Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07214662 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Genentech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
- 3
- Study locations
NCT07214662: Recruiting Phase 1 study of Breast Cancer, sponsored by Genentech.
NCT07214662 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Genentech. The registered enrollment target is 136 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07214662, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Genentech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.
Primary Outcome
Measured by reporting the incidence and severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale.
Conditions Studied
Interventions
- DRUG Omeprazole
- DRUG Giredestrant
- DRUG GDC-0587
Study Locations (3)
Michigan
- START - Midwest - EDOS - Grand Rapids
Texas
- START - San Antonio - EDOS - San Antonio
Other
- National Cheng Kung University Hospital - Tainan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2026-01-13 |
| Est. Completion | 2030-04-01 |
| Phase | Phase 1 |
What NCT07214662 shows while recruiting
NCT07214662 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Omeprazole is the first listed.
NCT07214662 reports a single indexed study location in Michigan, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT07214662 about?
NCT07214662 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer". This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrog...
What is the current status of trial NCT07214662?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2026-01-13. Estimated completion is 2030-04-01.
What conditions does trial NCT07214662 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT07214662?
The interventions under investigation include: Omeprazole (DRUG), Giredestrant (DRUG), GDC-0587 (DRUG).
Who is sponsoring clinical trial NCT07214662?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07214662 being conducted?
This trial has 3 study locations across Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07214662's enrollment target sits among peer trials
136 473rd of 1224 higher than 752 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01555892 · 136 participants · Phase 1
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
- NCT03216525 · 136 participants · Phase 3
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
- NCT04476901 · 136 participants · Phase 2
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
- NCT04603898 · 136 participants · NA
Oxalate Formation From Ascorbic Acid
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI