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Neoadjuvant Sacituzumab Govitecan and Pembrolizumab for Patients with Clinical Stage II-III 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 studying triple-negative early breast cancer, a type of breast cancer that does not have the three common markers used to guide treatment. The purpose of the study is to compare two treatment approaches given before surgery: sacituzumab govitecan together with pembrolizumab, and standard chemotherapy.

The treatment is given as an intravenous infusion, which means it is delivered through a vein. The study looks at whether the new drug combination can help keep the cancer from coming back and whether it can remove all signs of invasive cancer in the breast and nearby lymph nodes before surgery. The course of the study includes treatment over a planned period, followed by surgery and later follow-up visits to monitor health over time.

Some medical terms used in the study include neoadjuvant, which means treatment given before surgery, and EFS, which means the length of time without a cancer-related event such as the cancer returning or worsening. The study also records side effects and overall health changes during follow-up.

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
Study treatment period
After you join the study, you receive one of the study treatments for triple-negative early breast cancer, which is breast cancer that does not have the three common receptors used to guide treatment.
One treatment option is sacituzumab govitecan given by intravenous infusion, which means medicine is given through a vein. the dose is 10 mg per kilogram of body weight.
The other treatment option is pembrolizumab given by intravenous infusion. the dose is 200 mg.
The source data do not state the exact frequency or total duration of administration for either medicine.
Step 2
Response checks during treatment
During the study treatment period, your cancer response is checked by physical examination and imaging tests.
The methods listed are palpation (feeling the breast or other area by hand), ultrasound, mammography, and mri (magnetic resonance imaging, a scan that uses magnets and radio waves to create detailed pictures).
Step 3
End of neoadjuvant treatment assessment
After completion of neoadjuvant treatment (treatment given before surgery), your health-related quality of life is assessed again. this means your overall well-being related to health is measured at that time.
For one study group, the trial compares side effects by looking at treatment-emergent adverse events (teae, side effects that appear during treatment), adverse drug reactions (adr, unwanted effects caused by a medicine), serious adverse drug reactions (sadr, serious unwanted effects caused by a medicine), and serious adverse events (sae, serious medical problems during the study).
Step 4
Follow-up period after treatment
After treatment, your progress is followed for up to 3 years from registration.
The study checks whether there is any invasive breast cancer event, death, another cancer, or, in one study group, local progression that prevents surgery.
The study also measures overall survival (os, time from first diagnosis to death), 3-year distant disease-free survival (ddfs, time without cancer spread to distant organs), 3-year recurrence-free survival (rfs, time without return of cancer), and 3-year local recurrence-free survival (lrfs, time without cancer returning in the breast or nearby area).

Who can join the trial?

25 criteria

Be at least 18 years old at the time of diagnosis.
Have triple-negative breast cancer, meaning the tumour tests ER 0%, PR 0%, and HER2 negative. ER and PR are hormone receptors, and HER2 is a protein tested on the cancer cells.
Or have TNBC-like breast cancer, meaning ER 10% or less, PR less than 10%, and HER2 negative. If the doctor plans to treat the cancer as triple-negative, a second pathology review is strongly recommended. Pathology means the study of tissue under a microscope.
Have a histologically confirmed cancer of the breast. Histologically confirmed means a tissue sample has been examined under a microscope and the diagnosis has been proven.
Have a unilateral breast cancer, meaning one breast is affected. Patients with cancer in both breasts, or with several tumour spots in the same breast, may still be included if there is one clear main tumour that will guide treatment and study evaluation, and all lesions are confirmed as triple-negative.
Have stage II or stage III disease at the start of the study. This means the cancer is locally advanced but not the earliest stage.
Have no distant metastasis (M0), meaning there is no clinical sign that the cancer has spread to distant organs.
Have a tumour tissue sample available for central pathology review, meaning the study team must be able to re-check the tissue sample in a central laboratory.
Have a good enough general physical condition to take part, with ECOG performance status 1 or less or Karnofsky score 80% or higher. These are scales that measure how well a person can do daily activities.
Be able and willing to give written informed consent before any study-specific procedures. This means the patient must sign a form showing they understand the study and agree to take part.
Be willing and able to follow the study rules, treatment plan, and follow-up visits, and be reachable for treatment and follow-up.
Have the required laboratory test results within the allowed time window. The exact details are defined in the study protocol.
Have a normal electrocardiogram (ECG) within 42 days before starting induction treatment. An ECG is a test that records the heart’s electrical activity.
For women who have not yet reached menopause, have a negative pregnancy test in urine or blood within 14 days before registration, and start appropriate contraception right away. Pregnancy testing must be repeated during the study as required.
If menopause status is unclear, meet the study’s age-related menopause rules: women under 50 years must have had no periods for at least 12 months after stopping hormone treatment and must have blood test results in the post-menopausal range; women 50 years or older must have had no periods for at least 12 months after stopping all hormone treatment.
If a woman is using hormone replacement therapy (HRT) and menopause status is uncertain, she must stop HRT and use an allowed contraceptive method until menopause is confirmed. HRT is medicine used to replace hormones after menopause.
If a woman can become pregnant and is sexually active with a male partner who has not been sterilized, she must use at least one highly effective contraceptive method from enrolment until 7 months after the last dose of study treatment.
Not breastfeed during the study and for 7 months after the last dose of study treatment.
Not donate eggs or have eggs collected for personal use from the time of randomization through the study treatment period and for at least 7 months after the final dose of study treatment.
If the participant is male, agree to use contraception during treatment and for at least 7 months after the last dose of study treatment, and not donate sperm during this time.
Have completed 9 to 12 weeks of neoadjuvant treatment before joining the study, with the last dose given less than 2 weeks ago. Neoadjuvant treatment means treatment given before the main surgery.
Have received the planned treatment with carboplatin and paclitaxel plus pembrolizumab, or a switch to nab-paclitaxel if paclitaxel was not tolerated. These are cancer medicines used before surgery.
If the cancer got worse during carboplatin/paclitaxel plus pembrolizumab treatment, the patient may still be allowed in cohort II after sponsor review, as long as at least 6 to 9 weeks of that treatment were given.
If pembrolizumab had to be stopped because of side effects, a medical reason, or a contraindication, the patient may still be included, even if pembrolizumab will no longer be given. A contraindication means a reason a treatment should not be used.
Have the cognitive and language skills needed to complete the quality-of-life questionnaires. Cognitive means thinking and understanding abilities.

