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A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer

ConditionAdvanced or Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

The study will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-4198 when given in combination with endocrine therapy (ET) (letrozole, fulvestrant, or giredestrant) as first-line treatment to participants with locally advanced or metastatic Hormone receptor (HR)-positive, Human epidermal growth factor receptor-2 (HER2)-negative breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and HER2-negative disease.

Disease documented HER2-negative tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines or documented ER-positive tumor according to ASCO/CAP guidelines.

Measurable and/or non-measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (including bone-only disease).

For females <= 60 years of age who are not in a postmenopausal state and males: initiation of treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy prior to initiation of study treatment according to clinical practice for the selected agent (preferably at least 14 days prior to initiation of study treatment), and agreement to continue LHRH agonist therapy for the duration of the study. LHRH agonist therapy may be discontinued in women > 60 years of age.

Disqualifiers

Advanced, symptomatic, visceral spread at the time of study entry that is at risk of life-threating complications and for which treatment with cytotoxic chemotherapy is considered appropriate per local treatment guidelines.

Symptomatic, untreated, or actively progressing CNS metastases.

History of systemic anti-cancer therapy for unresectable locally advanced breast cancer or metastatic breast cancer.

Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GDC-4198

    Drug

    Participants will receive GDC-4198 as per the schedule described in the protocol.

  • Fulvestrant

    Drug

    Participants will receive fulvestrant as per the schedule described in the protocol.

  • Letrozole

    Drug

    Participants will receive letrozole as per the schedule described in the protocol.

  • Giredestrant

    Drug

    Participants will receive giredestrant as per the schedule described in the protocol.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: GDC-4198 with fulvestrantExperimental treatment 2 interventions
Group B: GDC-4198 with letrozoleExperimental treatment 2 interventions
Group C: GDC-4198 with giredestrantExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and Severity of Adverse Events (AEs)

Time frame
Approximately 30 months

Secondary outcomes

1

Plasma Concentration of GDC-4198

Time frame
Approximately 30 months
2

Objective Response Rate (ORR)

Time frame
Approximately 30 months
3

Clinical Benefit Rate (CBR)

Time frame
Approximately 30 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: