Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

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About the trial

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Kobiety w wieku od 18 do 75 lat.
  • •Zdiagnozowany rak piersi z przerzutami, który jest dodatni pod względem hormonów (estrogenu i/lub progesteronu) i ujemny pod względem HER2.
  • •Rak jest miejscowo zaawansowany (nie można go całkowicie usunąć miejscowo) lub powrócił w formie przerzutów.
  • •Choroba jest mierzalna w badaniach obrazowych lub obecne są zmiany w kościach, nawet jeśli nie są mierzalne.
  • •Organizm dobrze reaguje na leczenie (prawidłowe wyniki badań krwi dotyczące białych krwinek, płytek krwi i hemoglobiny).
  • •Pacjentka wcześniej nie otrzymywała chemioterapii ani leczenia celowanego z powodu przerzutów.
  • •Dobre ogólne samopoczucie (wskazane przez punktację ECOG ≤ 2) i przewidywana długość życia co najmniej 3 miesiące.
  • •Pacjentka świadomie zgadza się na udział w badaniu i przestrzega jego zasad.

✗ Disqualifies

  • •Leczenie chemioterapią, radioterapią, immunoterapią lub zabiegi chirurgiczne z powodu choroby z przerzutami w ostatnim czasie (z wyjątkiem drobnych zabiegów ambulatoryjnych).
  • •Aktywne lub objawowe przerzuty do mózgu, które wymagają leczenia.
  • •Poważne problemy z sercem (np. niewydolność serca, zawał serca w ciągu ostatnich 6 miesięcy).
  • •Ciąża lub karmienie piersią.
  • •Inne nowotwory zdiagnozowane w ciągu ostatnich pięciu lat (z wyjątkiem wyleczonego raka skóry podstawno-komórkowego).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
February 8, 2024
Sex
Female only

Therapies / drugs in trial

Locations (1)

Fudan University Shanghai cancer center

Shanghai, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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