Breast CancerPhase 1PETRANCT01805908
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
A Phase 1 study testing 111In-Pertuzumab + SPECT-CT in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 2 sites in Canada.
Trial summary
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to… 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?
- 111In-Pertuzumab + SPECT-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2013to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Metastatic, locally recurrent (local recurrence not amenable to surgical resection of curative intent), or locally advanced (T3 or T4, any N, M0) adenocarcinoma of the breast.
- Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines
- Initiating treatment with TmAb
- Clinically measurable disease (by RECIST for patients with metastatic disease).
Who cannot join
- Male gender.
- Less than 18 years of age.
- Life expectancy < 12 weeks.
- Only site of metastases is liver.
- Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
- Currently receiving PmAb or lapatinib for treatment of MBC.
Show all 23Show fewer
- Having received TmAb as adjuvant therapy within the previous 6 months.
- Required to receive another radiopharmaceutical during the first week of the study.
- Hypersensitivity to monoclonal antibodies.
- Left Ventricular Ejection Fraction (LVEF) < 50% at baseline (within 42 days of study registration) as determined by either echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) scan.
- Hematology and/or biochemistry parameters outside acceptable ranges:
- absolute neutrophil count <1,500 cells/mm3,
- platelet count <100,000 cells/mm3,
- hemoglobin <9 g/dL,
- total bilirubin > upper limit of normal (ULN) (unless subject has documented Gilbert's Syndrome),
- aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase(SGOT)] and alanine aminotransferase (ALT) [serum glutamic pyruvate transaminase(SGPT)] >2.5 × ULN,
- serum creatinine >2.0 mg/dL or 177 μmol/L,
- alanine aminotransferase (ALP) >2.5 x ULN.
- Known pregnancy or lactating female (e.g. positive serum beta-human chorionic gonadotropin (B-hCG) pregnancy test).
- For women of childbearing potential, failure to agree to use a highly effective form of contraception (patient and/or partner, e.g., surgical sterilization) or two effective forms of contraception (a reliable barrier method in conjunction with spermicidal jelly, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment.
- Any condition, which in the investigator's opinion would not make the patient a suitable candidate for inclusion in the trial.
- Participation in another clinical trial.
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Cancer Centre
Hamilton, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario
About this study
Official title: Imaging With 111In-Pertuzumab to Predict Response to Trastuzumab in HER2 Positive Metastatic or Locally Advanced Breast Cancer
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.
- Conditions
- Breast Cancer
- Being tested
- 111In-Pertuzumab + SPECT-CT
- Keywords
- metastatic, breast cancer, herceptin, imaging, tumour response, adenocarcinoma, SPECT-CT, pertuzumab, trastuzumab, locally advanced
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
111In-Pertuzumab + SPECT-CTOther
111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.
| Study group | Role | What they receive |
|---|---|---|
| 111In-Pertuzumab + SPECT-CT | Experimental | Radiopharmaceutical 111In-labeled Pertuzumab given intravenously prior to SPECT-CT imaging. Receives: Other: 111In-Pertuzumab + SPECT-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Measured: 8 days
Safety attributable to 111In-Pertuzumab injections
The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
Measured: 3 months
Secondary outcomes (4)
Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured.
The pharmacokinetics of 111In-PmAb and tumour and normal tissue localization properties of 111In-PmAb will be measured. Standard PK parameters (t1/2 alpha, t1/2β, V1, Vss and CL) will be calculated.
Measured: 3 months
Optimal mass dose of 111In-PmAb
The dose of 111In-PmAb that is associated with the optimal SPECT-CT images will be established.
Measured: 3 months
Change in tumour SUV from Baseline to Day 36
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 36 (Day 36 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Measured: 3 months
Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Accrual is very poor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Levine, Principal investigator, Ontario Clinical Oncology Group, McMaster UniversityRaymond Reilly, Principal investigator, University of TorontoKathleen Pritchard, Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805908
- Sponsor's protocol ID
- OCOG-2011-PETRA
- Acronym
- PETRA
- Status last verified
- Jun 2016
- First submitted
- 12 Feb 2013
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam K, Chan C, Done SJ, Levine MN, Reilly RM. Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of (111)In-BzDTPA-pertuzumab. Nucl Med Biol. 2015 Feb;42(2):78-84. doi: 10.1016/j.nucmedbio.2014.09.011. Epub 2014 Oct 14.
PubMed 25459109
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging With 111In-Pertuzumab to Predict Response to Trastuzumab in HER2 Positive Metastatic or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01805908
- Acronym / sponsor ID
- PETRA / OCOG-2011-PETRA
- Conditions
- Breast Cancer
- Keywords
- metastatic, breast cancer, herceptin, imaging, tumour response, adenocarcinoma, SPECT-CT, pertuzumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual is very poor
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 111In-Pertuzumab + SPECT-CT | Experimental | Other: 111In-Pertuzumab + SPECT-CTRadiopharmaceutical 111In-labeled Pertuzumab given intravenously prior to SPECT-CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metastatic, locally recurrent (local recurrence not amenable to surgical resection of curative intent), or locally advanced (T3 or T4, any N, M0) adenocarcinoma of the breast.
- Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines
- Initiating treatment with TmAb
- Clinically measurable disease (by RECIST for patients with metastatic disease).
Key exclusion criteria (23 listed)
- Male gender.
- Less than 18 years of age.
- Life expectancy < 12 weeks.
- Only site of metastases is liver.
- Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 111In-Pertuzumab + SPECT-CT111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory. | Other | 111In-Pertuzumab + SPECT-CT |
Primary outcome
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
Time frame: 8 days
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Safety attributable to 111In-Pertuzumab injections
Time frame: 3 months
The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
4 secondary outcomes
Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured.
Time frame: 3 months
Optimal mass dose of 111In-PmAb
Time frame: 3 months
Change in tumour SUV from Baseline to Day 36
Time frame: 3 months
Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Accrual is very poor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Derived from this study: PubMed 25459109Lam K, Chan C, Done SJ, Levine MN, Reilly RM. Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of (111)In-BzDTPA-pertuzumab. Nucl Med Biol. 2015 Feb;42(2):78-84. doi: 10.1016/j.nucmedbio.2014.09.011. Epub 2014 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Levine principal investigator
Ontario Clinical Oncology Group, McMaster University
Raymond Reilly principal investigator
University of Toronto
Kathleen Pritchard principal investigator
Ontario Clinical Oncology Group (OCOG)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 111In-Pertuzumab + SPECT-CT in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 2 sites in Canada.
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 4 inclusion and 23 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: stopped early, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Accrual is very poor). Results are not available in the source record.
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?
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8. (time frame: 8 days). The study lists 2 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 NCT01805908, 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 6 Jun 2016.