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NCT01853748 · ClinicalTrials.gov registry record · Phase 2
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 512
- Enrollment target
NCT01853748 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 512 participants.
The verdict
NCT01853748, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 512 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Trastuzumab emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2013-05 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01853748
The ClinicalTrials.gov registry entry for NCT01853748 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01853748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01853748 about?
NCT01853748 is a clinical study titled "T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)". This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out mo...
What is the current status of trial NCT01853748?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 512 participants. The study started on 2013-05. Estimated completion is 2022-06-15.
What interventions are being tested in trial NCT01853748?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Trastuzumab emtansine (DRUG).
Who is sponsoring clinical trial NCT01853748?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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