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Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as triple-negative early breast cancer, which is considered to have a low risk of coming back after treatment. The study is comparing two treatment options: one using a medication called sacituzumab govitecan and the other combining sacituzumab govitecan with another medication called pembrolizumab. Sacituzumab govitecan is a type of drug that targets cancer cells, while pembrolizumab helps the immune system fight cancer.

The purpose of the study is to see if the combination of sacituzumab govitecan and pembrolizumab is more effective than sacituzumab govitecan alone. Participants in the study will receive one of these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 18 months, during which time participants will receive regular treatments and follow-up care to monitor their health and the effectiveness of the treatment.

Throughout the study, doctors will check for the absence of cancer in the breast and lymph nodes, which is known as a complete response. They will also track the participants' health over three years to see if the cancer stays away. The study aims to improve treatment options for people with this type of breast cancer and to increase the chances of long-term health and recovery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment involves two medications: sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is administered as a 200 mg powder for solution, and pembrolizumab is a 25 mg/mL concentrate for solution. Both are given through an intravenous infusion.
The patient will receive sacituzumab govitecan alone or in combination with pembrolizumab, depending on the assigned treatment group. The specific dosage and frequency will be determined by the study protocol.
Step 2
Monitoring and assessment
Throughout the treatment, regular monitoring will occur to assess the response to the medication. This includes clinical evaluations through palpation, ultrasound, and mammography.
Health-related quality of life will be evaluated at baseline and after 2, 4, and 6 cycles of treatment, if applicable. Further assessments will be conducted before surgery and every 6 months during follow-up until year 3, then yearly.
Step 3
Surgery and follow-up
After completing the treatment cycles, surgery may be performed to remove any remaining tumor tissue. The timing and type of surgery will be based on the treatment response and clinical guidelines.
Post-surgery, follow-up visits will continue to monitor for any signs of cancer recurrence and to evaluate overall survival and disease-free survival over a period of three years.
Step 4
Long-term evaluation
The study aims to track the 3-year invasive disease-free survival (iDFS) and other long-term outcomes such as overall survival and recurrence-free survival.
Patients will be observed for any invasive breast cancer events, secondary malignancies, or other health changes related to the treatment.

Who can join the trial?

28 criteria

The patient must have **triple-negative early breast cancer** with a low risk of coming back.
The cancer must be **ER + PR negative or low positive** (10% or fewer positive cells) and **HER2 negative**.
The patient must provide **written informed consent** before starting any study procedures.
The patient must be willing and able to follow the study's requirements and be available for treatment and follow-up.
**Laboratory requirements** include:
- White blood cells (leucocytes) at least 3.5 x 10⁹/L
- Neutrophils more than 1.5 x 10⁹/L
- Platelets at least 100 x 10⁹/L
- Hemoglobin at least 10 g/dL
- Alkaline phosphatase (AP) less than 5 times the upper limit of normal (ULN)
- AST and ALT (liver enzymes) less than 2.5 times ULN
- Total bilirubin less than 1 times ULN
- Creatinine less than 1.5 times ULN or clearance at least 30 mL/min if creatinine is higher
- **Clinical assessments** include:
  - Left ventricular ejection fraction (LVEF) within normal limits, measured by echocardiography
  - Normal electrocardiogram (ECG) within 42 days before treatment
  - Women under 50 are considered **post-menopausal** if they haven't had a period for 12 months after stopping hormone treatments and have certain hormone levels.
  - Women 50 and older are considered post-menopausal if they haven't had a period for 12 months after stopping all hormone treatments.
  - Women on hormone replacement therapy (HRT) must stop it to confirm post-menopausal status before joining the study.
  - Women who can have children and are sexually active must use a highly effective **contraception method** during the study and for 7 months after the last dose of the study drug.
  - Women must not **breastfeed** during the study and for 7 months after the last dose of the study drug.
  - Women must not donate or retrieve eggs during the study and for 7 months after the last dose of the study drug.
  - Men must agree to use contraception during the study and for 7 months after the last dose of the study drug and must not donate sperm during this time.
  - All patients must be at least 18 years old at diagnosis.
  - The patient must have a confirmed **unilateral, primary invasive carcinoma** of the breast.
  - The cancer must be at **clinical stage I** or certain stage II conditions.
  - There must be no evidence of **distant metastasis** (cancer spread to other parts of the body).
  - A **tumor block** must be available for central pathology review.
  - The patient must have a **Performance Status** of ECOG 1 or less, or KI 80% or more, which measures the patient's ability to perform daily activities.
  - Premenopausal patients must have a **negative pregnancy test** within 7 days before registration.

Who cannot join the trial?

4 criteria

Patients with medical conditions other than triple-negative early breast cancer with low risk for recurrence cannot participate. This means the cancer does not have certain receptors that are common in other breast cancers.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not meet the gender requirements of the study cannot participate. The study may be open to both males and females, but specific criteria must be met.
Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who might be at a higher risk of harm or exploitation in a study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Verified
Essen, Germany

Trial locations

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Investigated drugs

Sacituzumab Govitecan
is a medication used in this trial to treat low-risk, triple-negative early breast cancer. It is an antibody-drug conjugate, which means it combines an antibody with a chemotherapy drug. The antibody part helps the medication find and attach to cancer cells, while the chemotherapy drug works to kill these cells.
Pembrolizumab
is another medication used in this trial, often referred to as an immunotherapy drug. It helps the body's immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with Sacituzumab Govitecan to see if the combination is more effective than using Sacituzumab Govitecan alone.

What is already known about the treatment

Sacituzumab Govitecan
This medication is administered intravenously and is currently being studied for its effectiveness in treating triple-negative early breast cancer with a low risk of recurrence. It is an antibody-drug conjugate that targets a protein called Trop-2, which is often found on cancer cells, delivering a chemotherapy agent directly to the tumor. Sacituzumab Govitecan is classified as an antineoplastic agent and is being evaluated for its potential to improve patient outcomes in clinical trials.
Pembrolizumab
This medication is also administered intravenously and is being tested in combination with Sacituzumab Govitecan for the treatment of triple-negative early breast cancer. Pembrolizumab is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells. It is classified as an immunotherapy and is widely studied for its role in enhancing the body's natural defenses against cancer.

Investigated diseases

Triple-negative early breast cancer with low risk for recurrence – This type of breast cancer is characterized by the absence of estrogen receptors, progesterone receptors, and excess HER2 protein. It is considered "triple-negative" because it does not respond to hormonal therapy or therapies that target HER2 receptors. This form of cancer tends to grow and spread more quickly than other types of breast cancer. However, in cases with a low risk for recurrence, the cancer is less likely to return after initial treatment. The progression of the disease can vary, but it typically involves the growth of cancerous cells in the breast tissue and potentially spreading to nearby lymph nodes. Early detection and monitoring are crucial for managing the disease effectively.