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NCT06188559 · ClinicalTrials.gov registry record · Phase 2
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Eisai.
- Active
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT06188559: Active Phase 2 study of Breast Cancer, sponsored by Eisai.
NCT06188559 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Eisai. The registered enrollment target is 135 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06188559, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2). The primary purpose of Dose Expansion (Part 2) is to assess the antitumor activity of BB-1701 at RD in the selected population(s) of breast cancer (BC).
Primary Outcome
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; Any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (example, electrocardiogram \[ECG\] or x-ray) that results in symptoms, a change in treatme
Conditions Studied
Interventions
- DRUG BB-1701
Study Locations (20)
California
- Cancer and Blood Specialty Clinic - Los Alamitos
- UCLA Center for East-West Medicine - Los Angeles
- UCSF - San Francisco
New Jersey
- Astera Cancer Care - East Brunswick
- Summit Medical Group - Florham Park
- Rutgers Cancer Institute of New Jersey - New Brunswick
Florida
- AdventHealth Cancer Institute - Orlando - Orlando
- Moffitt Cancer Center - Tampa
Indiana
- Fort Wayne Medical Oncology & Hematology - Fort Wayne
- Community Cancer Center South - Indianapolis
Nebraska
- NHO Revive Research Institute LLC - Lincoln
- Nebraska Cancer Specialist - Omaha
Ohio
- Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center) - Cleveland
- Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center - Cleveland
Connecticut
- Yale New Haven Hospital - New Haven
Iowa
- Mission Blood and Cancer - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What the registry record for NCT06188559 still lists
NCT06188559 is an interventional study that assigns participants to a tested intervention. The registered 135 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 1 intervention - of which BB-1701 is the first listed.
NCT06188559 names 20 study sites across 12 states, led by California, New Jersey, Florida.
Frequently Asked Questions
What is clinical trial NCT06188559 about?
NCT06188559 is a clinical study titled "A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer". The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2). The primary purpose of Dose Expansion (Part 2) is to assess the antitumor activity of BB-1701 at ...
What is the current status of trial NCT06188559?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2024-04-10. Estimated completion is 2027-03-31.
What conditions does trial NCT06188559 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06188559?
The interventions under investigation include: BB-1701 (DRUG).
Who is sponsoring clinical trial NCT06188559?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06188559 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Indiana, Iowa. 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 NCT06188559's enrollment target sits among peer trials
135 474th of 1224 higher than 747 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.
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