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Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

NCT03220178 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2022-01-06

No results posted yet for this study

Summary

In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.

Conditions

  • Breast Neoplasm

Interventions

DRUG

Palbociclib

Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle

DRUG

Fulvestrant

500mg per use-after first application, again at wk2, then once per month

DRUG

Anastrozole

1mg per day

DRUG

Letrozole

2,5mg/day

DRUG

Exemestane

25mg/day

Sponsors & Collaborators

  • WSG WOMEN´S HEALTHCARE STUDY GROUP

    collaborator UNKNOWN

  • Cankado GmbH

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • AGO-TraFo

    collaborator UNKNOWN

  • AGO-B

    collaborator UNKNOWN

  • Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.

    collaborator UNKNOWN

  • Palleos Healthcare GmbH

    lead INDUSTRY

Principal Investigators

  • Iris Reiser, PhD · Palleos Healthcare GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2021-12-07
Completion
2021-12-07

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

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 NCT03220178 on ClinicalTrials.gov