HER-2 Positive Breast Cancer Clinical Trial
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
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01305941 -
A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases
|
Phase 2 | |
Completed |
NCT01432223 -
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
|
Phase 2 | |
Completed |
NCT01433926 -
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years
|
N/A | |
Recruiting |
NCT05871918 -
A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer
|
Phase 3 | |
Terminated |
NCT02598310 -
Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02568839 -
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT02675231 -
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT02154529 -
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01565200 -
HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
|
Phase 2 | |
Completed |
NCT01340430 -
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02947685 -
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
|
Phase 3 | |
Completed |
NCT02066532 -
Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01583426 -
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
|
Phase 3 | |
Completed |
NCT01677455 -
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT01361945 -
AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02326974 -
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
|
Phase 2 | |
Terminated |
NCT02131506 -
A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
|
Phase 1 | |
Completed |
NCT00788931 -
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
|
Phase 1 | |
Completed |
NCT02488564 -
A Study of Liposomal Doxorubicin + Docetaxel + Trastuzumab + Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer
|
Phase 2 | |
Completed |
NCT02492711 -
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
|
Phase 3 |