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NCT04893109 · ClinicalTrials.gov registry record · Phase 2
ATEMPT 2.0: Adjuvant T-DM1 vs TH
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT04893109: Recruiting Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04893109 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 500 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04893109, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel
Primary Outcome
Compare the incidence of clinically relevant toxicities (CRT) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine followed by trastuzumab SC to the incidence in those treated with paclitaxel in combination with trastuzumab SC as assessed by PRO-CTCAE
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG trastuzumab-emtansine
- DRUG Trastuzumab SC
Study Locations (20)
Connecticut
- Smilow Cancer Hospital Care center at Derby - Derby
- Smilow Cancer Hospital Care center at Fairfield - Fairfield
- Smilow Cancer Hospital Care center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care center at Greenwich - Greenwich
- Smilow Cancer Hospital Care center at Guilford - Guilford
- Smilow Cancer Hospital Care center at St. Francis - Hartford
- Smilow Cancer Hospital Care center at Long Ridge - Long Ridge
- Yale Cancer Center at Yale University School of Medicine - New Haven
- Smilow Cancer Hospital Care center at North Haven - North Haven
- Stamford Hospital - Stamford
- Smilow Cancer Hospital Care center at Torrington - Torrington
- Smilow Cancer Hospital Care center at Trumbull - Trumbull
- Smilow Cancer Hospital Care center at Waterbury - Waterbury
- Smilow Cancer Hospital Care center at Waterford - Waterford
Florida
- Miami Cancer Institute/Baptist Hospital of Miami - Miami
- Miami Cancer Institute - Plantation (MCIP) - Plantation
Indiana
- Indiana University Health Joe & Shelly Schwarz Cancer Center - Carmel
- IU Health North Hospital - Carmel
California
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Illinois
- The University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-06-16 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 2 |
What NCT04893109 shows while recruiting
NCT04893109 is an interventional study that assigns participants to a tested intervention. The registered 500 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 (82% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT04893109 names 20 study sites across 5 states, led by Connecticut, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT04893109 about?
NCT04893109 is a clinical study titled "ATEMPT 2.0: Adjuvant T-DM1 vs TH". This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM...
What is the current status of trial NCT04893109?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2021-06-16. Estimated completion is 2028-05-01.
What conditions does trial NCT04893109 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer.
What interventions are being tested in trial NCT04893109?
The interventions under investigation include: Paclitaxel (DRUG), trastuzumab-emtansine (DRUG), Trastuzumab SC (DRUG).
Who is sponsoring clinical trial NCT04893109?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04893109 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. 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 NCT04893109's enrollment target sits among peer trials
500 193rd of 1224 higher than 1,022 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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