Trial Outcomes & Findings for Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer (NCT NCT01048099)
NCT ID: NCT01048099
Last Updated: 2016-01-29
Results Overview
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.
COMPLETED
NA
283 participants
18 months
2016-01-29
Participant Flow
Pts with HER2-negative, metastatic breast cancer were enrolled. Blood was collected to perform the PRO Onc Circulating Tumor Cell (CTC). Pts without CTCs present were taken off-study. Following the assay, pts without detected HER2 overexpression/activation were taken off-study. Of the remaining pts, those FISH-positive for HER2 came off-study.
Participant milestones
| Measure |
All Patients
|
|---|---|
|
Patients Enrolled and Blood Collected
STARTED
|
283
|
|
Patients Enrolled and Blood Collected
COMPLETED
|
226
|
|
Patients Enrolled and Blood Collected
NOT COMPLETED
|
57
|
|
Patients Evaluated by PRO Onc Assay
STARTED
|
226
|
|
Patients Evaluated by PRO Onc Assay
COMPLETED
|
24
|
|
Patients Evaluated by PRO Onc Assay
NOT COMPLETED
|
202
|
|
Pts w/ HER2 Overexpression/Activation
STARTED
|
24
|
|
Pts w/ HER2 Overexpression/Activation
COMPLETED
|
14
|
|
Pts w/ HER2 Overexpression/Activation
NOT COMPLETED
|
10
|
|
Treatment Per Protocol
STARTED
|
14
|
|
Treatment Per Protocol
COMPLETED
|
0
|
|
Treatment Per Protocol
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
All Patients
|
|---|---|
|
Patients Enrolled and Blood Collected
Patients without circulating tumor cells
|
57
|
|
Patients Evaluated by PRO Onc Assay
Patients with no HER2 abnormality
|
202
|
Baseline Characteristics
Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Patients Treated
n=14 Participants
Patients who received study treatment
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThe 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.
Outcome measures
| Measure |
All Patients Evaluated by PRO Onc Assay
n=14 Participants
|
|---|---|
|
Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)
|
7 percentage of participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Includes patients with HER2 overexpression detected by the PRO Onc Assay
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.
Outcome measures
| Measure |
All Patients Evaluated by PRO Onc Assay
n=10 Participants
|
|---|---|
|
Part II: Objective Response Rate of Trastuzumab Therapy
|
10 percentage of participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Includes patients with only HER2 activation (no overexpression) as detected by the PRO Onc Assay
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.
Outcome measures
| Measure |
All Patients Evaluated by PRO Onc Assay
n=4 Participants
|
|---|---|
|
Part II: Objective Response Rate of Pertuzumab Therapy
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsIncludes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.
Outcome measures
| Measure |
All Patients Evaluated by PRO Onc Assay
n=226 Participants
|
|---|---|
|
Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay
HER2 overexpressed
|
11 participants
|
|
Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay
HER2 activated
|
10 participants
|
|
Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay
HER2 overexpressed and activated
|
3 participants
|
|
Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay
No HER2 overexpression/activation detected
|
202 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Includes all patients with blood drawn and analyzed for CTCs
Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.
Outcome measures
| Measure |
All Patients Evaluated by PRO Onc Assay
n=283 Participants
|
|---|---|
|
Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens
|
80 percentage of participants
|
Adverse Events
All Treated Patients
Serious adverse events
| Measure |
All Treated Patients
n=14 participants at risk
Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
|
|---|---|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
14.3%
2/14 • Number of events 2 • 18 Months
|
|
Gastrointestinal disorders
Ileus
|
7.1%
1/14 • Number of events 1 • 18 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
7.1%
1/14 • Number of events 2 • 18 Months
|
Other adverse events
| Measure |
All Treated Patients
n=14 participants at risk
Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
|
|---|---|
|
General disorders
Fatigue
|
50.0%
7/14 • 18 Months
|
|
General disorders
Infusion related reaction
|
28.6%
4/14 • 18 Months
|
|
Infections and infestations
Urinary Tract Infection
|
28.6%
4/14 • 18 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • 18 Months
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • 18 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • 18 Months
|
|
Immune system disorders
Allergic reaction
|
14.3%
2/14 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • 18 Months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
2/14 • 18 Months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • 18 Months
|
|
General disorders
Edema
|
14.3%
2/14 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • 18 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • 18 Months
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • 18 Months
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • 18 Months
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • 18 Months
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • 18 Months
|
|
General disorders
Fever
|
7.1%
1/14 • 18 Months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 18 Months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, hydronephrosis
|
7.1%
1/14 • 18 Months
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
1/14 • 18 Months
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • 18 Months
|
|
Gastrointestinal disorders
Ileus
|
7.1%
1/14 • 18 Months
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • 18 Months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, liver dysfunction
|
7.1%
1/14 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • 18 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
1/14 • 18 Months
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • 18 Months
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, thoracic pain
|
7.1%
1/14 • 18 Months
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • 18 Months
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • 18 Months
|
|
Investigations
Weight loss
|
7.1%
1/14 • 18 Months
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER