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Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients

NCT02850419 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-04-07

No results posted yet for this study

Summary

The 105-15-201 study is designed to assess the effectiveness and tolerability of the combination of heat-activated target therapy (radiotherapy + hyperthermia + lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer patients.

Conditions

Interventions

DRUG

ThermoDox (Thermally Sensitive Liposomal Doxorubicin)

A dose of 40 mg/m2 will be administered at each cycle for a total of 6 cycles. ThermoDox will be administered in conjunction with hyperthermia.

RADIATION

Radiation Therapy

A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.

DEVICE

Superficial Hyperthermia

Thermal dose is an one-hour treatment at a temperature between 40 and 43 degrees Celsius at the target site.

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Pietro Gabriele, M.D. · FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA - IRCCS CANDIOLO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2019-12-31
Completion
2020-02-29
FDA Drug
Yes

Countries

  • Czechia
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT02850419 on ClinicalTrials.gov