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NCT02315196 · ClinicalTrials.gov registry record · Phase 2
Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer
A Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT02315196: Active Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, sponsored by Rutgers, The State University of New Jersey.
NCT02315196 is a Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 62 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315196, a Phase 2 study of Triple Negative Breast Cancer and HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative). Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel may be an effective treatment for breast cancer.
Primary Outcome
The pCR rate will first be determined as proportions and calculating its 95% confidence interval. To study the association between pCR response (yes/no) and the presence of gross residual disease, type and number of mutations, clinical lymph node status (positive/negative), tumor size (\< 2 cm/\>= 2 cm) based on p53, logistic regression analysis will be used, controlling for cancer treatment and disease stage and other covariates if numbers allow.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- PROCEDURE therapeutic conventional surgery
- DRUG pegylated liposomal doxorubicin hydrochloride
- DRUG epirubicin hydrochloride
Study Locations (1)
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2041-07 |
| Phase | Phase 2 |
What the registry record for NCT02315196 still lists
NCT02315196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (75% lower).
The record links to 9 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT02315196 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT02315196 about?
NCT02315196 is a clinical study titled "Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer". This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth fa...
What is the current status of trial NCT02315196?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2015-02-25. Estimated completion is 2041-07.
What conditions does trial NCT02315196 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, HER2-Negative Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.
What interventions are being tested in trial NCT02315196?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), therapeutic conventional surgery (PROCEDURE), pegylated liposomal doxorubicin hydrochloride (DRUG), epirubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02315196?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02315196 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative 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 NCT02315196's enrollment target sits among peer trials
62 68th of 118 higher than 51 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative 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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