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A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer

NCT07100106

RecruitingPhase 1, Phase 2

Sponsor: Genentech, Inc.

Conditions: Breast Cancer

Interventions: GDC-4198, Giredestrant, Abemaciclib

Countries: United States, Australia, Brazil, Canada, China, France, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.
* Previously 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.
* Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor 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 version 1.1 (RECIST v1.1).
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Life expectancy \>= 6 months.

Exclusion Criteria:

* Advanced, 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.
* 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.
* Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
* History 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.
* Known allergy or hypersensitivity to any component of the study treatments.

Locations (52)

Duarte, California, United States
Irvine, California, United States
La Jolla, California, United States
San Francisco, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Zion, Illinois, United States
Detroit, Maine, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
East Patchogue, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Darlinghurst, New South Wales, Australia
Adelaide, South Australia, Australia
Recife, Pernambuco, Brazil
Ijuí, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, Brazil
Toronto, Ontario, Canada
Jinan, SD, China
Shanghai, Shanghai Municipality, China
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