Study Comparing Sacituzumab Govitecan to Physician’s Choice Treatment for Patients with Advanced Triple-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as triple-negative breast cancer (TNBC). This form of cancer does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2. The study is specifically looking at patients with advanced stages of this cancer, either locally advanced, inoperable, or metastatic, meaning it has spread to other parts of the body. The trial involves a medication called sacituzumab govitecan, which is being compared to other treatments chosen by doctors. Sacituzumab govitecan is a type of treatment known as an antibody-drug conjugate, which combines an antibody with a drug to target cancer cells more precisely.

The purpose of the study is to compare the effectiveness of sacituzumab govitecan with other treatments in patients who have not received previous treatment for their advanced cancer or who have been treated with certain immune therapies. The study will involve administering the treatments through an intravenous infusion, which means the medication is given directly into a vein. Patients will be monitored over a period to see how their cancer responds to the treatment. The study will also look at how long patients live and how their quality of life is affected by the treatment.

Participants in the study will receive either sacituzumab govitecan or a treatment chosen by their doctor, which may include medications like paclitaxel, gemcitabine, or carboplatin. These are all chemotherapy drugs that work by stopping the growth of cancer cells. The study aims to provide more information on the best treatment options for patients with this challenging type of breast cancer. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments being studied.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

A baseline biopsy may be required if archival tissue is not available. This procedure must be performed before the first dose of study treatment.

2 randomization

Participants are randomly assigned to receive either sacituzumab govitecan or a treatment chosen by the physician from a list of approved options.

3 treatment administration

The treatment involves intravenous infusions of the assigned medication.

Medications include paclitaxel, gemcitabine, sacituzumab govitecan, carboplatin, and paclitaxel albumin-bound.

The specific dosage, frequency, and duration depend on the treatment plan determined by the physician.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment and any side effects.

Assessments include imaging tests like CT or MRI to measure disease progression.

5 end of treatment

The treatment continues until disease progression, unacceptable side effects, or other criteria for discontinuation are met.

Final assessments are conducted to evaluate the overall response to the treatment.

6 follow-up

After the treatment phase, follow-up visits are scheduled to monitor long-term health and any delayed effects of the treatment.

Who Can Join the Study?

  • Must be a female or male patient, 18 years or older, able to understand and give written consent.
  • Blood clotting tests (INR/PT and PTT or aPTT) should be within normal limits unless on blood-thinning medication.
  • If sexually active, must agree to use specific birth control methods.
  • Patients with HIV must be on HIV medication, have a stable and well-controlled infection, and meet specific health criteria.
  • Must have a specific type of breast cancer called triple-negative breast cancer (TNBC), which means the cancer does not have certain receptors (ER, progesterone receptor, and HER2).
  • Must have a tumor that is either PD-L1 negative or PD-L1 positive and previously treated with a specific type of medication if applicable.
  • Must have completed treatment for earlier stages of breast cancer, with a certain time elapsed since treatment.
  • Must have measurable disease as determined by specific imaging tests like CT or MRI.
  • Must provide a tumor sample for testing, either from a recent biopsy or stored tissue.
  • Must have a good general health status, as measured by a specific performance score.
  • Must have a life expectancy of at least 3 months.
  • Must have recovered from any major surgery for at least 2 weeks.
  • Must have adequate blood cell counts without recent support from transfusions or growth factors.
  • Must have proper liver function, with specific limits on liver enzymes and proteins.
  • Must have a certain level of kidney function, measured by creatinine clearance.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with PD-L1-negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer that was previously treated with an anti-PD-(L)1 agent in a curative setting. Metastatic means the cancer has spread to other parts of the body. PD-L1 is a protein that can affect the immune system’s ability to fight cancer. Triple-negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Jean Perrin Clermont Ferrand France
Frisius Heerenveen The Netherlands
Medisprof S.R.L. Cluj Napoca Romania

