Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with HR+/HER2- Metastatic Breast Cancer After Endocrine Therapy

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2. The study involves patients who have advanced or metastatic breast cancer, meaning the cancer has spread beyond the breast to other parts of the body, and who have already received treatment with hormone therapy.

The main treatment being studied is a medication called sacituzumab govitecan, which is also known by its code name IMMU-132. This medication is an antibody-drug conjugate, which means it combines an antibody with a drug to target cancer cells more precisely. The study will compare the effects of sacituzumab govitecan with other treatments chosen by the patient’s doctor, which may include medications like capecitabine, nab-paclitaxel, or paclitaxel. These are all types of chemotherapy drugs used to treat cancer.

The purpose of the study is to evaluate how well sacituzumab govitecan works compared to the other treatments in terms of delaying the progression of the disease. Patients participating in the study will receive either sacituzumab govitecan or one of the other treatments, and their health will be monitored over time to assess the effects of the treatment. The study will involve regular check-ups and assessments to track the progress of the cancer and any side effects of the treatments. The study aims to provide valuable information that could help improve treatment options for patients with this type of breast cancer in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either sacituzumab govitecan or a treatment chosen by your physician. This is to compare the effects of the different treatments on your condition.

2 treatment administration

If assigned to sacituzumab govitecan, you will receive it as an intravenous infusion. This means the medication will be given through a vein in your arm. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

If assigned to the treatment of your physician’s choice, you may receive medications such as capecitabine or paclitaxel. Capecitabine is taken orally in the form of film-coated tablets, while paclitaxel is administered as an intravenous infusion.

3 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This may include physical examinations, blood tests, and imaging studies such as CT or MRI scans.

Your healthcare team will assess the progression of your disease and any side effects you may experience. This information is crucial for determining the effectiveness and safety of the treatment.

4 completion of the study

The study is expected to continue until December 2028. Your participation may end earlier if you experience significant side effects, if your disease progresses, or if you choose to withdraw from the study.

Upon completion, you will have a final assessment to evaluate your overall health and the outcomes of the treatment you received.

Who Can Join the Study?

