Study on Sacituzumab Govitecan for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Resistant to Hormone and CDK4/6 Inhibitors

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as metastatic breast cancer, which has spread beyond the breast to other parts of the body. Specifically, it involves patients with HR-positive and HER2-negative breast cancer. These terms refer to the presence or absence of certain proteins that can affect how the cancer grows. The treatment being studied is a medication called sacituzumab govitecan, which is administered as an infusion into the bloodstream. This medication is designed to target and kill cancer cells.

The purpose of the study is to evaluate how the cancer responds to the treatment by analyzing certain biological markers, which are indicators of how the body is reacting to the medication. Participants in the study will receive the treatment and undergo a series of assessments to monitor changes in their cancer. These assessments will include biopsies, which are small samples of tissue taken from the body to be examined in a lab. The study will track the response of the cancer to the treatment over a period of time.

Throughout the study, researchers will collect data on how well the treatment works and any side effects that may occur. This information will help determine the effectiveness of sacituzumab govitecan in treating this type of breast cancer. The study aims to provide valuable insights into the potential benefits and risks of this treatment for patients with metastatic breast cancer.

1 Joining the study

Upon joining the study, a signed and dated informed consent form is required. This ensures understanding and agreement to participate in the study.

Eligibility is confirmed through a series of assessments, including the ability to safely perform a biopsy and normal organ and bone marrow function.

2 Initial biopsy

A biopsy is performed to collect a sample of the tumor tissue. This sample is evaluated for quality and suitability for the study.

The biopsy must be of good quality and is sent to a central lab for evaluation.

3 Treatment administration

The treatment involves the administration of sacituzumab govitecan, known as Trodelvy, which is given as an intravenous infusion.

The dosage is 200 mg, and the treatment is administered as a solution for infusion.

4 Follow-up biopsy

A follow-up biopsy is conducted 14 to 21 days after the initial treatment to assess the response.

The same location as the initial biopsy is used to ensure consistency in the evaluation.

5 End of treatment biopsy

At the end of the treatment period, another biopsy is performed to evaluate the final response to the treatment.

This biopsy is also conducted at the same location as the previous ones.

6 Assessment of treatment response

The primary goal is to evaluate changes in the CelTIL score, which is a measure of treatment response.

The CelTIL score is calculated based on tumor cellularity and the presence of tumor-infiltrating lymphocytes.

7 Monitoring and evaluation

Throughout the study, the overall response rate and other factors such as progression-free survival and duration of response are monitored.

Any adverse events or side effects are recorded and assessed for severity and relation to the treatment.

Who Can Join the Study?

Sign and date a written informed consent form before any study-specific procedures, sampling, and analyses.
Have a disease site that can safely undergo a biopsy, as assessed by the investigator, and be a candidate for a tumor biopsy according to the treating institution’s guidelines.
Be able to have a biopsy before starting treatment, and repeat it after 2 weeks and at the end of treatment at the same location. The tumor tissue must be of good quality and evaluated centrally for quality before enrollment. Certain types of biopsies are acceptable, such as core needle biopsies for deep tumor tissue or other specific types for different lesions. Some samples, like fine needle aspiration, are not acceptable.
Have normal organ and bone marrow function measured within 35 days before starting the study treatment. This includes specific levels for hemoglobin, neutrophil count, platelet count, bilirubin, liver enzymes, creatinine, serum albumin, and blood clotting times.
Have a life expectancy of at least 16 weeks.
If male or a female of childbearing potential, agree to use specific methods of contraception if engaging in heterosexual intercourse.
Be willing and able to follow the study’s requirements and restrictions.
Be male or female, pre/peri or postmenopausal, and at least 18 years old.
Have an ECOG performance status of 0 or 1, which is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Have breast cancer confirmed by tests, with evidence of locally advanced disease that cannot be removed by surgery or treated with radiation for a cure, or have metastatic disease.
Have HR+ (hormone receptor-positive) and HER2- (human epidermal growth factor receptor 2-negative) breast cancer, as determined by local testing, and not suitable for surgical therapy.
Have disease that is resistant to CDK4/6 inhibitors, meaning the disease returned during or within 12 months after the end of adjuvant treatment, or progressed during or within 6 months after the end of treatment for advanced/metastatic disease.
Have had no more than one prior systemic chemotherapy or antibody-drug conjugate (ADC) regimen for metastatic disease. Certain treatments for bone metastases and other therapies are not considered prior systemic chemotherapy treatments for advanced disease.
Show radiologic or objective evidence of disease progression on or after the last systemic therapy before starting the study treatment.
Have measurable or non-measurable disease that is evaluable, meaning it can be identified as target or non-target lesions by specific criteria.

Who Cannot Join the Study?

Patients who have had more than one previous treatment with chemotherapy or ADC (a type of targeted cancer treatment) for their cancer that has spread to other parts of the body.
Patients who have a type of breast cancer that is not resistant to ET (endocrine therapy) and CDK4/6 inhibitors. These are treatments that help control cancer growth.
Patients who are not male or women who are not pre or post-menopausal. This means the study is for men and women who have gone through menopause or are in the process of going through it.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Salut Sant Joan De Reus	Reus	Spain
Hospital Universitario Basurto	Bilbao	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hylnohfj Ukrluskcjchhy Dq Bpcqufa	Badajoz	Spain
Ifloyltz Cndjdc Desvqutzeeksofuiq	L'hospitalet De Llobregat	Spain
Hqakrhyz Uyjhedeiifhom Hfgzldfm Tltei y Phbqvs Ixekshjl Cgagxh dpgnkxadjqdqctesx (oxpt	Badalona	Spain
Hitbxxmi Vmji dpzleuky	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Sacituzumab Govitecan

Sacituzumab Govitecan is a medication used in this clinical trial for patients with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. 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 part works to kill the cancer cells. This trial aims to evaluate how effective this medication is by analyzing changes in a specific biomarker score after treatment.

Investigated diseases:

Hormone receptor positive HER2 negative breast cancer

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, such as the ducts or lobules. The disease may progress from a localized tumor to more advanced stages, where it spreads to nearby tissues or other parts of the body. Hormone receptor-positive (HR+) and HER2-negative breast cancer is a subtype that does not overexpress the HER2 protein but relies on hormones like estrogen to grow. This type can become resistant to hormone therapies and CDK4/6 inhibitors, which are common treatments. In advanced stages, it may require systemic chemotherapy or other targeted therapies.

Trial ID:

2023-505385-28-00

Protocol code:

SOLTI-2201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sacituzumab Govitecan for Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Resistant to Hormone and CDK4/6 Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?