GDC-4198 Alone and With Giredestrant for Breast Cancer

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

Recruiting Phase 1 Phase 2 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
285 (estimated)
Sponsor
Genentech, Inc. · Industry
Who this trial is looking for

This trial is looking for people with advanced breast cancer that is hormone receptor positive and HER2 negative. Participants will receive GDC-4198 by itself or with another drug, Giredestrant, to see how well it works and compare it to another treatment option.

Are You a Good Fit for This Trial?
Must not be taking FulvestrantCDK4/6 inhibitors

You may be able to join if

  • I have been diagnosed with breast cancer that is locally advanced or metastatic.
  • My cancer has estrogen receptors and does not have HER2.
  • My cancer has gotten worse after treatment with certain cancer therapies.
  • I have measurable or assessable disease.
  • I have a good performance status with an ECOG score of 0 or 1.
  • My life expectancy is at least 6 months.

You may not be able to join if

  • I have advanced cancer that could cause life-threatening complications.
  • I have had more than one line of therapy for advanced cancer.
  • I have received chemotherapy for metastatic breast cancer.
  • I took certain cancer medications within the last few weeks.
  • I have a condition that may interfere with how my body absorbs medications.
  • I have had another type of cancer in the last 3 years, except for this breast cancer.
  • I am allergic to any parts of the study treatments.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 a…
Trial Locations
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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 …
Contacts

Reference Study ID Number: GO46021 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT