Clinical trial NCT04644406: PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER-2 Positive Breast Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PFS-R
timeFrame: 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND
city: Guilherand-Granges
country: France
facility: Hôpital Privé Drome Ardèche
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hospices Civils de LYon
city: Paris
country: France
facility: Hôpital Tenon, AP-HP
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References: