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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:August 15, 2017
End Date:September 2020
Contact:Tiffany Crowell
Email:tcrowell@merrimack.com
Phone:617-441-1000

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SHERBOC: A Double-blind, Placebo-controlled, Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer

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.

This study is a randomized, double-blind, placebo-controlled international phase 2 trial in
patients with HRG+, HR+, HER2- metastatic breast cancer that has progressed following
treatment with no more than 2 prior therapies, one of which must have been a CDK inhibitor.
All patients will be screened for heregulin using central testing, and eligible patients will
be randomized to receive either seribantumab + fulvestrant or placebo + fulvestrant. Disease
status will be assessed according to RECIST v 1.1 to support the primary endpoint.

Inclusion Criteria:

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.

1. Patients must have histologically or cytologically confirmed ER+ and/or PR+ (with
staining of >1% cells) breast cancer.

2. Patients with confirmed postmenopausal status due to either surgical/natural menopause
or ovarian suppression.

3. Patients must be HER2 negative.

4. Patient must have at least one lesion amenable to either core needle biopsy or fine
needle aspiration.

5. Patient must have a positive in-situ hybridization (ISH) test for heregulin, as
determined by centralized testing of unstained tumor tissue.

6. Patients that have progressed following at least one but no more than two prior
systemic therapies in the locally advanced or metastatic disease setting.

7. 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).

8. Patients with bone-only lesions who have received radiation to those lesions must have
documented progression following radiation therapy.

9. ECOG Performance Score (PS) of 0 or 1.

10. Patients with adequate bone marrow reserves.

11. Adequate hepatic function.

12. Adequate renal function.

13. Patient has recovered from clinically significant effects of any prior, surgery,
radiosurgery, or other antineoplastic therapy.

14. 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.

Exclusion Criteria:

Patients must meet all the inclusion criteria listed above and none of the following
exclusion criteria.

1. Prior treatment with an anti-ErbB3 antibody.

2. Prior treatment with a chemotherapy in the locally advanced or metastatic disease
setting.

3. Patients cannot have received prior treatment with fulvestrant or other SERDs in the
locally advanced or metastatic setting.

4. Uncontrolled CNS disease or presence of leptomeningeal disease.

5. Inflammatory breast cancer.

6. 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.

7. 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.

8. Known hypersensitivity to any of the components of seribantumab, fulvestrant, or who
have had hypersensitivity reactions to fully human monoclonal antibodies.

9. NYHA Class III or IV congestive heart failure.

10. 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.

11. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; or active
human immunodeficiency virus (HIV) infection, active hepatitis B infection or active
hepatitis C infection.
We found this trial at
23
sites
Columbus, Georgia 31904
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Beverly Hills, California 90211
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41 Burlington Mall Road
Burlington, Massachusetts 01805
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Burlington, MA
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Chandler, AZ
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28207
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Charlotte, NC
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Decatur, IL
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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1562 Oppossumtown Pike
Frederick, Maryland 21702
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Frederick, MD
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Grand Island, Nebraska 68803
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Grand Island, NE
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1 Auenbruggerplatz
Graz, 8036
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Graz,
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Jackson, Mississippi 39216
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Jackson, MS
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Miami, FL
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Orlando, FL
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Palo Alto, California 94304
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Palo Alto, CA
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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10 Woodland Rd
Saint Helena, California 94574
(707) 963-3611
Saint Helena Hospital Located in the beautiful Napa Valley, St. Helena Hospital remains committed to...
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Saint Helena, CA
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2000 Circle of Hope Drive
Salt Lake City, Utah 84112
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Silver Spring, Maryland 20902
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Silver Spring, MD
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1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
Mercy Hospital Springfield We're continuing a tradition of healing more than 120 years old. Mercy...
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Springfield, MO
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Stamford, Connecticut 06904
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Tampa, Florida 33612
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Tampa, FL
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