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ACTIVE NOT RECRUITING
NCT02603679
PHASE2

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

Sponsor: Thomas Hatschek

View on ClinicalTrials.gov

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

DRUG

Paclitaxel

Any brand of paclitaxel may be used, excluding nab-paclitaxel

DRUG

Tamoxifen + Palbociclib

Any brand of tamoxifen may be used

DRUG

Aromatase Inhibitor + Palbociclib

Any brand of letrozole, anastrozole or exemestane may be used

DRUG

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