Study Comparing Trastuzumab Deruxtecan with Chemotherapy for Patients with HER2-Low, Hormone Receptor Positive Breast Cancer After Endocrine Therapy Progression

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as HER2-low, hormone receptor positive breast cancer. This type of cancer has progressed despite treatment with hormone therapy in patients with advanced or metastatic disease. The study will compare the effects of a new treatment called Trastuzumab Deruxtecan (also known as DS-8201a or T-DXd) with other chemotherapy options chosen by the doctors involved in the study.

The purpose of the study is to evaluate how well Trastuzumab Deruxtecan works compared to the other chemotherapy treatments. Participants will receive either Trastuzumab Deruxtecan or a chemotherapy treatment selected by their doctor. The chemotherapy options may include medications such as Paclitaxel, Abraxane (a form of paclitaxel), or Capecitabine. These treatments are given through an infusion, which means they are administered directly into the bloodstream through a vein, or taken orally in the case of Capecitabine.

The study will monitor participants over a period of time to observe the effects of the treatments on their cancer. The main focus will be on how long the cancer stays under control and the overall survival of the participants. The study will also look at the safety and side effects of Trastuzumab Deruxtecan compared to the other chemotherapy treatments. Participants will be closely monitored by their healthcare team throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical history related to breast cancer.

The study focuses on patients with HER2-low, hormone receptor-positive breast cancer that has progressed after endocrine therapy.

2 treatment assignment

Participants are randomly assigned to receive either trastuzumab deruxtecan or a chemotherapy treatment chosen by the investigator.

The choice of chemotherapy may include medications such as paclitaxel, paclitaxel albumin-bound, or capecitabine.

3 medication administration

Trastuzumab deruxtecan is administered through an intravenous infusion. The frequency and dosage are determined by the study protocol.

If assigned to chemotherapy, paclitaxel or paclitaxel albumin-bound is given intravenously, while capecitabine is taken orally.

4 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

Assessments include imaging tests and laboratory evaluations to track disease progression and response to treatment.

5 study duration

The study is expected to continue until June 2026, with individual participation lasting as long as the treatment is effective and tolerated.

Participants are followed up regularly to evaluate overall survival and progression-free survival.

Who Can Join the Study?

