MedTrace Logo

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

NCT02603679 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2021-08-03

No results posted yet for this study

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.

Conditions

  • Early-Stage Breast Carcinoma
  • Estrogen Receptor Positive Tumor

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

Sponsors & Collaborators

  • Thomas Hatschek

    lead OTHER

Principal Investigators

  • Thomas Hatschek, Assoc Prof · Breast-Sarcoma Unit, Dept. of Oncology, Karolinska University Hospital

  • Jonas Bergh, Professor · Dept. of Oncology-Pathology, Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2021-07-30
Completion
2031-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603679 on ClinicalTrials.gov