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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01048099
• Date of registration: 12/01/2010
• Prospective Registration: Yes
• Primary sponsor: SCRI Development Innovations, LLC
• Public title: Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
• Scientific 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
• Date of first enrolment: January 2011
• Target sample size: 283
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01048099
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: John D. Hainsworth, M.D.
• Affiliation: SCRI Development Innovations, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

Part I

1. 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.)

2. Patients should be currently receiving chemotherapy, or scheduled to start
chemotherapy (second-line or subsequent), for HER2-negative metastatic breast cancer.

3. To begin protocol treatment, patients must have progressed after at least 1 previous
chemotherapy regimen for metastatic breast cancer.

4. 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.

5. ECOG performance status of 0, 1 or 2.

6. 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.

7. Patients must have measurable disease per RECIST criteria.

8. 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.

9. Life expectancy of = 12 weeks.

10. Patient must be accessible for treatment and follow-up.

11. Patients must be able to understand the investigational nature of this study and give
written informed consent prior to study entry.

Part II

1. 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.)

2. Patients should be currently receiving chemotherapy, or scheduled to start
chemotherapy, for HER2-negative metastatic breast cancer.

3. 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.

4. ECOG performance status of 0, 1 or 2.

5. 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.

6. Patients must have measurable disease per RECIST criteria.

7. 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

8. Life expectancy of = 12 weeks.

9. Patient must be accessible for treatment and follow-up.

10. Patients must be able to understand the investigational nature of this study and give
written informed consent prior to study entry.

11. 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.

12. 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.

13. Ejection fraction = 50%, as measured by echocardiogram (ECHO) or MUGA.

Exclusion Criteria:

Part I:

1. Patients currently responding to hormonal therapy.

2. Previous treatment with any HER2-targeted agent.

3. Patients with meningeal metastases.

4. Patients who are not considered likely candidates for subsequent therapy after next
progression of metastatic breast cancer.

5. Women who are pregnant or lactating.

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

7. Any of the following =6 months prior to starting study treatment:

- myocardial infarction;

- severe unstable angina;

- ongoing cardiac dysrhythmia

8. 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.

9. Mental condition that would prevent patient comprehension of the nature of, and risk
associated with, the study.

10. 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

1. Patients currently responding to hormonal therapy.

2. Previous treatment with any HER2-targeted agent.

3. Patients with meningeal metastases.

4. 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.

5. Patients who are not considered likely candidates for subsequent therapy after next
progression of metastatic breast cancer.

6. Women who are pregnant or lactating.

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

8. Any of the following =6 months prior to starting study treatment:

- myocardial infarction;

- severe unstable angina;

- ongoing cardiac dysrhythmia.

9. 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.

10. Mental condition that would prevent patient comprehension of the natur


Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Pertuzumab

Procedure: PRO Onc Assay and Treatment

Drug: Trastuzumab

Primary Outcome(s)

Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing) [Time Frame: 18 months]

Part II: Objective Response Rate of Pertuzumab Therapy [Time Frame: 18 months]

Part II: Objective Response Rate of Trastuzumab Therapy [Time Frame: 18 months]

Secondary Outcome(s)

Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens [Time Frame: 12 months]

Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay [Time Frame: 12 months]

Secondary ID(s)

SCRI BRE 166

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.

Prometheus Laboratories

Results

• Results available: Yes
• Date Posted: 29/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01048099