The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To select in the first part the SAR566658 dose based on Objective Response Rate
(ORR) and
safety of 2 dose levels and to demonstrate in the second part the efficacy of
the selected dose
based on ORR.
Secondary outcome
-To assess:
-Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free
Survival (PFS),
and Time To Progression (TTP);
-The impact of ocular primary prophylaxis on the incidence of keratopathies
Background summary
At the moment limited treatment options are available for triple negative
metastatic breast cancer (TBN) patients. No targeted therapy is available.
About 20% of all breast cancers is TBN, and the majority of these patients will
receive this diagnoses before they reach the age of 40. 80% of these patients
are diagnosed with an aggressive form.
SAR566658 could offer a targeted therapy for a part of these patients, in which
previous treatments were not successful.
Study objective
The goal of the trial is to investigate the safety and efficacy of SAR566658,
if it is provided to CA6 protein positive metastaticTBN breastcancer patients.
Study design
Open label randomized trial.
Intervention
Patients receive 90 mg/m2 SAR566658 or 120 mg/m2 SAR566658 on day 1 and 8 of
each cycle.
Study burden and risks
The risks are related to the blood draws and the possible side effects of the
study drug. The burden for the patient will be the frequency of the visits to
the hospital.
Kampenringweg 45E
Gouda 2803PE
NL
Kampenringweg 45E
Gouda 2803PE
NL
Listed location countries
Age
Inclusion criteria
-Measurable Metastatic triple negative breast cancer (TNBC).
-Patients with CA6-positive disease.
-Patients received at least 1 prior chemotherapy regimen but no more than 3 for advanced/metastatic disease.;-Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant or metastatic setting.
Exclusion criteria
-Eastern Cooperative Oncology Group (ECOG) performance status *2.
-Patient less than 18 years old.
-Pregnant or breast-feeding women.
-Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of study drug.
-Wash out period of less than 3 weeks or 5 half-lives from previous antitumor chemotherapy, immunotherapy, or any investigational treatment.
-History of brain metastasis, spinal cord compression or carcinomatous meningitis, or new evidence of brain leptomeningeal disease.
-Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments.
-Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
-Poor bone marrow reserve and/or poor organ function.
-Symptomatic peripheral neuropathy Grade *2.
-Previous history of chronic corneal diseases or unresolved acute nonrecurrent corneal conditions.
-Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
-Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors, unless it can be discontinued at least 2 weeks before 1st administration of SAR566658.
-Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001962-27-NL |
| CCMO | NL58637.068.16 |
| Other | U1111-1182-7044 |