Study on GDC-4198 Alone and with Giredestrant Compared to Abemaciclib and Giredestrant for Advanced ER+ HER2- Breast Cancer
Sponsor: Genentech, Inc.
ClinicalTrials ID:NCT07100106
This clinical trial is testing the safety and effectiveness of a new drug, GDC-4198, alone and in combination with giredestrant, compared to the combination of abemaciclib and giredestrant in patients with advanced estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate how safe GDC-4198 is when used alone and with giredestrant, and to compare its effectiveness with the combination of abemaciclib and giredestrant in patients with advanced or metastatic ER+ HER2- breast cancer. The trial has two parts: Phase Ib will focus on the safety and how the body processes GDC-4198, both alone and with giredestrant. Phase II will compare how well the combination of GDC-4198 and giredestrant works against the combination of abemaciclib and giredestrant.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic breast cancer that is ER+ and HER2-.
- Cancer must have progressed during or after treatment with a CDK4/6 inhibitor and hormone therapy for advanced or metastatic cancer.
- Have cancer that can be measured or evaluated according to specific medical criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 6 months.
Exclusion Criteria
- Have advanced cancer that has spread to vital organs and is at risk of causing life-threatening complications soon, requiring immediate chemotherapy.
- Have received more than one previous treatment for advanced or metastatic cancer.
- Have had chemotherapy for metastatic breast cancer.
- Have taken any anti-cancer treatments, including experimental ones, within a certain period before starting the study drug.
- Have poor vein access for blood draws or infusions.
- Have digestive issues that could affect how the body absorbs the study drug.
- Have had another cancer within the last 3 years, except for the breast cancer being studied or cancers with a very low risk of spreading or causing death.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| City of Hope - Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| City of Hope® Cancer Center Chicago | 60099 | Zion | Illinois |
| New York Cancer & Blood Specialists | 11772 | East Patchogue | New York |
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