OncRef

Clinical Trial: NCT02603679

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Thomas Hatschek
Information Provided By:Karolinska University Hospital
Last Update Posted:2021-08-03

Study Overview

Brief 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

Conditions

Early-Stage Breast Carcinoma, Estrogen Receptor Positive Tumor

Intervention / Treatment

  • Drug: Paclitaxel
  • Drug: Tamoxifen + Palbociclib
  • Drug: Aromatase Inhibitor + Palbociclib
  • Drug: Goserelin + Aromatase Inhibitor + Palbociclib

Other Study ID Numbers

  • PREDIX LumB

Start Date (Actual)

2015-02

Primary Completion Date (Actual)

2021-07-30

Study Completion Date (Estimated)

2031-12-31

Enrollment (Actual)

181

Study Type

Interventional

Phase

Phase 2