NCT03749850|UnknownPhase 1DMCFDA Drug
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer
i-GO
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
12
1 country
1
Study Start
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In this phase I feasibility study, the investigators evaluate the combination of lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local hyperthermia and cyclophosphamide (C), for the local treatment of the primary breast tumour in patients with metastatic breast cancer. When heated to 40-43 degrees Celsius (ºC), LTLD releases a very high concentration of doxorubicin locally within seconds. Hyperthermia of the primary tumour will be induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) on a dedicated Sonalleve MR-HIFU breast system. The investigators hypothesize that by substituting doxorubicin (A) in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia, optimal local tumour control can be achieved without compromising systemic toxicity or efficacy. This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2018
Actual (reported)November 21, 2018
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of adverse events assessed by CTCAE v 5.0
Safety and tolerability of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
Incidence of dose limiting toxicities
Safety and tolerability of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
Incidence of necessity for dose adjustments, delay or early cessation
Safety and tolerability of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
LTLD in combination with MR-HIFU induced hyperthermia and cyclophosphamide Single arm study
Patients will receive up to six cycles at three-weeks intervals of: * Intravenous LTLD dosed at 50mg/m2 administered during the MR-HIFU treatment * 60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour * Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment In case of toxicity, LTLD, cyclophosphamide and/or hyperthermia dosages will be adjusted as specified in the study protocol.
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
de Maar JS, Suelmann BBM, Braat MNGJA, van Diest PJ, Vaessen HHB, Witkamp AJ, Linn SC, Moonen CTW, van der Wall E, Deckers R. Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study. BMJ Open. 2020 Nov 26;10(11):e040162. doi: 10.1136/bmjopen-2020-040162.
Britt BM Suelmann, MD
UMC Utrecht
First Submitted
November 9, 2018
First Posted
November 21, 2018
Study Start
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2022
Incidence and severity of post-procedural pain
Safety and tolerability of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
Patient reported tolerability via an adapted version of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Tolerability of the study treatment. Scores will be described.
Baseline, day 49 and day 112
Patient reported tolerability via the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Tolerability of the study treatment. Scores will be described.
Baseline, and on day 14 of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Incidence of cardiotoxity
Safety and tolerability of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
Description of MR thermometry data (describing the temperatures achieved)
Feasibility of the study treatment
On day 1 (study treatment day) of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Duration of procedures on a treatment day
Feasibility of the study treatment
On day 1 (study treatment day) of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Number of completed cycles with MR-HIFU induced hyperthermia, ThermoDox and cyclophosphamide
Feasibility of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
The number of cycles in which hyperthermia was sufficient: at least 30 minutes at the target temperature of 40-42°C
Feasibility of the study treatment
From first study treatment (day 1) until the end of study visit between day 161 and 175
Radiological objective response locally on breast Magnetic Resonance Imaging, assessed by RECIST 1.1.
Assessed after 2 cycles and after 6 cycles of the study treatment. Each cycle is 21 days.
Radiological objective response systemically on Computed Tomography, assessed by RECIST 1.1 or (for patients without RECIST-measurable disease) Positron Emission Tomography Computed Tomography, assessed by PERCIST 1.0
Assessed after 2 cycles and after 6 cycles of the study treatment. Each cycle is 21 days.
Patients will receive up to six cycles at three-weeks intervals of: \- 60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour. In case of toxicity, hyperthermia dosages will be adjusted as specified in the study protocol.
Patients will receive up to six cycles at three-weeks intervals of: \- Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment In case of toxicity, cyclophosphamide dosages will be adjusted as specified in the study protocol.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 17, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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