HER-2 Positive Breast Cancer Clinical Trial
Official title:
PREDIX HER2 - Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
The purpose of this trial is to evaluate efficacy and toxicity of either the combination of
docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of
therapy to the opposite treatment alternative is applicable in case of lack of response after
two courses of treatment, or for medical reasons under exceptional circumstances (drug
reaction, other medical conditions) at any point. After termination of the primary treatment
follow-up for five years.
A translational subprotocol is a mandatory part of the study protocol, with exception for the
use of PET-CT evaluations.
Patients with HER2-positive tumors >20 mm or verfied regional lymph node metastases are
randomized to either arm A, the combination of docetaxel, trastuzumab sc (Herceptin SC®) and
pertuzumab (Perjeta®) or arm B, trastuzumab emtansin (Kadcyla®). Switch to the opposite
treatment is performed in case of lack of response after evaluations with mammography and
ultrasound, alternatively MRI breast after the 2nd, 4th and 6th course of treatment.
Postoperative treatment, trastuzumab, radiotherapy, eventual endocrine treatment) according
to standard guidelines. Structured follow-up visits yearly for five years, including
reporting of persistent treatment-related toxicity, HRQoL, recurrence and death.
The trial contains also a translational subprotocol:
1. PET-CT using FDG, confined to the chest, is performed before start, and after the 2nd
and 6th course (functional imaging, optional).
2. Core biopsies from the tumor are collected before start and after the 2nd course of
treatment. If residual tissue is available, samples are collected from the surgical
sample
3. Blood samples are collected repeatedly during the ongoing treatment and yearly follow-up
4. FNAs from metastases in case of recurrence during follow-up
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01432223 -
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
|
Phase 2 | |
| Completed |
NCT01305941 -
A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases
|
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 | |
| 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 |
NCT01677455 -
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
|
Phase 2 | |
| Completed |
NCT01583426 -
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
|
Phase 3 | |
| 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 | |
| Not yet recruiting |
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
|
||
| 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 |