BridgeMD
A clinical study of sac-TMT in people with breast cancer (MK-2870-032)
EU CTIS ID: 2024-520190-12-00
What this study is testing
1. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0) at the time of surgery, as assessed by local pathologist in all participants. 2. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to EFS as assessed by investigator in all participants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
- Has centrally confirmed diagnosis of BC that is triple-negative or hormone receptor (HR)-low positive/ human epidermal growth factor receptor-2 (HER2) negative, based on the American Society of Clinical Oncology/College of American Pathologists guidelines
- Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
- Has left ventricle ejection fraction of ≥50% or ≥ institution lower limit of normal as assessed by echocardiogram or multigated acquisition scan performed at screening
- Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin.
You likely can't join if
- Has Grade ≥2 peripheral neuropathy
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 5 years
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Concurrent active Hepatitis B or Hepatitis C virus infection
See the full eligibility criteria
- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
- Has centrally confirmed diagnosis of BC that is triple-negative or hormone receptor (HR)-low positive/ human epidermal growth factor receptor-2 (HER2) negative, based on the American Society of Clinical Oncology/College of American Pathologists guidelines
- Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
- Has left ventricle ejection fraction of ≥50% or ≥ institution lower limit of normal as assessed by echocardiogram or multigated acquisition scan performed at screening
- Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin.
- Has Grade ≥2 peripheral neuropathy
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 5 years
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Concurrent active Hepatitis B or Hepatitis C virus infection
- History of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has uncontrolled systemic disease (eg, uncontrolled hypertension or diabetes, or clinically symptomatic pleural effusion, pericardial effusion, or ascites)
- Has human immunodeficiency virus and a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed BC
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Japan
- Ukraine
- Philippines
- United States
- Korea, Democratic People's Republic of
- Saudi Arabia
- New Zealand
- Hong Kong
- Colombia
- Malaysia
- Turkey
- South Africa
- Canada
- Argentina
- Israel
- India
- Peru
- Taiwan
- Guatemala
+ 7 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Japan; Ukraine; Philippines; United States; Korea, Democratic People's Republic of and 21 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 EU CTIS; the study team decides eligibility.