Advanced (locally advanced inoperable or metastatic) triple negative breast cancer progressing after first-line therapy
Conditions
Interventions
Product Name: ixazomib
Product Code: MLN9708
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ixazomib
CAS Number: 1072833-77-2
Current Sponsor code: MLN9708
Concentration unit: mg milligram(s)
Sponsors
AGMT gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Metastatic or locally advanced (without curative loco-regional treatment options with curative intention) adenocarcinoma of the breast, histologically confirmed • Triple-negative subtype defined as the absence or very weak staining for estrogen receptor (IHC =65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women • Serious medical or psychiatric disorders that would interfere with the patient’s safety or informed consent • Clinically significant cardiovascular disease, requiring medication during the study and which might interfere with regularity of the study treatment, or not controlled by medication. • Radiation of the target lesion within the last 4 weeks prior to randomization • Prior radiation to = 30% of bone marrow • Active bacterial, viral or fungal infection • Known HIV infection • Patients with clinically apparent brain metastases or evidence of a spinal cord compression • Major surgery within 14 days before enrollment • Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort. • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial • Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not • History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible • Prior treatment with a platinum derivative (except in (neo-)adjuvant setting if breast cancer recurrence did not occur within 12 months after (neo-)adjuvant chemotherapy completion) and/or with a proteasome inhibitor • Known hypersensitivity to the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Phase I: Determination of maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) • Phase II: Overall response rate (ORR);Secondary Objective: • Safety profile • Overall response rate • Clinical benefit rate • Progression-free survival (PFS) • Quality of Life (EORTC QLQ-C30 and EORTC QLQ-BR23);Primary end point(s): Phase I: Determination of maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) Phase II: Overall response rate (ORR) ;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when applicable data for all patients are available | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I • Safety profile • Overall response rate • Clinical benefit rate (CR, PR or stable disease for at least 24 weeks) • Progression-free survival (PFS) • Quality of Life (EORTC QLQ-C30 and EORTC QLQ-BR23) Phase II • Clinical benefit rate (CR, PR or stable disease for at least 24 weeks) • Progression-free survival (PFS) • Safety profile • Quality of Life (EORTC QLQ-C30 and EORTC QLQ-BR23) ;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when applicable data for all patients are available | — |
Countries
Austria
Contacts
Public ContactClinical Trials Lead Manager
AGMT gGmbH
Outcome results
None listed