwood Cancer and Research Centers- Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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