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Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab

NCT02248571 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-11-13

No results posted yet for this study

Summary

This is a clinical trial with a crossover design to determine patients' preference for capecitabine in combination with bevacizumab or everolimus in combination with exemestane for advanced breast cancer patients and to evaluate, if any combination is associated with a better quality of life.

To identify patients' preference for either therapy in this trial, patients without disease progression or other reasons for early discontinuation will be asked for their treatment preference and their treatment satisfaction. To correlate patients' preference with other patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and throughout the study, using dedicated questionnaires.

With similarly active treatment options, it is of utmost importance to identify the treatment that has the least negative impact on the patients' quality of life.

Conditions

  • Breast Cancer Recurrent
  • HER2/Neu-negative Carcinoma of Breast
  • Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

DRUG

Bevacizumab

administered as combined therapy with Capecitabine

DRUG

Capecitabine

administered as combined therapy with Bevacizumab

DRUG

Everolimus

administered as combined therapy with Exemestane

DRUG

Exemestane

administered as combined therapy with Everolimus

OTHER

Patient questionaires

Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference

Sponsors & Collaborators

  • Arbeitsgemeinschaft fur Internistische Onkologie

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • Thomas Decker, MD · practice based oncology office Ravensburg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-08-31
Completion
2017-09-30

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 NCT02248571 on ClinicalTrials.gov