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Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

NCT02592083 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-07

No results posted yet for this study

Summary

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-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.

Conditions

  • Early-Stage Breast Carcinoma
  • Hormone Receptor Positive Tumor

Interventions

DRUG

Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin

DRUG

Palbociclib

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
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-02-28
Completion
2029-02-28

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 NCT02592083 on ClinicalTrials.gov