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New treatment option for Breast Cancer
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?
Sacituzumab Govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
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
- Advanced hormone positive (HR+), HER2 negative breast cancer continues to pose a challenge when patients have progressed on CDK4/6 inhibitor and endocrine therapy leaving limited treatment options. Antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have changed practice due to significant improvement in progression free survival (PFS) and overall survival (OS) seen in this disease setting.
- 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
- Patients must meet all of the following to be eligible for participation in this study:
- 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.
You likely can't join if
- Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
- 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
See the full eligibility criteria
- Patients must meet all of the following to be eligible for participation in this study:
- 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. Patients with imaging confirmed inoperable locally...
- 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. Tumor lesions situated in a previously irradiated area are considered...
- ECOG PS 0-2
- Life expectancy ≥ 3 months
- Acceptable bone marrow and organ function defined by the following laboratory values:
- 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. (Controlled brain metastasis is defined as no longer symptomatic from brain metastasis or no longer...
- Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
- 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. grade 2...
- 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's taking place
- 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 - 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?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.