To compare the Safety and activity of GDC-4198 Alone and in Combination with Giredestrant against Abemaciclib and Giredestrant in Participants with Breast Cancer
Key facts
- Where
- Dresden, Erlangen, Essen, Hamburg, Hanover, Heidelberg és Tuebingen, NémetországSee the 7 sites
- Phase
- 1/2. fázis
Where in Németország
- Technische Universitaet DresdenDresden, NémetországTaking people
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Medizinische Hochschule HannoverHanover, NémetországTaking people
- National Center for Tumor Diseases (NCT) HeidelbergHeidelberg, NémetországTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech Inc.
- Trial code
- EU 2025-521128-31-00
- Record updated
- 2026. október 12.
- Original description
Phase Ib Stage: To evaluate the safety of GDC-4198 alone and in combination with giredestrant Phase II Stage: To compare the efficacy of two dose levels of GDC-4198 in combination with giredestrant to the efficacy of abemaciclib in combination with giredestrantRead full original descriptionShow less
A Phase Ib/ II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer who Have Previously Progressed During or After a CDK4/6 Inhibitor
Phase Ib Stage: To evaluate the safety of GDC-4198 alone and in combination with giredestrant Phase II Stage: To compare the efficacy of two dose levels of GDC-4198 in combination with giredestrant to the efficacy of abemaciclib in combination with giredestrant
Inclusion: Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced (not amenable to surgical or radiation therapy with curative intent) or metastatic; Previously documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP; Allison et al. 2020) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines; Previously documented HER2– tumor according to ASCO/CAP (Wolff et al. 2023) or ESMO guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines; Disease progression during or after treatment with an approved CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, ribociclib, etc.) and approved endocrine therapy (ET) in the locally advanced or metastatic setting; Measurable or non-measurable evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion: Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions [pleural, pericardial, peritoneal] or pulmonary lymphangitis) appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines; Have received more than one-line of therapy for locally advanced or metastatic disease; Have received prior chemotherapy for metastatic breast cancer; Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug.