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NCT01937117 · ClinicalTrials.gov registry record · Phase 2
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 10
- Study locations
NCT01937117: Active Phase 2 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01937117 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 88 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01937117, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 10
- Study locations
Study Summary
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
Primary Outcome
SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- PROCEDURE Positron emission tomography (PET)
Study Locations (10)
Texas
- Baylor College of Medicine - Houston
- The University of Texas MD Anderson Cancer Center - Houston
Alabama
- University of Alabama Comprehensive Cancer Center - Birmingham
District of Columbia
- Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital - Washington D.C.
Indiana
- Indiana University Simon Cancer Center - Indianapolis
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Minnesota
- Mayo Clinic - Rochester
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2014-01-30 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT01937117 still lists
NCT01937117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 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 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01937117 lists 10 locations in 9 states (Texas, Alabama, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT01937117 about?
NCT01937117 is a clinical study titled "Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer". This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
What is the current status of trial NCT01937117?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2014-01-30. Estimated completion is 2026-06.
What conditions does trial NCT01937117 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01937117?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), Positron emission tomography (PET) (PROCEDURE).
Who is sponsoring clinical trial NCT01937117?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01937117 being conducted?
This trial has 10 study locations across Alabama, District of Columbia, Indiana, Maryland, Minnesota. 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 NCT01937117's enrollment target sits among peer trials
88 625th of 1224 higher than 598 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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