First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Sacituzumab Govitecan (SG)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Nathalie Levasseur
Lead sponsor
British Columbia Cancer Agency
Sponsor institution
British Columbia Cancer Agency
Collaborator
Source ClinicalTrials.gov