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New treatment option for Invasive Breast Cancer
Official title Sacituzumab Govitecan In TNBC
ClinicalTrials.gov ID: NCT04230109
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 invasive breast cancer.
Also referred to as IMMU-132.
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 research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: Sacituzumab govitecan (SG) Pembrolizumab (combination therapy with SG)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
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
- Female or male patients ≥ 18 years of age.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated.
- Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through...
You likely can't join if
- Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years...
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
- History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study...
- History of cardiac failure, known cardiomyopathy (LVEF \ 160 mmHg or \ 470 screening ECG
- Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.
See the full eligibility criteria
- Female or male patients ≥ 18 years of age.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated.
- Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP...
- Complete abstinence from intercourse of reproductive potential, or
- Consistent and correct use of 1 of the following methods of birth control:
- Nonhormonal intrauterine device (IUD); Hormonal IUD in conjunction with a barrier method; Female sterilization (have had surgical bilateral oophorectomy with or; without hysterectomy), total hysterectomy, or tubal...
- Male patients with female partners of childbearing potential must practice
- Complete abstinence from intercourse of reproductive potential
- Have a surgically successful vasectomy upon medical assessment, or
- Use condoms plus partner use of a contraceptive method with a failure rate of \<1% per year during treatment and until 3 months after last dose of study drug.
- ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements...
- Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
- Absolute neutrophil count (ANC) ≥ 1,500 per mm3
- Platelets ≥ 100,000 per mm3
- Hemoglobin ≥9.0 g/dL
- PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only).
- Serum creatinine \<1.5 mg/dL or creatinine clearance ≥50 mL/min (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)
- Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin \> 3 g/dL).
- Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting...
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
- History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.
- History of cardiac failure, known cardiomyopathy (LVEF \ 160 mmHg or \ 470 screening ECG
- Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to enrollment are eligible for this trial. Participants who are HBsAg positive are eligible if they have...
- Participants who are not good candidates for the study (as per investigator judgement)
- History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Danvers, Massachusetts, United States
- Newton, Massachusetts, United States
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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Boston, Massachusetts, United States; Danvers, Massachusetts, United States; Newton, Massachusetts, United States. 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.