Locally Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
phase I, safety
Brief summary
The purpose of this study is to evaluation the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced breast cancer.
Detailed description
Additional objectives are: * parallel sampling of blood and saliva for the determination of drug concentrations and pharmacokinetic parameters in a substudy on the day of first application and during steady state * attempt to establish a therapeutical drug monitoring * collection of further safety data during prolonged add-on treatments (compassionate use)
Interventions
DRUGartesunate
add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
Sponsors
Hector-Stiftung
Dafra Pharma
Monika-Kutzner Stiftung, Berlin, Germany
HEIFAN-Heidelberger Förderverein d. Ambulanz f. Naturheilkunde eV, Heidelberg, Germany
Heidelberg University
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
dose escalation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically confirmed breast cancer * Distant metastases or locally advanced breast cancer * Age ≥ 18 years * ECOG performance ≤ 2 * Life expectancy of at least 6 months * Written informed consent * individual standard therapy according to guidelines * Oral intake of trial medication possible * Compliance with study procedures * Women of childbearing potential: negative pregnancy test before start of medication * Use of a highly effective method of birth control during intake of add-on therapy for women of childbearing potential being sexually active Inclusion Criteria for Extended Treatment Phase: * Participant of the phase I study ARTIC M33/2 who had tolerated the study medication for 4±1 weeks without clinically relvant adverse events or after improvement to ≤ grade 2 * Participant of the phase I study ARTIC M33/2 with possible benefit by continuation or restart of the add-on therapy after a next progression according to current scientific knowledge * Written informed consent for extended treatment phase * Consent of the responsible oncologist * Compliance for further intake and follow-up expected Inclusion Criteria for Individual Compassionate Use: * Participant of the phase I study ARTIC M33/2 * Available standard therapies have minimal or only short activity or intolerable side effects * Written informed consent for compassionate use * Consent of the responsible oncologist
Exclusion criteria
* Allergy to artesunate or to other artemisinin derivatives * Concurrent conditions interfering with patient safety * Communication problems * Concurrent participation in another clinical trial or 4 weeks prior to recruitment * Participation in a clinical trial with an unapproved drug 6 months prior to recruitment * Sinus bradycardia, bradyarrhythmia * AV-Block II° and III° * QTc \> 500 msec * Previously known long QT-syndrome * Concurrent intake of a medication with clinically relevant neurotoxicity or during 30 days prior to recruitment * Relevant neurological symptoms which might complicate the evaluation of the compatibility of the IMPD (f. e. cerebral metastases) or might be subject to worsening during intake of the IMPD * Radiotherapy 2 weeks prior of the intake of the IMPD * Concurrent intake of supplements or any other medication with unapproved efficacy f.e. vitamins, minerals or others (OTC) * Pregnancy and lactation * Ineffective mode of contraception in women of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting adverse events with possible, probable or definite relation with the respective dose level of the add-on therapy | 8-12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events relation between adverse events and add-on therapy, cortisol profile in saliva, overall response rate, clinical benefit, assessment of patients expectations | 8-12 weeks |
Other
| Measure | Time frame |
|---|---|
| Further safety data (adverse events) during prolonged treatments latest till the second progression during the add-on therapy with the study medication (compassionate use) | add-on treatments > 4+/- 1 weeks |
| Collection of further safety data during later individual compassionate use with monitoring if approbriate for the patients' health status | Depending on patients' preference and health status |
Countries
Germany
Outcome results
None listed