A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

New breast cancer trial tests targeted therapy with immunotherapy and chemo

NCT: NCT06966700 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2025-06-30 · Est. Completion: 2034-12-29

Plain English Summary

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms. This study tests a new drug combination including sacituzumab tirumotecan, a targeted therapy, along with pembrolizumab (an immunotherapy) and chemotherapy. It is for individuals with high-risk, early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer. Participants will receive either the new drug combination or standard chemotherapy with pembrolizumab, and will undergo surgery. Standard treatment options for this type of breast cancer include chemotherapy, radiation, surgery, and hormone therapy, depending on the cancer's characteristics. The trial aims to enroll 2400 participants.

Official Summary

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 Can Participate

Here is what you need to know about eligibility for this trial. You may be eligible if you have high-risk, early-stage breast cancer that has not spread to distant parts of the body and have not received prior treatment for this specific cancer. The cancer must be either triple-negative or hormone receptor-low positive/HER2-negative. You must be able to have a biopsy and have good general health, as indicated by your ECOG performance status. You cannot join if you have metastatic (Stage IV) breast cancer, have already received treatment for this breast cancer, or have certain other medical conditions. This trial is studying Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will measure if the new treatment helps remove all cancer cells from the breast and lymph nodes before surgery, and if it helps patients live longer without their cancer coming back. The specific primary outcome measures are: Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery (Up to approximately 30 weeks); Event-Free Survival (EFS) (Up to approximately 92 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to find a more effective treatment for aggressive early-stage breast cancers that have a high chance of returning, potentially filling a gap in current treatment options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in early-stage breast cancer, with a large enrollment suggesting strong interest from both patients and the sponsor (Merck), potentially indicating a favora Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 2400 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you, what the potential benefits and risks are, and what the treatment schedule will be. Participation involves receiving study treatments (infusions) and undergoing surgery. You will have regular check-ups and tests to monitor your health and the cancer's response. Be prepared for potential side effects from the study medications and chemotherapy, and discuss any concerns with your healthcare team. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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 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 treatment randomization.
* 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 randomization.
* 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 or has current pneumonitis/interstitial lung disease.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06966700?

NCT06966700 is a Phase 3 INTERVENTIONAL study titled "A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 2400 participants.

What conditions does NCT06966700 study?

This trial investigates treatments for Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms. The primary condition under study is Breast Neoplasms.

What treatments are being tested in NCT06966700?

The interventions being studied include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Rescue Medication (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG). IV infusion

What does Phase 3 mean for NCT06966700?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06966700?

This trial is currently "Recruiting." It started on 2025-06-30. The estimated completion date is 2034-12-29.

Who is sponsoring NCT06966700?

NCT06966700 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06966700?

The trial aims to enroll 2400 participants. The trial is currently recruiting and accepting new participants.

How is NCT06966700 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06966700?

The primary outcome measures are: Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery (Up to approximately 30 weeks); Event-Free Survival (EFS) (Up to approximately 92 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06966700 being conducted?

This trial is being conducted at 20 sites, including Gilbert, Arizona; Phoenix, Arizona; Tucson, Arizona; Burbank, California and 16 more sites (United States).

Where can I find official information about NCT06966700?

The official record for NCT06966700 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06966700. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06966700 testing in simple terms?

This study tests a new drug combination including sacituzumab tirumotecan, a targeted therapy, along with pembrolizumab (an immunotherapy) and chemotherapy. It is for individuals with high-risk, early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer.

Why is this trial significant?

This trial aims to find a more effective treatment for aggressive early-stage breast cancers that have a high chance of returning, potentially filling a gap in current treatment options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06966700?

Common side effects may include fatigue, nausea, diarrhea, low white blood cell counts, and hair loss. More serious risks can include lung problems (like inflammation), severe allergic reactions, and damage to nerves. There is a risk that the treatment may not be effective or could cause side effects that are difficult to manage. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06966700?

Ask your doctor if this trial is a good fit for you, what the potential benefits and risks are, and what the treatment schedule will be. Participation involves receiving study treatments (infusions) and undergoing surgery. You will have regular check-ups and tests to monitor your health and the cancer's response. Be prepared for potential side effects from the study medications and chemotherapy, and discuss any concerns with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06966700 signal from an investment perspective?

This trial targets a significant unmet need in early-stage breast cancer, with a large enrollment suggesting strong interest from both patients and the sponsor (Merck), potentially indicating a favora This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either the new drug combination or standard chemotherapy with pembrolizumab, and will undergo surgery. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.