  • Must be assigned male or female at birth and be 18 years of age or older.
  • Must be able to understand and give written informed consent.
  • Must have completed any cancer treatment at least 14 days before joining the study. Any side effects from previous treatment should be resolved or stable.
  • If you have HIV, you must be on antiretroviral therapy (ART) and have a well-controlled infection. This means:
    • Your CD4+ T-cell count should be at least 350 cells/mm3.
    • Your HIV RNA level should be below 50 copies/mL for at least 12 weeks before joining the study.
    • You should have been on a stable ART regimen for at least 4 weeks before joining the study.
    • Your ART regimen should not interfere with the study medication.
  • Must meet organ function requirements as per the study protocol.
  • Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use specified methods of contraception.
  • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest.
  • Must have a life expectancy of at least 3 months.
  • Must be willing and able to follow the study requirements and restrictions.
  • Must have measurable disease according to specific criteria used in the study.
  • Must provide a tumor tissue sample for testing, preferably from a locally recurrent or metastatic site.
  • Must have documented evidence of HR+ metastatic breast cancer, confirmed by a recent tumor biopsy.
  • Must have documented evidence of HER2- status according to specific guidelines.
  • Must have documented disease progression by CT or MRI during or after the most recent therapy.
  • Must be a candidate for the first chemotherapy in the locally advanced or metastatic setting.
  • Must be eligible for specific chemotherapy drugs like capecitabine, nab-paclitaxel, or paclitaxel.
  • Must have experienced disease progression on at least two previous lines of endocrine therapy (ET) in the metastatic setting.
  • May have received prior targeted therapies but can no longer be candidates for additional endocrine treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have not received a treatment based on hormones for their breast cancer.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment within a certain time frame before the study starts.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain infections that are not well controlled.
  • Patients with a history of drug or alcohol abuse that could affect their participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medizinische Universitaet Innsbruck Innsbruck Austria
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Henri Becquerel Rouen France
General University Hospital Of Larissa Larissa Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Champalimaud Clinical Centre Lisbon Portugal
Cliniche Gavazzeni S.p.A. Bergamo Italy
Hopital Prive Des Cotes D’armor Plerin France
Lux Med Onkologia Sp. z o.o. Warsaw Poland
University Hospital Olomouc Olomouc Czechia
Polyclinique De Limoges Limoges France
Istituto Oncologico Veneto Padua Italy
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Algemeen Ziekenhuis Klina Brasschaat Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Heidelberg University Mannheim Germany
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Hospital Universitario De Jaen Jaen Spain
Humanitas Istituto Clinico Catanese S.p.A. Misterbianco Italy
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Basurto Bilbao Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
MD Anderson Cancer Center Madrid Spain
Instytut Msf Sp. z o.o. Lodz Poland
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Krajska Nemocnice T Bati a.s. Zlin Czechia
Multiscan s.r.o. Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Iinzpadz Rkrbknlt Dq Clrcpd Di Mnffozgazkq Montpellier France
Btbwvhhuosi Vhbwzwfno Ozjzszorpeib Kecskemet Hungary
Fnivlmwa navdodjtv Mcolo a Hlwucms Prague Czechia
Bvquraaq Ukemcrnzdr Hghqgpra Cmktqo Besançon France
Ajkwhh Mpvauez Cstyjo Szja Thessaloniki Greece
Kuoqkdml dgl Uuqwrvhnhkzk Mmspfoua Aal Munich Germany
Awsrafx Uvoxh Srxamfrxg Lmvduo Dl Bbmuxak Bologna Italy
Axjolxy Hxevmsmg Athens Greece
Cgmxdc Ltcf Byrxfq Lyon France
Ufffryapir Dpkmt Sjtga Di Rchc La Ssdyolum Rome Italy
Uendpljhsl Meqyr Ggiwsco Oq Ctetsiodi Catanzaro Italy
Hivbtwkv Vcty dsoinxkt Barcelona Spain
Inxjcxxj Pgkfrtrxveugzkq Cvwqud Cksgvv Marseille France
Cxjwlm Osrvx Lddxtnl Lille France
Isyctmnq Chmha Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.08.2023
Belgium Belgium
Not recruiting
22.08.2023
Czechia Czechia
Not recruiting
22.08.2023
France France
Not recruiting
22.08.2023
Germany Germany
Not recruiting
22.08.2023
Greece Greece
Not recruiting
22.08.2023
Hungary Hungary
Not recruiting
22.08.2023
Italy Italy
Not recruiting
22.08.2023
Poland Poland
Not recruiting
22.08.2023
Portugal Portugal
Not recruiting
22.08.2023
Spain Spain
Not recruiting
22.08.2023

Trial locations

Sacituzumab Govitecan is a type of medication used in cancer treatment. It is designed to target and attach to specific proteins found on the surface of cancer cells. Once attached, it delivers a powerful drug directly into the cancer cell, which can help to stop the cancer from growing and spreading. This medication is being studied to see how well it works compared to other treatments chosen by doctors for patients with a specific type of breast cancer.

Hormone Receptor-Positive, HER2-Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors for estrogen or progesterone, but lacks the human epidermal growth factor receptor 2 (HER2). It typically progresses by using hormones to fuel its growth, which can lead to the cancer spreading to nearby tissues or other parts of the body. The disease may initially respond to hormone-blocking treatments, but over time, it can become resistant and continue to grow. As it advances, the cancer can invade local structures such as the chest wall or lymph nodes. In metastatic cases, it can spread to distant organs like the bones, liver, or lungs. The progression of this cancer is often monitored through imaging and clinical evaluations to assess changes in tumor size and spread.

Trial ID:
2022-502593-17-00
Protocol code:
GS-US-598-6168
Trial Phase:
Therapeutic confirmatory (Phase III)

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