A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

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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 is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjentki zgadzają się stosować odpowiednie metody antykoncepcji.
  • Kobiety w wieku rozrodczym i mężczyźni przyjmujący terapię LHRH (hormonalna) co najmniej 2 tygodnie przed rozpoczęciem badania i przez cały jego czas.
  • Rak piersi (z przerzutami lub zaawansowany miejscowo), potwierdzony badaniem histopatologicznym.
  • Nowotwór potwierdzony jako ER+ (receptory estrogenowe dodatnie) i HER2- (receptor ludzkiego naskórkowego czynnika wzrostu 2 ujemny).
  • Rak piersi z przerzutami lub zaawansowany miejscowo, który nie zareagował lub przestał reagować na poprzednie leczenie inhibitorem CDK 4/6.
  • Widoczne lub możliwe do oceny zmiany w badaniach obrazowych.
  • Ogólny stan zdrowia pozwalający na aktywność (grupa 0-1 w skali ECOG).
  • Przewidywana długość życia co najmniej 6 miesięcy.

✗ Disqualifies

  • Kobiety w ciąży lub karmiące piersią, lub planujące zajść w ciążę podczas badania.
  • Zagrażające życiu przerzuty, które wymagają natychmiastowego leczenia chemioterapią.
  • Przyjęcie pięciu lub więcej wcześniejszych linii leczenia systemowego w przypadku raka piersi z przerzutami lub zaawansowanego miejscowo.
  • Przyjmowanie innych terapii przeciwnowotworowych (w tym badań klinicznych) w ciągu ostatnich 28 dni przed rozpoczęciem leczenia w badaniu.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 21, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

START - Midwest - EDOS

Grand Rapids, United States

START - San Antonio - EDOS

San Antonio, United States

National Taiwan University Hospital

Taipei, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Share this trial

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

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