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Hospital Olomouc Olomouc Czechia
Centre De Cancerologue Du Grand Montpellier Montpellier France
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Ceeqosegg Uwlffjpenytjcm Sylkznicm Woluwe-Saint-Lambert Belgium
Unqwmfnncb Ol Dtpyeazw Debrecen Hungary
Hzdlnkvb Vltc dytgreyz Barcelona Spain
Badleguvh Ucjkmu Uugjd Kteqgc Budapest Hungary
Hemzuprw Uncpodhfbytfh dq A Capijt A Coruna Galicia Spain
Vrrlfz dkj Rkzsm Uvlmfuwvsy Hujetsnx Sevilla Spain
Ukejtinalt Hdfyllkd Cywknhn Cologne Germany
Uxvvecqsvuppkzadmxezy Ttuadyrgj Afq Tuebingen Germany
Hgrljznn Umrywlbkzorjs Fcxvdkrug Jtonjqn Dpbr Madrid Spain
Fqhuclyh Nuklvabhm Khwqyosxw Vzobhbeoo Prague Czechia
Inbsf Ooiutbhg Phavsdkwgsk Sfw Mvugxeh Genoa Italy
Ufytowibgmwftflluorgy Hrntywiita Aqk Heidelberg Germany
Ahfzzxt Ovkkaugrmlphovwkpqljecsyb Mklacdkf Dyrme Cxdyhx Novara Italy
Vekvaoipq Fnukeweb Ntnjoqvns V Pswdw Prague Czechia
Uqsbufphjy Hndrjuto Mxtbxcklqi Maastricht The Netherlands
Afieaso Uwmmg Spbmthxso Ldkfbi Dg Bbwbsia Bologna Italy
Hbwporfw Dx Lx Sacge Caqp I Sonp Pht Barcelona Spain
Ukkfcqldas Mtslfpi Cocwqx Hyjcruoyfuhcpjaev Hamburg Germany
Umnpgwprvt Dobed Swiuj Do Rrem La Svyvtmyd Rome Italy
Ozebdtxrvtvbug Ljan Gpcd Linz Austria
Ummicyajphpj Muopnue Ctxqtdy Gjqutuchq Groningen The Netherlands
Abtahjea Zryosbslct Kpnvh Brasschaat Belgium
Hgmmip Kdrdhvpg Bqwkdtjknrr Geli Berlin Germany
Vimvc Uvnrzsmzkzkp Bvzxtia Jette Belgium
Uhphmkjvtm Disas Scksr Dh Bghfutz Brescia Italy
Irpzafdz Tnxlrb Bhcd Gvhcbblt Pnvkd Io Bari Italy
Cuugzl Hlbxsnlhacq Umnizuknxddfn Dckfxp Gbrqxuy Svsudsxnhshbvoonkgryabgfme Namur Belgium
Fkcwwcrnxm Iqhsb Szp Ggaxtky Dvz Tbhvcky Monza Italy
Fdpvhkllos Ivpaereiwv Iinhkbec Nwpsfzxtkcd Biyas Milan Italy
Heirxasm Unysiydtiuedm Vtgexw Ds Lb Vmqsiltv Malaga Spain
Izrizltc Obcdpefwgx Vshndf Padua Italy
Cuwvnvf Dp Owsxmbmqc Ss Njyscuur Splcds Craiova Romania
Nxjudggh Owdjcnto Inbvclpka Bratislava Slovakia
Sjmcungj Ckrlia Fatccebdlfh Bucharest Romania
Akmrnfz Uwg Thcjskl nttb ozytw Leghorn Italy
Fnpsqxhf Tqfrsditcog nmddwydre Prague Czechia
Cwiwfr Dq Lnrxz Cwznau Lb Casndm Eyxhso Mihugyl Rennes France
Badehakq Utfqteeynk Hbakauxo Coypbf Besançon France
Auhygdurzo Medulzi Hnwikmfr Lecco Italy
Hkmvqlxb Ujamcncjjxad Aneuc Dy Vsyjfavj Db Lz Gmzqvkrw Tcqdspccmrg Dm Lglayb Lleida Spain
Nusrhmyb Ivvgzuuj Oeigwcvhm Iyr Mepck Ssvarlgcynllqefpbvimoqrbmxgd Ikgsfkfp Bmutvleu Cracow Poland
Hlbplzgr Gmvjzeg Ubtnagaxtbgnr Mpkgahh Mbcvhoap Murcia Spain
Oximoorm Cnvuktd Ommywvcuq Ikw Pgsnj Tbywkbaj Kzsipwuubfaxlk W Omyti Stbcyvozllf Pgrmajmfl Zjcevc Oozdgu Zrdswvspur Opole Poland
Oyzmvapwpnz Ulocx Ss Agkutxl sjgljz Bratislava Slovakia
Haqefmwb Utsrloonxzrma Bhcrcac Bilbao Spain
Mu Aqxpgmfj Ccagfp Cumfgc Madrid Spain
Owxorgaz Gfytkqlr Pjyffpdusoq Dl Mfyclasr Macerata Italy
Ndkqlrpqa Nh Oefnku Mfltx Ngmr Partizanske Slovakia
Kwplxgao Enykrfzkkksfkhuerjkpqdda Hmbneysudqmacrxih Essen Germany
Mwczzdzou Syages Cluj Napoca Romania

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
20.07.2022
Belgium Belgium
Not recruiting
20.07.2022
Czechia Czechia
Not recruiting
20.07.2022
France France
Not recruiting
20.07.2022
Germany Germany
Not recruiting
20.07.2022
Hungary Hungary
Not recruiting
20.07.2022
Italy Italy
Not recruiting
20.07.2022
Poland Poland
Not recruiting
20.07.2022
Romania Romania
Not recruiting
20.07.2022
Slovakia Slovakia
Not recruiting
20.07.2022
Spain Spain
Not recruiting
20.07.2022
The Netherlands The Netherlands
Not recruiting
20.07.2022

Trial locations

Sacituzumab Govitecan is a medication being studied for its effectiveness in treating patients with a specific type of breast cancer known as triple-negative breast cancer. This type of cancer does not have certain receptors, making it more challenging to treat. Sacituzumab Govitecan is designed to target and deliver chemotherapy directly to the cancer cells, potentially reducing the cancer’s growth and spread. The trial aims to see how well this medication works compared to other treatments chosen by doctors.

Investigated Diseases:

Metastatic Triple-Negative Breast Cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease can spread to other parts of the body, such as the bones, liver, or lungs, which is referred to as metastasis. Patients with this cancer may experience symptoms like lumps in the breast or underarm, changes in breast shape, or skin dimpling. The progression of the disease can vary, with some experiencing rapid advancement while others may have a slower progression. Treatment typically focuses on managing symptoms and slowing the spread of the disease.

Trial ID:
2023-504195-14-00
Protocol code:
GS-US-592-6238
NCT ID:
NCT05382299
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Neoadjuvant Sacituzumab Govitecan and Pembrolizumab for Patients with Clinical Stage II-III Triple-Negative Early Breast Cancer

    Recruiting

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    Germany Poland
  • Study of pembrolizumab, capecitabine, or olaparib in patients with early-stage triple negative breast cancer and remaining disease after initial treatment

    Recruiting

    3 1 1 1
    Investigated Diseases:
    The Netherlands