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New treatment option for Triple Negative Breast Neoplasms
Official title A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
ClinicalTrials.gov ID: NCT06841354
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast neoplasms.
Also referred to as Sac-TMT, MK-2870.
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
- Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
- Phase 3: a large, late-stage study
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
- The main include but are not limited to the following:
- Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
- Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
- Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative...
- Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has breast cancer amenable to treatment with curative intent
- Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
- Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays...
See the full eligibility criteria
- The main include but are not limited to the following:
- Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
- Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
- Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
- Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated...
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- The main exclusion criteria include but are not limited to the following:
- Has breast cancer amenable to treatment with curative intent
- Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
- Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has skin only metastatic disease
- Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic...
- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid...
- History of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Athens, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Clinton, Maryland, United States
- Olney, Maryland, United States
- Silver Spring, Maryland, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
+ 209 more site(s).
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 Mobile, Alabama, United States; Chandler, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 223 more location(s). 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.