HER-2 Positive Breast CancerPETRANCT04644406
PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
An observational study of HER-2 Positive Breast Cancer, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER-2 Positive Breast Cancer
- What is being tested?
- Efficacy of the Pertuzumab-Trastuzumab combination
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- Dec 2020to Jun 2023
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns adults with non-operable, locally advanced or metastatic HER-2 positive breast cancer, treated by chemotherapy in combination with any trastuzumab biosimilar and pertuzumab
Who may be able to join
- Histologically confirmed Patients ≥ 18 years-old with non-operable, locally advanced, or metastatic HER-2 positive breast cancer Docetaxel, Paclitaxel or Vinorelbine-based chemotherapy administred in combination with any trastuzumab biosimilar and with pertuzumab for the first-line treatment of the non-operable, locally advanced or metastatic HER-2 positive breast cancer.
- WHO Performance status 0-2 Measurable or non-measurable (but radiologically evaluable) disease as per modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- Adequate cardia function at baseline defined by a left ventricular ejection fraction of 50% or more within 2 months before treatment start
- Adequate baseline organ function, evidenced by the following laboratory results within 2 months before treatment start:
- Hemoglobin ≥ 9 g/dL Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 × ULN in patients with documented Gilbert's Syndrome.
- Glomerular Filtration Rate (GFR) ≥ 30 ml/min according to MDRD formula or CKD-EPI formula or Cockcroft and Gault formula SGOT (AST), SGPT (ALT) and alkaline phosphatase ≤ 5 × ULN Patient's consent to data collection
Who cannot join
- Prior exposure to trastuzumab in the metastatic setting, patients may have received adjuvant or neoadjuvant trastuzumab and/or pertuzumab with an interval of at least 12 months between completion of the adjuvant or neoadjuvant anti-HER2 therapy and the diagnosis of metastatic breast cancer.
- History of allergic reactions attributed to compounds of chemical or biological composition similar to trastuzumab, pertuzumab, or to chemotherapy components Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND
Clermont-Ferrand
Hôpital Privé Drome Ardèche
Guilherand-Granges
CHU Limoges
Limoges
Hospices Civils de LYon
Lyon
Hôpital Tenon, AP-HP
Paris
CHU Poitiers
Poitiers
About this study
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials.
Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.
Read more
A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.
PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.
- Conditions
- HER-2 Positive Breast Cancer
- Being tested
- Efficacy of the Pertuzumab-Trastuzumab combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of the Pertuzumab-Trastuzumab combinationOther
The efficacy of the pertuzumab in combination with one of the biosimilars of Trastuzumab will be estimated by measuring the PFS at 6 months after the beginning of the treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS-R
The primary end-point is the 6 months PFS-R. It will be defined as the proportion of included patients who achieve complete response (CR), partial response (PR) or stable disease (SD) at 6 months after the beginning of the treatment.
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644406
- Sponsor's protocol ID
- 69HCL19_0593
- Acronym
- PETRA
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04644406
- Acronym / sponsor ID
- PETRA / 69HCL19_0593
- Conditions
- HER-2 Positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Nov 2020 (actual)
- 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.
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials.
Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.
A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.
PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns adults with non-operable, locally advanced or metastatic HER-2 positive breast cancer, treated by chemotherapy in combination with any trastuzumab biosimilar and pertuzumab
Key inclusion criteria (6 listed)
- Histologically confirmed Patients ≥ 18 years-old with non-operable, locally advanced, or metastatic HER-2 positive breast cancer Docetaxel, Paclitaxel or Vinorelbine-based chemotherapy administred in combination with any trastuzumab biosimilar and with pertuzumab for the first-line treatment of the non-operable, locally advanced or metastatic HER-2 positive breast cancer.
- WHO Performance status 0-2 Measurable or non-measurable (but radiologically evaluable) disease as per modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- Adequate cardia function at baseline defined by a left ventricular ejection fraction of 50% or more within 2 months before treatment start
- Adequate baseline organ function, evidenced by the following laboratory results within 2 months before treatment start:
- Hemoglobin ≥ 9 g/dL Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 × ULN in patients with documented Gilbert's Syndrome.
Key exclusion criteria (2 listed)
- Prior exposure to trastuzumab in the metastatic setting, patients may have received adjuvant or neoadjuvant trastuzumab and/or pertuzumab with an interval of at least 12 months between completion of the adjuvant or neoadjuvant anti-HER2 therapy and the diagnosis of metastatic breast cancer.
- History of allergic reactions attributed to compounds of chemical or biological composition similar to trastuzumab, pertuzumab, or to chemotherapy components Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes
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 |
|---|---|---|
| Efficacy of the Pertuzumab-Trastuzumab combinationThe efficacy of the pertuzumab in combination with one of the biosimilars of Trastuzumab will be estimated by measuring the PFS at 6 months after the beginning of the treatment. | Other | – |
Primary outcome
PFS-R
Time frame: 6 months after inclusion
The primary end-point is the 6 months PFS-R. It will be defined as the proportion of included patients who achieve complete response (CR), partial response (PR) or stable disease (SD) at 6 months after the beginning of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER-2 Positive Breast Cancer, run by Hospices Civils de Lyon at 6 sites in France.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelie COMTE, MD (+33 (0)4 78 86 43 18, aurelie.comte@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS-R (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.