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Dose EScalation Induction of EvERolimus

NCT02387099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-02-23

No results posted yet for this study

Summary

The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor;

Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis especially during the first 12 weeks of treatment leading cause for treatment discontinuation not related to tumor progression;

GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in combination with paclitaxel for patients without response to 4 cycles epirubicin/cyclophosphamide with/without bevacizumab.

A dose-escalation schema was successfully used to improve tolerability of everolimus together with the cytotoxic Agent.

Everolimus plus exemestane has improved the prognosis of metastatic breast cancer significantly. Desiree-study aims to improve the tolerability, which is necessary in order to achieve an adequate dose intensity for the patients in Routine care.

Conditions

Interventions

DRUG

3 weeks Dose Induction of Everolimus

Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer. All patients will be treated within the approved indication of everolimus in combination with exemestane. Patients will be randomized in a 1:1 ratio

DRUG

3 weeks Conventional Everolimus Dosing

Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer. All patients will be treated within the approved indication of everolimus in combination with exemestane. Patients will be randomized in a 1:1 ratio

DRUG

Open Label Phase with conventional 10mg Everolimus Dosing week 4-24

All patients will receive open label Everolimus with Exemestane for 21 weeks according to label

DRUG

Standard Care after 24 weeks

It is up to the discretion of the investigator to continue with Everolimus+Exemestane beyond 24 weeks

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Sibylle Loibl, Prof., MD · ASCO, ESGO, ESMO, DKG, DGGG, AGO, DGS, BIG, BCIRG, St. Gallen Faculty Member, SABCS Faculty member

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2021-05-31
Completion
2021-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
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 NCT02387099 on ClinicalTrials.gov