Trial comparing treatments for Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT07100106
What this study is testing
What is GDC-4198?
GDC-4198 is an investigational oral medicine being studied for the treatment of breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe the new drug GDC‑4198 is alone and with giredestrant, and compares it to the standard treatment abemaciclib plus giredestrant.
- Who it's for
- Women or men with locally advanced or metastatic estrogen‑receptor positive, HER2‑negative breast cancer.
- What's involved
- Participants may receive GDC‑4198 alone or with giredestrant, or the standard abemaciclib plus giredestrant, and will have regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The study has two parts: a safety phase followed by a comparison phase, lasting several months with scheduled clinic visits and tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and approved endocrine therapy (ET) in...
- 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.
You likely can't join if
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic...
- 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
- Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral...
- History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk...
See the full eligibility 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...
- 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.
- Current participant enrolled in Study RGT-419B\_01-101 who is experiencing clinical benefit from GDC-4198, as determined by the investigator, at the time of consent and enrollment in this study.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Zion, Illinois, United States
- Detroit, Maine, United States
- Annapolis, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- East Patchogue, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Tucson, Arizona, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; San Diego, California, United States and 62 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.