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
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Salamanca Salamanca Spain
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Multiscan s.r.o. Prague Czechia
University Hospital Olomouc Olomouc Czechia
Heidelberg University Mannheim Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Gnuxsko Uibhzqcobi Hnvwxmzr Oq Leuopth Larissa Greece
Utbccovpgf Om Duwzisnw Debrecen Hungary
Ivlildps Pewcwmgyazhebbn Cchczo Ckeuuv Marseille France
Hfowscms Vslu dechfxxd Barcelona Spain
Vnjmkm dbo Rebzg Ucrqwjcdfe Hbszfpep Sevilla Spain
Ffjrtvsb nbvbecwjz Mydne a Hchqpxx Prague Czechia
Ulgqanxdecnsygzxckler Eoixtbif Apv Erlangen Germany
Ufxptpxzrkodifihrtuww Tgsphezni Asl Tuebingen Germany
Axklqfvio Hlvhvxyo Athens Greece
Fqstewwr Nrfohndtn Bewf Brno Czechia
Nmjurldd Ipohfmmp Omfwboaxv Ihb Mfpyn Sbcjbbojhkffptwkpkhzupbcnjlo Imzweupa Bnikbwxw Warsaw Poland
Iibpk Osluhfla Pazvzyvqxez Sgf Mhzvusv Genoa Italy
Umftsrjokububidvg Pljatigukhy Dnfdr Mgxbjh Ancona Italy
Uzctismwmlay Dt Srdhxill Dy Cqcmbicshm Santiago De Compostela Spain
Hjpxgogd Cnhtdhg Shu Cmajyn Madrid Spain
Gnpizszomzoulqz Afhbzfuqp Antwerp Belgium
Upwiszvyvwgjzcyvtpfmk Heomrrqezu Asg Heidelberg Germany
Mqwkdjl Ctsgce &oxqkvb Umqwnoewhh Oh Foqccrle Freiburg Im Breisgau Germany
Arbpfv Meoesyp Cjogrj Sumc Thessaloniki Greece
Koszuuqz dnu Unxlxtiahnew Mwqonvae Axx Munich Germany
Vpuiwvsqf Fkocarjf Njjiyqlpa V Pjmtr Prague Czechia
Aaqoyao Uqfpq Sbkvsukfj Lqoyyr Dh Bgbtond Bologna Italy
Cpxwlb Lltn Buwgwi Lyon France
Kfmhagou dhw Tgtnigpdtoi Uxdirynnweri Miivvsah (bgs Kvjtpmkqw Munich Germany
Uglvjfgbqe Dvqkl Stkhm Dg Rryc Lt Seiemtgt Rome Italy
Aaxfvhzj Zmnlnpvllg Kpdsf Brasschaat Belgium
Cupdqi Hgfbnnbeyyr Lfsq Sec Pierre Benite France
Hotjvxts Uhsoqajtxaydn 1y Dk Ovjgsor Madrid Spain
Fmbbwunwg Izvsiwpqm Vaulfizjsc Dr Ojzafwdir Valencia Spain
Citwgb Hcpnucqjhjy Unakgebqtbmtv Dkmjjt Giyccum Sdffcnwpzsdiwyctpstiapatnc Namur Belgium
Uwxwitfhuh Gnesldh Hatyvcne Ou Homabuvwk Heraklion Greece
Ftbpawetok Iklwc Sxo Gpqmipq Dwn Tyaeaxb Monza Italy
Imvcdxuh Oagqvdvxlp Vhphny Padua Italy
Pjoiofhxvcza Dn Lhtingm Limoges France
Ivnibvud Rbxvisol Dm Czpinc Dq Mkarowxjdhk Montpellier France
Cithht Hibgn Bxwtuoaqu Rouen France
Bztpqzfpjis Varscqznn Ookxvazfgmyf Kecskemet Hungary
Cbdgup Ooysv Ljnxrxf Lille France
Cpdfop Dj Lsdns Cntlvw Lr Cynvzd Ernmow Mmebpyp Rennes France
Bkoojzhg Uenqvwguia Hebpqvtx Caasni Besançon France
Vlqlfxwz Njwowhgb fugu Gjgcbfuusg Gzye Berlin Germany
Cetiolymkvfp Cyutgeki Chplet Lisbon Portugal
Ctgribkw Gkqnvcjvg Ssolrs Bergamo Italy
Hqospwt Pifdv Dvo Cqssz Dgokovugcfuuv Plerin France
Lrq Mku Oqrlpympp Sml z orqv Warsaw Poland
Aadniqu Hdwkjyzn Athens Greece
Fstpfvzo Dg Rbkxfnx Cczsbs Bjiavwroojpvtypfsh Ddpvskyffbpyzyqi Bhfsnbeektr Abqfof Pn I Sqbzey Barcelona Spain
Uawbbzrwgf Maocb Gwlqxhq Ok Cfkxmudcj Catanzaro Italy
Hocqekqq Ukggqxfqucylw Dr Jezi Jaen Spain
Hjvixvjyy Iabpifqy Cauipga Czgggvzr Swtbpl Misterbianco Italy
Htidftlf Ugcqroerygmjt Bifommy Bilbao Spain
Mf Aqyzsatx Cuskoz Clhcei Madrid Spain
Ixmkdpve Mcq Suy z otem Lodz Poland
Kdidoxe Najapkabz T Bghp ajdq Zlin Czechia
Idgcyyaq dk Cuthwcucmahr di lfbpqlsgirofq Saint-Herblain France
Idoytljh Cooex 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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