Advanced Triple Negative Breast Cancer study: Sacituzumab Govitecan
Official title First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
ClinicalTrials.gov ID: NCT07299409
What this study is testing
What is Sacituzumab Govitecan (SG)?
Sacituzumab Govitecan (SG) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for advanced triple negative breast cancer.
Also referred to as Trodelvy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For participants of child-bearing potential (menstruation within \<2 years): negative serum pregnancy test within 14-days prior to enrollment and...
- For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry: i.
- Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery...
You likely can't join if
- Are within 4 weeks of participating in any other type of medical research judged by the Investigator to not be scientifically or medically compatible...
- 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.
- Has a history of significant cardiovascular diseases, such as congestive heart failure greater than New York Heart Association (NYHA) Class II...
- Has a history or evidence of any condition or laboratory abnormality that would place the participant at undue risk, as determined by the...
See the full eligibility criteria
Who can join
- 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...
- For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry: i. Prior bilateral oophorectomy ii. Age \> 60 iii.
- 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...
- Histologically and/or cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
- HER2-negative breast cancer (based on most recently analyzed biopsy) defined as negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+.
- Not previously received systemic therapy in the advanced setting.
- Participants can have measurable or non-measurable disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy \> 3 months.
- Acceptable bone marrow and organ function defined by the following laboratory values without transfusion or growth factor support within 2 weeks of treatment initiation: a. Absolute neutrophil count \> 1.0 x 109/L i.
- Consents to allow access and provision of pre- and post-treatment biopsy specimens for study purposes.
- Able to communicate with the Investigator and comply with the requirements of the study procedures.
- Controlled brain metastasis (as per clinical determination) is allowed in the study at least 4 weeks before treatment.
What rules you out
- 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.
- Has a history of significant cardiovascular diseases, such as congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, serious cardiac arrhythmia...
- Has a history or evidence of any condition or laboratory abnormality that would place the participant at undue risk, as determined by the Investigator.
- Currently active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).
- For participants with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening.
- Those who are HCV antibody positive with undetectable HCV viral load may be eligible.
- Has an active human immunodeficiency virus (HIV) infection (e.g., with detectable viral load). a. Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE version 5.0 grade \<1 (except toxicities not considered a safety risk for the participant at Investigator's discretion, e.g.
- Have an active second malignancy. Participants with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured...
- Have known, untreated, active central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they have stable CNS disease, defined as no longer symptomatic from...
- Pregnancy or breast feeding.
- Has inadequate hematologic, renal and hepatic function as outlined above in inclusion criteria.
- Has a pre-existing condition with uncontrolled diarrhea, chronic inflammatory bowel disease (Ulcerative colitis, Crohn's Disease), or gastrointestinal perforation within 6-months prior to enrollment.
- Has active serious infection requiring antibiotics.
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Received a live vaccine within 30 days prior to enrollment.
- Current and/or prior use of systemic anticancer therapies, aside from the study drug. High-dose systemic corticosteroids (\>20mg of prednisone or its equivalent) is not allowed within 2 weeks of Cycle 1 Day 1.
- Persons of child-bearing potential (i.e., menstruation within \< 2 years) who are unable or unwilling to use Health Canada approved highly effective methods of contraception (hormonal contraceptives, intrauterine device...
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.