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Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases
Sponsor: Thomas Hatschek
Summary
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.
Official title: PREDIX Luminal B - Neoadjuvant Response-guided Treatment of ER Positive Tumors With High Proliferation or Low Proliferation With Metastatic Nodes. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
181
Start Date
2015-02
Completion Date
2031-12-31
Last Updated
2021-08-03
Healthy Volunteers
No
Interventions
Paclitaxel
Any brand of paclitaxel may be used, excluding nab-paclitaxel
Tamoxifen + Palbociclib
Any brand of tamoxifen may be used
Aromatase Inhibitor + Palbociclib
Any brand of letrozole, anastrozole or exemestane may be used
Goserelin + Aromatase Inhibitor + Palbociclib
Any brand of letrozole, anastrozole or exemestane may be used
Locations (3)
Södersjukhuset
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Capio S:t Göran Hospital
Stockholm, Sweden