First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNathalie Levasseur
About this trial
The goal of this clinical trial is to learn if the drug Sacituzumab govitecan (SG) reduces disease progression when used as a first-line treatment in adults with advanced triple-negative breast cancer (TNBC) who have not received prior treatments in the advanced setting. It will also look at whether the effectiveness of the drug differs between TNBC adults with homologous recombination deficiency (HRD) subtypes and those with non-HRD subtypes. The main questions this study aims to answer are:
* Will patients with advanced TNBC who haven't received prior treatment in the advanced setting respond better (i.e., slowed disease progression) when given SG as a first-line treatment? * Does the overall response rate of SG differ between HRD vs non-HRD advanced TNBC patients without prior treatment in the advanced setting?
Participants will:
* Be given drug SG on days 1 and 8 of 21-day cycle(s) * Will continue (repeat) 21-day cycles until disease progression or voluntary withdrawal * Visit the clinic for treatments on days 1 and 8 * Have long-term follow-up every 12 weeks via phone or in-clinic
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent.
Age >18 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted according to local guidelines.
For participants of child-bearing potential (menstruation within <2 years): negative serum pregnancy test within 14-days prior to enrollment and must be willing to use Health Canada-approved effective contraception methods (e.g., hormonal contraceptives, intrauterine device or system, tubal ligation, or double barrier method) starting 1 week prior to study treatment, throughout the study, and for 6 months following the last dose of SG.
Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and/or radiotherapy), including those who are PDL1 negative (combined positive score [cps] <10), immuno-oncology therapy ineligible, or who had early-relapse after neoadjuvant therapy and not eligible for immuno-oncology in the first-line setting.
Disqualifiers
Are within 4 weeks of participating in any other type of medical research judged by the Investigator to not be scientifically or medically compatible with this study.
Tumour not accessible or not safe to perform biopsies.
Has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.
Has received prior antibody-drug conjugate containing a topoisomerase 1 inhibitor.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab Govitecan (SG)
DrugAdminister Sacituzumab Govitecan (SG) at 10 mg/kg as an intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. SG should not be administered as an IV push or bolus.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Sacituzumab GovitecanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR) of SG in advanced TNBC
To evaluate the overall response rate (ORR) of Sacituzumab govitecan (SG) in advanced triple-negative breast cancer (TNBC) patients without prior treatment in the advance setting, stratified by molecular subtypes using whole-genome and transcriptome analysis (WGTA).
Time frame
Up to an average of 6 months2
ORR of SG between HRD vs non-HRD in advanced TNBC
2\. To compare the ORR of SG between homologous recombination-deficient (HRD) vs non-HRD advanced TNBC patients without prior treatment in the advance setting, utilizing WGTA.
Time frame
Up to an average of 6 monthsSecondary outcomes
1
Evaluate clinical benefit rate (CBR) of SG in advanced TNBC
To evaluate the clinical benefit rate (CBR) of SG in advanced TNBC, stratified by molecular subtypes identified through WGTA.
Time frame
Up to an average of 6 months2
Assess progression-free survival (PFS) and overall-survival (OS) in advanced TNBC treated with SG
To assess progression-free survival (PFS) and overall survival (OS) in advanced TNBC patients receiving SG, stratified by molecular subtypes using WGTA.
Time frame
Up to an average of 12 months3
Number of advanced TNBC participants receiving SG in first-line setting with treatment-related adverse events as assessed by CTCAE v5.0
To assess the safety and toxicity profile in advanced TNBC participants receiving SG in the first-line setting per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for grade 2-4 toxicities.
Time frame
Up to an average of 3 months4
Changes in health-related quality of life when treated with SG
To assess changes in health-related quality of life using EORTC QLQ-CL30 version 3.0 questionnaire in advanced TNBC patients undergoing treatment with SG.
Time frame
At follow-up, within 30 days following the last dose of study drugSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nathalie Levasseur
Lead sponsor
British Columbia Cancer Agency
Sponsor institution
British Columbia Cancer Agency
Collaborator
Source ClinicalTrials.gov