Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01048099 |
Recruitment Status
:
Completed
First Posted
: January 13, 2010
Results First Posted
: January 29, 2016
Last Update Posted
: January 29, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Procedure: PRO Onc Assay and Treatment Drug: Trastuzumab Drug: Pertuzumab | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 283 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of the PRO Onc Assay to Assess HER2 Overexpression and Activation in Patients With Metastatic Breast Cancer Whose Tumors Are HER2-Negative by Standard FISH Testing |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: PRO Onc Assay and Treatment
Blood specimens tested for circulating tumor cells followed by systemic treatment based on assay results with either trastuzumab or pertuzumab
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Procedure: PRO Onc Assay and Treatment
Patients with HER2-negative metastatic breast cancer will be identified, and blood specimens will be obtained from each participant. The PRO Onc Assay will be performed on CTCs isolated from these specimens. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay.
Other Names:
Drug: Trastuzumab
8 mg/kg IV loading dose, followed by 6 mg /kg IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
Other Name: Herceptin
Drug: Pertuzumab
840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
Other Name: Perjeta
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- Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing) [ Time Frame: 18 months ]The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.
- Part II: Objective Response Rate of Trastuzumab Therapy [ Time Frame: 18 months ]The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression as identified by the PRO Onc Assay.
- Part II: Objective Response Rate of Pertuzumab Therapy [ Time Frame: 18 months ]The percentage of patients with HER2 activation (no overexpression) as identified by the PRO Onc Assay who experience an objective benefit from treatment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay [ Time Frame: 12 months ]Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.
- Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens [ Time Frame: 12 months ]Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part I
- Women with HER2-negative breast cancer, as defined by FISH testing. (FISH testing may have been performed on the primary tumor, or subsequently on a biopsy of a metastatic lesion.)
- Patients should be currently receiving chemotherapy, or scheduled to start chemotherapy (second-line or subsequent), for HER2-negative metastatic breast cancer.
- To begin protocol treatment, patients must have progressed after at least 1 previous chemotherapy regimen for metastatic breast cancer.
- Patients who are ER/PR positive or negative are eligible. ER/PR positive patients should be refractory to hormonal therapy, or not good candidates for hormonal therapy due to clinical features.
- ECOG performance status of 0, 1 or 2.
- Adequate recovery from recent surgery; ≥ 1 week must have elapsed from the time of a minor surgery; ≥ 4 weeks must have elapsed from the time of a major surgery.
- Patients must have measurable disease per RECIST criteria.
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Laboratory values as follows: Absolute neutrophil count (ANC) ≥1500/μL Hemoglobin (Hgb) ≥10 g/dL Platelets ≥100,000/L AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases. Total bilirubin <1.5 x the institutional ULN Serum creatinine <1.5 x institutional ULN or calculated creatinine clearance ≥45 mL/min
Patients from Part 1 who have HER2 overexpression/activation identified by the PRO Onc Assay may enter the treatment portion of Part 2, if they meet all Part 2 eligibility criteria.
- Life expectancy of ≥ 12 weeks.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Part II
- Women with HER2-negative breast cancer, as defined by FISH testing. (FISH testing may have been performed on the primary tumor, or subsequently on a biopsy of a metastatic lesion.)
- Patients should be currently receiving chemotherapy, or scheduled to start chemotherapy, for HER2-negative metastatic breast cancer.
- Patients who are ER/PR positive or negative are eligible. ER/PR positive patients should be refractory to hormonal therapy, or not good candidates for hormonal therapy due to clinical features.
- ECOG performance status of 0, 1 or 2.
- Adequate recovery from recent surgery; ≥ 1 week must have elapsed from the time of a minor surgery; ≥ 4 weeks must have elapsed from the time of a major surgery.
- Patients must have measurable disease per RECIST criteria.
-
Laboratory values as follows:
- Absolute neutrophil count (ANC) ≥1500/μL
- Hemoglobin (Hgb) ≥10 g/dL
- Platelets ≥100,000/uL
- AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases.
- Total bilirubin <1.5 x the institutional ULN
- Serum creatinine <1.5 x institutional ULN or calculated creatinine clearance ≥45 mL/min
- Life expectancy of ≥ 12 weeks.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
- Patients who are eligible for HER2-targeted treatment will begin this treatment at the first time a treatment change is necessary (i.e. at the next progression of metastatic breast cancer). This may occur immediately after PRO Onc assay results are received, or may be several months later, for patients responding well to their current chemotherapy.
- Patients must continue to meet all inclusion and exclusion criteria for the Part 2 screening population at the time they are ready to start HER2-targeted treatment.
- Ejection fraction ≥ 50%, as measured by echocardiogram (ECHO) or MUGA.
Exclusion Criteria:
Part I:
- Patients currently responding to hormonal therapy.
- Previous treatment with any HER2-targeted agent.
- Patients with meningeal metastases.
- Patients who are not considered likely candidates for subsequent therapy after next progression of metastatic breast cancer.
- Women who are pregnant or lactating.
- Patients with New York Heart Association class II or greater congestive heart failure.
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Any of the following ≤6 months prior to starting study treatment:
- myocardial infarction;
- severe unstable angina;
- ongoing cardiac dysrhythmia
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
Part II
- Patients currently responding to hormonal therapy.
- Previous treatment with any HER2-targeted agent.
- Patients with meningeal metastases.
- Patients with active brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 4 weeks have elapsed since treatment. Ideally, patients should not still require use of seizure medication or steroids.
- Patients who are not considered likely candidates for subsequent therapy after next progression of metastatic breast cancer.
- Women who are pregnant or lactating.
- Patients with New York Heart Association class II or greater congestive heart failure.
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Any of the following ≤6 months prior to starting study treatment:
- myocardial infarction;
- severe unstable angina;
- ongoing cardiac dysrhythmia.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048099
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33916 | |
Florida Cancer Specialists | |
St. Petersburg, Florida, United States, 33705 | |
United States, Ohio | |
Oncology Hematology Care, Inc. | |
Cincinnati, Ohio, United States, 45242 | |
United States, Tennessee | |
Chattanooga Oncology Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 | |
United States, Texas | |
Center for Cancer and Blood Disorders | |
Fort Worth, Texas, United States, 76104 | |
United States, Virginia | |
Virginia Cancer Institute | |
Richmond, Virginia, United States, 23230 |
Study Chair: | John D. Hainsworth, M.D. | SCRI Development Innovations, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier: | NCT01048099 History of Changes |
Other Study ID Numbers: |
SCRI BRE 166 |
First Posted: | January 13, 2010 Key Record Dates |
Results First Posted: | January 29, 2016 |
Last Update Posted: | January 29, 2016 |
Last Verified: | December 2015 |
Keywords provided by SCRI Development Innovations, LLC:
Breast Cancer Metastatic PRO Onc Assay FISH Testing |
HER Negative HER Overexpression HER Activation |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Pertuzumab Trastuzumab Antineoplastic Agents |