Breast Cancer study: Sacituzumab Govitecan
Official title Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06665178
What this study is testing
What is Sacituzumab Govitecan?
This is an investigational medicine being studied as a potential treatment for advanced breast cancer. It is designed to attach to specific cells and deliver a chemotherapy drug directly to them.
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
- This study aims to find out if a specific cancer drug works after another one stops working. It also looks for genetic markers that predict which patients will respond to this treatment sequence.
- Who it's for
- People with advanced breast cancer that is hormone-receptor positive and HER2-low, who have already tried other standard treatments.
- What's involved
- Participants will receive a specific cancer drug called sacituzumab govitecan. Doctors will also take a small tissue sample from the tumor to test its genes.
- Time commitment
- The study involves regular visits for treatment and blood tests, with the duration depending on how long the treatment continues.
- Phase 2: a mid-size study of how well it works
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 signed informed consent approved by UBC/BC Cancer REB
- Female or male patients, regardless of race and ethnic group, who are ≥18 years old at the time of informed consent
- Patients with locally advanced or metastatic ER+/HER2 low (defined as IHC 1+ or 2+ but FISH or CISH negative by ratio as per ASCO/CAP guidelines)...
- Prior treatment must have included prior endocrine based treatment in the metastatic setting in conjunction with a CDK4/6 inhibitor.
- Prior treatment must include at least 1 line of chemotherapy which must include trastuzumab deruxtecan (T-DXd) as the immediate prior line of therapy...
You likely can't join if
- Patient is currently participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Patient has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.
- Patients not available for follow up
- Patients who are not willing to consider systemic treatment options
- Tumor not accessible or not safe to perform biopsies
- Patient has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE v.
See the full eligibility criteria
- Willing and able to provide signed informed consent approved by UBC/BC Cancer REB
- Female or male patients, regardless of race and ethnic group, who are ≥18 years old at the time of informed consent
- Patients with locally advanced or metastatic ER+/HER2 low (defined as IHC 1+ or 2+ but FISH or CISH negative by ratio as per ASCO/CAP guidelines) breast cancer.
- Prior treatment must have included prior endocrine based treatment in the metastatic setting in conjunction with a CDK4/6 inhibitor.
- Prior treatment must include at least 1 line of chemotherapy which must include trastuzumab deruxtecan (T-DXd) as the immediate prior line of therapy prior to study enrollment
- The tumour must be accessible to be able to safely perform image guided biopsies for WGS and WTS.
- Negative serum pregnancy test at baseline for pre-menopausal patients (within 14 days prior to randomization) and agreement to use medically approved precautions to prevent pregnancy during the study and for 12 weeks...
- Patients can have measurable or non measurable (but assessable) disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally.
- ECOG PS 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥1.0 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥9.0 g/dL
- INR ≤1.5
- Serum creatinine clearance \>50 mL/min
- In absence of liver metastases, direct bilirubin ≤1.5 x ULN, ALT and AST should be below ≤2.5 x ULN. If the patient has liver metastases, ALT and AST should be \< 5.0 x ULN.
- Controlled brain metastasis (as per clinical determination) is allowed in the study at least 4 weeks before treatment.
- Patient is currently participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Patient has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.
- Patients not available for follow up
- Patients who are not willing to consider systemic treatment options
- Tumor not accessible or not safe to perform biopsies
- Patient has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE v. 5.0 grade ≤1 (except toxicities not considered a safety risk for the patient at investigators discretion: e.g.
- Have an active second malignancy. Patients with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with...
- Have known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they have stable CNS disease (defined as no longer symptomatic from brain metastasis...
- Pregnancy and breast feeding
- Patient without an adequate hematologic, renal and hepatic function as per above inclusion criteria
- Patient has a pre-existing condition with uncontrolled diarrhea, chronic inflammatory bowel disease or GI perforation within 6 months prior to enrollment.
- Have active serious infection requiring antibiotics.
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.