HER2-low Unresectable and/or Metastatic Breast Cancer in Russia

Last updated: March 17, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05913440
D133HR00029
  • Ages > 18
  • All Genders

Study Summary

Planned study population consists of approximately 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with confirmed HER2 low status (IHC1+ or IHC2+/ISH ).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with confirmed diagnosis of unresectable and/or metastatic BC establishedbetween the 1st July 2021 and the 1st July 2022.

  • Patients have HER2-negative status (IHC0, IHC1+, IHC2+/ISH-) obtained in the locallaboratory.

-. Patients have an adequate archival tumor sample and slides suitable forreassessment HER2 status* by the reference laboratory.

  • Patients have documented hormonal status (ER, PR) IHC score.

  • Age ≥ 18 years at the time of inclusion.

  • Patients provided written consent allowing for data and samples to be used in thefuture and this study would be covered by the consent for future use in accordancewith ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior toinclusion in the study. If the patient is deceased, a waiver may be accepted

Exclusion

Exclusion Criteria:

  • Patients with previous HER2 positive status in the anamnesis at the diagnosis orafter the diagnosis of breast cancer.

  • Presence of other malignancies within period since diagnosis until the timepoint ofdata collection.

  • Patients receiving trastuzumab deruxtecan currently or received in anamnesis.

  • The participation in any randomised controlled trial within period since diagnosisuntil end of study.

Study Design

Total Participants: 1500
Study Start date:
May 30, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Research Site

    Arkhangelsk,
    Russian Federation

    Site Not Available

  • Research Site

    Balashikha,
    Russian Federation

    Site Not Available

  • Research Site

    Barnaul,
    Russian Federation

    Site Not Available

  • Research Site

    Belgorod,
    Russian Federation

    Site Not Available

  • Research Site

    Cheliabinsk,
    Russian Federation

    Site Not Available

  • Research Site

    Chelyabinsk,
    Russian Federation

    Site Not Available

  • Research Site

    Chita,
    Russian Federation

    Site Not Available

  • Research Site

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Research Site

    Grozny,
    Russian Federation

    Site Not Available

  • Research Site

    Irkutsk,
    Russian Federation

    Site Not Available

  • Research Site

    Istra,
    Russian Federation

    Site Not Available

  • Research Site

    Izhevsk,
    Russian Federation

    Site Not Available

  • Research Site

    Kaluga,
    Russian Federation

    Site Not Available

  • Research Site

    Kazan,
    Russian Federation

    Site Not Available

  • Research Site

    Kemerovo,
    Russian Federation

    Site Not Available

  • Research Site

    Khabarovsk,
    Russian Federation

    Site Not Available

  • Research Site

    Khanty-Mansiysk,
    Russian Federation

    Site Not Available

  • Research Site

    Khimki,
    Russian Federation

    Site Not Available

  • Research Site

    Kirov,
    Russian Federation

    Site Not Available

  • Research Site

    Klin,
    Russian Federation

    Site Not Available

  • Research Site

    Kolomna,
    Russian Federation

    Site Not Available

  • Research Site

    Korolev,
    Russian Federation

    Site Not Available

  • Research Site

    Kostroma,
    Russian Federation

    Site Not Available

  • Research Site

    Krasnodar,
    Russian Federation

    Site Not Available

  • Research Site

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • Research Site

    Maikop,
    Russian Federation

    Site Not Available

  • Research Site

    Makhachkala,
    Russian Federation

    Site Not Available

  • Research Site

    Maykop,
    Russian Federation

    Site Not Available

  • Research Site

    Moscow,
    Russian Federation

    Site Not Available

  • Research Site

    Nalchik,
    Russian Federation

    Site Not Available

  • Research Site

    Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Research Site

    Novokuznetsk,
    Russian Federation

    Site Not Available

  • Research Site

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Research Site

    Noyabrsk,
    Russian Federation

    Site Not Available

  • Research Site

    Omsk,
    Russian Federation

    Site Not Available

  • Research Site

    Orenburg,
    Russian Federation

    Site Not Available

  • Research Site

    Perm,
    Russian Federation

    Site Not Available

  • Research Site

    Plievo,
    Russian Federation

    Site Not Available

  • Research Site

    Podolsk,
    Russian Federation

    Site Not Available

  • Research Site

    Pyatigorsk,
    Russian Federation

    Site Not Available

  • Research Site

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Research Site

    Ryazan,
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Peterburg,
    Russian Federation

    Site Not Available

  • Research Site

    Samara,
    Russian Federation

    Site Not Available

  • Research Site

    Saransk,
    Russian Federation

    Site Not Available

  • Research Site

    Saratov,
    Russian Federation

    Site Not Available

  • Research Site

    Sevedorvinsk,
    Russian Federation

    Site Not Available

  • Research Site

    Severodvinsk,
    Russian Federation

    Site Not Available

  • Research Site

    Smolensk,
    Russian Federation

    Site Not Available

  • Research Site

    Sochi,
    Russian Federation

    Site Not Available

  • Research Site

    Surgut,
    Russian Federation

    Site Not Available

  • Research Site

    Syktyvkar,
    Russian Federation

    Site Not Available

  • Research Site

    Tomsk,
    Russian Federation

    Site Not Available

  • Research Site

    Tver,
    Russian Federation

    Site Not Available

  • Research Site

    Ufa,
    Russian Federation

    Site Not Available

  • Research Site

    Ulan-Ude,
    Russian Federation

    Site Not Available

  • Research Site

    Ulianovsk,
    Russian Federation

    Site Not Available

  • Research Site

    Ulyanovsk,
    Russian Federation

    Site Not Available

  • Research Site

    Vladivostok,
    Russian Federation

    Site Not Available

  • Research Site

    Volgograd,
    Russian Federation

    Site Not Available

  • Research Site

    Voronezh,
    Russian Federation

    Site Not Available

  • Research Site

    Yaroslavl,
    Russian Federation

    Site Not Available

  • Research Site

    Yekaterinburg,
    Russian Federation

    Site Not Available

  • Research Site

    Yuzhno-Sakhalinsk,
    Russian Federation

    Site Not Available

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