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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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GDC-4198

    Drug

    GDC-4198 will be administered orally.

  • Giredestrant

    Drug

    Giredestrant will be administered orally.

  • Abemaciclib

    Drug

    Abemaciclib will be administered orally.

Treatment groups

285 Participants
are divided into 4 treatment groups
Group A: Phase Ib: Dose-Finding StageExperimental treatment 2 interventions
Group B: Phase II: Arm AExperimental treatment 2 interventions
Group C: Phase II: Arm BExperimental treatment 2 interventions
Group D: Phase II: Arm CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase Ib: Incidence and Severity of Adverse Events (AEs)

Severity of AEs determined according to the CTCAE v5.0 grading scale

Time frame
Up to 36 months
2

Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs)

Time frame
From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
3

Phase II: Progression-free Survival (PFS)

Time frame
Up to 36 months

Secondary outcomes

1

Phase Ib: Objective Response Rate (ORR)

Time frame
Up to 36 months
2

Phase Ib: Clinical Benefit Rate (CBR)

Time frame
Up to 36 months
3

Phase II: ORR

Time frame
Up to 36 months
4

Phase II: Duration of Response (DOR)

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Roche (China) Holding Ltd.

Collaborator

Source ClinicalTrials.gov
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