Who cannot join the trial?

24 criteria

Allergy or hypersensitivity to any of the study drugs or to any ingredient in them, meaning a known reaction to the medicine or one of its components.
Not able to give informed consent, meaning the person cannot understand the study and agree to take part.
Peripheral neuropathy of grade 2 or higher, meaning nerve damage that causes at least moderate symptoms such as numbness, tingling, or pain.
Severe or important other medical problems that could interfere with the study treatment or participation, including recovery from major surgery, autoimmune disease (when the immune system attacks the body), known psychiatric illness or substance abuse disorder, acute cystitis (bladder infection), ischuria (inability to pass urine), or chronic kidney disease.
An infection that is not controlled and needs intravenous treatment, meaning medicine given through a vein, with antibiotics, antivirals, or antifungals.
Past or current pneumonitis (lung inflammation), hemolytic anemia (red blood cells break down too fast), myocarditis (heart muscle inflammation), sclerosing cholangitis (long-term bile duct disease), or exocrine pancreatic insufficiency (the pancreas does not make enough digestive enzymes).
A history of allogeneic stem cell transplant (stem cells from another person) or solid organ transplant (such as a kidney, liver, or heart transplant).
Active primary immunodeficiency, meaning the immune system is weak because of an inherited or ongoing immune problem.
Known HIV infection.
Active hepatitis B or hepatitis C infection, meaning an active virus infection of the liver.
Positive hepatitis B surface antigen test, which shows current hepatitis B infection.
Positive hepatitis B core antibody with detectable HBV DNA, meaning hepatitis B virus is active in the blood.
Positive hepatitis C antibody with detectable HCV RNA, meaning hepatitis C virus is active in the blood.
Received a live vaccine within 30 days before randomization, meaning a vaccine that contains a weakened live germ.
Being in the institution because of a court order or government order.
Another past cancer with a disease-free survival of less than 5 years, meaning less than 5 years without signs of that cancer, except for skin basal cell cancer that was fully treated or pTis of the cervix, meaning an early non-invasive cervical lesion.
Any past history of invasive breast cancer, meaning breast cancer that had spread into nearby breast tissue.
Previous or current treatment with cytotoxic agents for a non-cancer reason, meaning medicines that kill cells, unless the sponsor has clarified it is acceptable.
At the same time, using other experimental drugs, meaning medicines still being tested.
Participation in another interventional clinical trial within 30 days or within 5 drug half-lives, whichever is longer. A half-life is the time it takes for half of a drug to leave the body.
Current pregnancy.
Not using a highly effective non-hormonal contraceptive method during study treatment when pregnancy is possible for the patient or for a male patient's partner.
Breastfeeding.
Any reason that suggests the patient may not follow the study rules well, meaning a high risk of poor compliance.

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Verified sites

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

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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany
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Medical University Of Lausitz Carl Thiem
Cottbus, Germany

Trial locations

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Investigated drugs

Keytruda (pembrolizumab)
is an immunotherapy given by infusion into a vein. In this trial, it is used as part of the treatment plan to help the immune system find and attack cancer cells.
Trodelvy (sacituzumab govitecan)
is a cancer treatment given by infusion into a vein. In this trial, it is used together with Keytruda to treat the cancer before surgery and to help shrink or control the tumor.

What is already known about the treatment

pembrolizumab
Pembrolizumab is a medicine given by intravenous infusion, meaning it is delivered slowly into a vein by a healthcare professional. It is an approved and widely used cancer treatment in medical practice and research, especially for several types of solid tumors, including some breast cancers. It is used to help the body’s immune system attack cancer cells by blocking a signal called PD-1, which normally helps cancer hide from immune cells. This drug belongs to the group of immune checkpoint inhibitors, also known as anti-PD-1 monoclonal antibodies.
sacituzumab govitecan
Sacituzumab govitecan is also given by intravenous infusion as a powder that is prepared into a solution before use. It is an established cancer medicine in current medical use and is studied in the medical literature for hard-to-treat cancers, including triple-negative breast cancer. It is used to treat certain cancers by carrying a cancer-killing substance directly to tumor cells that have the Trop-2 target on their surface, helping damage those cells more specifically. This medicine is classified as an antibody-drug conjugate, which means it combines a targeting antibody with a chemotherapy drug.

Investigated diseases

Triple-negative early breast cancer - A type of breast cancer that does not have estrogen receptors, progesterone receptors, or HER2 protein on the cancer cells. It usually begins in the breast and may involve nearby lymph nodes at an early stage. The disease can grow into surrounding breast tissue and may spread to other parts of the body if it progresses.