  • Patients must be at least 18 years old.
  • Must have breast cancer that is advanced or has spread to other parts of the body (metastatic).
  • The cancer must have a history of being HER2-low or negative. HER2 is a protein that can affect the growth of cancer cells. HER2-low means the cancer has low levels of this protein.
  • The cancer must have hormone receptor positive (HR+) disease, meaning the cancer grows in response to hormones.
  • Must have enough tumor samples to check the HER2 status.
  • The disease must have gotten worse after at least two previous treatments with hormone therapy, with or without other targeted treatments. If the disease got worse within 24 months of hormone therapy after surgery, it counts as one treatment.
  • The disease must have gotten worse on hormone therapy plus a CDK4/6 inhibitor within 6 months of starting the first treatment for metastatic disease. A CDK4/6 inhibitor is a type of drug that helps stop cancer cells from growing.
  • Must not have had chemotherapy for advanced or metastatic breast cancer before.
  • Must have adequate organ and bone marrow function as defined by the study protocol. This means the organs and bone marrow are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not shown progression of their cancer after receiving hormone therapy.
  • Patients who have a different level of HER2 protein than the one specified in the study.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend required visits.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Da Luz S.A. Lisbon Portugal
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Centre Francois Baclesse Caen France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Institut Sainte Catherine Avignon France
Azienda Ospedaliera Papardo Messina Italy
Cfnnuoeif Usjvmwhkrdtpop Sgyqjurxf Woluwe-Saint-Lambert Belgium
Shjgwplkwkdmfxq At Stockholm Sweden
Ibgqihxw Pzdzolxuacbswym Ciunck Cihyfh Marseille France
Hemhvjhy Vcfo dvuekitv Barcelona Spain
Bspnbcjow Ucojyk Uvtko Kimnso Budapest Hungary
Hbdvazsa Ubsaxrtfxiimk da A Ctonod A Coruna Galicia Spain
Vajfge dob Rjfvp Ujqxufkano Htmujvgj Sevilla Spain
Oapncu Ueaynrnjtp Hvugdwvz Odense Denmark
Uyqinpa Uzanjhxjme Hpyhzczj Uppsala Sweden
Hcrpjtdw Cslkfi Dp Bmhxmrdsw Barcelona Spain
Cfekerj Uxynkbjhwtfyktkxgpbt Bxzcnu Kes Berlin Germany
Euzllfk Upgfhztltpuq Mqirqmj Cmowpig Roclywlcp (thhqduy Mkd Rotterdam The Netherlands
Ctnprf Hueeguqtsmn Rtncekgi Ujwnwfuehhtzk De Tlgbj Tours France
Iasbn Oiitsrdm Pxnmwmijisv Srf Movbchs Genoa Italy
Ubinvvedzvkirzaktxtiz Mjbwlhfx Alq Munster Germany
Amtcvej Uivxhuqgwb Hirkcpur Aalborg Denmark
Afmoijm Ojmddofgjmj Uyatzdaavjurw Fxzvnoua Io Dq Niqdfr Naples Italy
Kdzknwgq dzw Uflusuxxyzth Mottwuwd Afa Munich Germany
Rutonikhsojdqt Copenhagen Denmark
Kutiwnrx def Twsiykrozeo Uiokvumtlres Mteluftz (nqj Ksxhgcniv Munich Germany
Aewzgta Onbmzzfobnx Pdib Goesxzwe Xaclr Bergamo Italy
Craquw hkgviidxjyc uqkzgzkxhjozm dp Lnjzw Liege Belgium
Uwucwsrcbbjm Zqxmiqlnoa Gxnc Gent Belgium
Avuuykw Scnnsfdoe Umsisvddfcokj Fevkko Crjclxew Udine Italy
Cnaalf Hdwbhxrvzbd Lajm Shq Pierre Benite France
Hmjeznrz Uzwsdznpcuuqx Dj La Pikrdpah Madrid Spain
Inhcanks Cuwlzg Dmfakyhlysqzeobvw L'hospitalet De Llobregat Spain
Ucqvwiqyahsormsfq Dfnku Sxvgc Dg Fiwfpze Ferrara Italy
Atdfcpur Zobreecobc Dhxhm Roeselare Belgium
Fpfqhkgwc Pgtq Lg Ityxliohjnekm Bflykynge Dzu Hixtnoqm Uoumjnkmajxhr Lg Pdn Madrid Spain
Cuemkm Hktkguzkkfc Udhabkhpizxhn Dsafcn Ghyrrjq Sumtkmrdlatarbuqhberhxjzkx Namur Belgium
Vlmid Sint-Niklaas Belgium
Fsfeptjdad Iayekjhxjg Iprcwssc Njhyewwycbw Bytya Milan Italy
Iengwilh Oukuqcqzkg Vgbtbl Padua Italy
Icyupxfb Rteyqmuv Dz Crxptv Dr Mrxcfwonhbx Montpellier France
Okicndzp Ohkxjsidgi Inbmply Budapest Hungary
Bndiydyxtrn Vfmduniic Oaxjizocttfc Kecskemet Hungary
Ppu Frlkduutsp Dt Cwklg E Reexsfiii Cjms G Pcetiw Tricase Italy
Cxlwonkd Vobfcp Hmev Le Mans France
Ajqfpog Ucu Testpfk nptx ovigi Leghorn Italy
Cxcyva Dq Lnumg Cieyip Lf Cotzis Epgeft Mulvxqu Rennes France
Iuugtjfg Dr Ciovhguz Fbitrowlji Dpd Pvdvmvzg Pdb Lpauistmuz Ikuut Candiolo Italy
Bjkbhegy Uvkyizdqsq Haxlfqdk Chdyne Besançon France
Sueokaliajwhdtgiktsadr Vfglqoebi Oqbdbubasfdg Nyiregyhaza Hungary
Gqvaxhkdddpfuqnoq Vvtsxnkvj Pkae Amevvr Erikhczx Optpvp Kytzcl Gyor Hungary
Hdxxaulz Uqapbxfgqrjoi Dstrokxk Donostia / San Sebastian Spain
Atcujut Uad Tsktrov Cumflg Prato Italy
Ndgwmlyk Idhbtckj Ooexanyep Idx Mfoog Svpdyfwmkeaqjjqjnoboymixmnxm Iesvzxlo Bjcubdth Cracow Poland
Auxadfs Okteoisspkq Udprvhhdhianu Pkcaz Parma Italy
Gstuq Hgpyoec Da Cpjjaogxb Charleroi Belgium
Drztgzntebrl Ccyqxsv Oncfyisez Pnuhfhitwumt I Howwacxzkra Wroclaw Poland
Jrcrsscwkomqilwmgmnh Vowkduihu Htyajpo Gped Kmmjvdobikjxgfbzcsbll Szolnok Hungary
Huknyhtu Cfr Difojmxfmlq Smyn Lisbon Portugal
Zilrukqhycnedsy Takvhl Safhiuymh Almelo The Netherlands
Mgixnqodirocy Vcvlzds Grm Velbert Germany

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
02.08.2024
Belgium Belgium
Not recruiting
02.08.2024
Denmark Denmark
Not recruiting
02.08.2024
France France
Not recruiting
02.08.2024
Germany Germany
Not recruiting
02.08.2024
Hungary Hungary
Not recruiting
02.08.2024
Italy Italy
Not recruiting
02.08.2024
Poland Poland
Not recruiting
02.08.2024
Portugal Portugal
Not recruiting
02.08.2024
Spain Spain
Not recruiting
02.08.2024
Sweden Sweden
Not recruiting
02.08.2024
The Netherlands The Netherlands
Not recruiting
02.08.2024

Trial locations

Trastuzumab Deruxtecan (T-DXd) is a medication used in this clinical trial to treat breast cancer. It is specifically designed for patients with HER2-low, hormone receptor-positive breast cancer that has progressed despite previous endocrine therapy. This medication works by targeting and delivering chemotherapy directly to cancer cells, which may help to slow down or stop the growth of the cancer.

Investigator’s Choice Chemotherapy refers to a selection of standard chemotherapy treatments chosen by the doctors involved in the trial. These treatments are used as a comparison to evaluate the effectiveness of Trastuzumab Deruxtecan. The specific chemotherapy drugs used can vary, but they are commonly used options for treating breast cancer that has not responded to other treatments.

HER2-Low, Hormone Receptor Positive Breast Cancer – This type of breast cancer is characterized by low levels of the HER2 protein and the presence of hormone receptors. It typically occurs when cancer cells have a HER2 protein expression that is lower than what is considered HER2-positive but higher than HER2-negative. The cancer progresses as it grows and spreads to other parts of the body, often after initial treatment with hormone therapy. This progression can lead to the cancer becoming more aggressive and resistant to standard treatments. The disease is often monitored for changes in tumor size and spread to assess its progression. Understanding the specific characteristics of this cancer type is crucial for determining the most effective treatment approach.

Trial ID:
2024-516653-44-00
Protocol code:
D9670C00001
NCT ID:
NCT04494425
Trial Phase:
Therapeutic confirmatory (Phase III)

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