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Breast CancerNCT01048099

Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer

A study testing PRO Onc Assay and Treatment, Trastuzumab and Pertuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2 overexpression/activation by the PRO Onc Assay. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
PRO Onc Assay and Treatment, Trastuzumab and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
7 sitesUnited States
Study dates
Jan 2011to Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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/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.

Who cannot join

  • 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.
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  • Patients with New York Heart Association class II or greater congestive heart failure.
  • 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.
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

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

This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2 overexpression/activation by the PRO Onc Assay.

Read the detailed description

This two-part trial is designed to evaluate the clinical significance of the PRO Onc assay when used in patients with metastatic HER2-negative breast cancer. The first part of this study will determine the incidence of HER overexpression/activation, as determined by the PRO Onc assay, in patients previously judged to have HER2-negative breast cancer by FISH analysis. Blood specimens will be obtained from patients with HER2-negative breast cancer; CTCs will then be isolated and tested for HER2 overexpression/activation using the PRO Onc Assay. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay. If the incidence of HER2 overexpression/activation, as determined by the PRO Onc Assay, is >10%, the study will proceed to Part 2. Part 2 of this study will assess the efficacy of HER2-targeted therapy in a group of patients with HER2-negative breast cancer who are identified as having HER2 overexpression/activation by the PRO Onc Assay. Patients will be treated with either trastuzumab or pertuzumab. Patients who progress during the first 8 weeks will have HER2-targeted treatment discontinued and will be removed from study. After 8 weeks, patients who have stable disease will be allowed to add chemotherapy to HER2-targeted therapy. Patients who have an objective response to single-agent, HER2-targeted therapy after 8 weeks will continue single-agent therapy.

Conditions
Breast Cancer
Being tested
PRO Onc Assay and Treatment, Trastuzumab, Pertuzumab
Keywords
Breast Cancer, Metastatic, PRO Onc Assay, FISH Testing, HER Negative, HER Overexpression, HER Activation
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO Onc Assay and TreatmentProcedure or surgery

    Also called blood draw, fine needle aspiration, circulating tumor cells

    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.

  • TrastuzumabDrug

    Also called Herceptin

    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

  • PertuzumabDrug

    Also called Perjeta

    840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks

Study groups in NCT01048099
Study groupRoleWhat they receive
PRO Onc Assay and TreatmentExperimentalBlood specimens tested for circulating tumor cells followed by systemic treatment based on assay results with either trastuzumab or pertuzumab
Receives: Procedure: PRO Onc Assay and Treatment; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)

    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.

    Measured: 18 months

  2. Part II: Objective Response Rate of Trastuzumab Therapy

    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.

    Measured: 18 months

  3. Part II: Objective Response Rate of Pertuzumab Therapy

    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.

    Measured: 18 months

Secondary outcomes (2)

  1. Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay

    Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.

    Measured: 12 months

  2. Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens

    Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01048099
Sponsor's protocol ID
SCRI BRE 166
Status last verified
Dec 2015
First submitted
12 Jan 2010
Last updated
29 Jan 2016
Data monitoring committee
No

Publications

  • Hainsworth JD, Murphy PB, Alemar JR, Daniel BR, Young RR, Yardley DA. Use of a multiplexed immunoassay (PRO Onc assay) to detect HER2 abnormalities in circulating tumor cells of women with HER2-negative metastatic breast cancer: lack of response to HER2-targeted therapy. Breast Cancer Res Treat. 2016 Nov;160(1):41-49. doi: 10.1007/s10549-016-3969-7. Epub 2016 Sep 8.

    PubMed 27632289

Questions about this trial

What is this clinical trial studying?

A study testing PRO Onc Assay and Treatment, Trastuzumab and Pertuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01048099, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.

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