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Back|NCT07100106Recruiting
Official Title

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
Phase 1/Phase 2
Sponsor
Genentech, Inc.
Enrollment
285
Timeline
Oct 2025 → Jul 2030
About This Study

The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.

Eligibility Criteria

Inclusion Criteria

  • 1Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.
  • 2Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines.
  • 3Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine therapy (ET) in the locally advanced or metastatic setting.
  • 4Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • 5Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • 6Life expectancy ≥ 6 months

Exclusion Criteria

  • 1Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.
  • 2Have received more than one-line of therapy for locally advanced or metastatic disease.
  • 3Have received prior chemotherapy for metastatic breast cancer
  • 4Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half -lives, whichever is shorter, prior to initiation of study drug. Treatment with an approved oral endocrine therapy (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.
  • 5Poor peripheral venous access
  • 6Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
  • 7History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.

Locations

9 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322-1013

Recruiting

City of Hope

Duarte, California 91010

Recruiting

City of Hope - Orange County Lennar Foundation Cancer Center

Irvine, California 92618

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →