RecruitingNCT06966700ClinicalTrials.gov record

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Breast Neoplasms · Triple Negative Breast Neoplasms · HR Low-Positive/HER2-Negative Breast Neoplasms

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 2400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Researchers are looking for new ways to treat types of breast cancer that are both:

High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:

Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:

cT1c, N1-N2
cT2, N0-N2
cT3, N0-N2
cT4a-d, N0-N2
The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
Demonstrates adequate organ function.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I inhibitor-containing ADC.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Uncontrolled systemic disease.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

sac-TMT

Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.

Biological: Sacituzumab tirumotecan · Biological: Pembrolizumab · Drug: Rescue Medication · Drug: Carboplatin · Drug: Paclitaxel · Drug: Doxorubicin · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Capecitabine · Drug: Olaparib

Chemotherapy

Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.

Biological: Pembrolizumab · Drug: Rescue Medication · Drug: Carboplatin · Drug: Paclitaxel · Drug: Doxorubicin · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Capecitabine · Drug: Olaparib

Sacituzumab tirumotecan BIOLOGICAL

IV infusion

Pembrolizumab BIOLOGICAL

IV infusion

Rescue Medication DRUG

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

Carboplatin DRUG

IV infusion

Paclitaxel DRUG

IV infusion

Doxorubicin DRUG

IV infusion

Epirubicin DRUG

IV infusion

Cyclophosphamide DRUG

IV infusion

Capecitabine DRUG

Oral tablet

Olaparib DRUG

Oral tablet

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery

Time frame: Up to approximately 30 weeks

pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

Event-Free Survival (EFS)

Time frame: Up to approximately 92 months

EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.

Secondary measures

Overall Survival (OS)

Time frame: Up to approximately 115 months

OS is defined as the time from randomization to death due to any cause.

Percentage of Participants with pCR with No Ductal Carcinoma in Situ (pCR-no DCIS) at the Time of Definitive Surgery

Time frame: Up to approximately 30 weeks

pCR-no ductal carcinoma in situ (DCIS) (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.

Percentage of Participants with pCR at the Time of Definitive Surgery (High-risk, early-stage, TNBC subset)

Time frame: Up to approximately 30 weeks

Event-Free Survival (EFS) (High-risk, early-stage, TNBC subset)

Time frame: Up to approximately 92 months

EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first. The EFS will be presented for the subset of participants who enrolled with high-risk, early-stage, TNBC.

Overall Survival (OS) (High-risk, early-stage, TNBC subset)

Time frame: Up to approximately 115 months

OS is defined as the time from randomization to death due to any cause.

Distant Progression or Distant Recurrence-Free Survival (DPDRFS)

Time frame: Up to approximately 92 months

DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed by investigator, or death due to any cause, whichever occurs first.

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score