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NCT06001762 · ClinicalTrials.gov registry record · Phase 2
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
A Phase 2 study of Breast Cancer and Early Stage Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 12
- Study locations
NCT06001762: Active Phase 2 study of Breast Cancer and Early Stage Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT06001762 is a Phase 2 study of Breast Cancer and Early Stage Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 12 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06001762, a Phase 2 study of Breast Cancer and Early Stage Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 12
- Study locations
Study Summary
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Primary Outcome
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 3 months (12 weeks).
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Abemaciclib
Study Locations (12)
Massachusetts
- Boston Medical Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- Dana-Farber Cancer Institute at Steward St. Elizabeth's - Brighton
- Dana-Farber Cancer Institute at Foxborough - Foxborough
- Dana-Farber Cancer Institute at Merrimack Valley - Methuen
- Dana-Farber Cancer Institute at Milford - Milford
- Dana-Farber Cancer Institute at South Shore - South Weymouth
Maine
- Eastern Maine Medical Center (Northern Light) - Brewer
- New England Cancer Specialists - Scarborough
Connecticut
- Stamford Hospital - Stamford
New Hampshire
- Dana-Farber Cancer Insitute at Londonderry Hospital - Londonderry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
What the registry record for NCT06001762 still lists
NCT06001762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tamoxifen is the first listed.
NCT06001762 lists 12 locations in 4 states (Massachusetts, Maine, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06001762 about?
NCT06001762 is a clinical study titled "TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer". In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study dru...
What is the current status of trial NCT06001762?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2023-10-05. Estimated completion is 2027-01-01.
What conditions does trial NCT06001762 study?
This clinical trial studies the following conditions: Breast Cancer, Early Stage Breast Cancer, High Risk Breast Carcinoma.
What interventions are being tested in trial NCT06001762?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT06001762?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06001762 being conducted?
This trial has 12 study locations across Connecticut, Maine, Massachusetts, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06001762's enrollment target sits among peer trials
90 613th of 1224 higher than 604 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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