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NCT01750073 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer
A Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by University of Nebraska.
- Active
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 4
- Study locations
NCT01750073: Active Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, sponsored by University of Nebraska.
NCT01750073 is a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 92 participants, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (81% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750073, a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may block tumor growth in different ways by targeting certain cells. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Number of participants in each subset (Her2 positive and Her2 negative) who experience at least one adverse event \[overall incidence of toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\].
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- RADIATION Radiation Therapy
- DRUG Doxorubicin Hydrochloride
Study Locations (4)
Nebraska
- Nebraska Medicine-Bellevue - Bellevue
- CHI Health Saint Francis - Grand Island
- Nebraska Medicine-Village Pointe Cancer Center - Omaha
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2012-12-07 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT01750073 still lists
NCT01750073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01750073 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT01750073 about?
NCT01750073 is a clinical study titled "Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer". This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways ...
What is the current status of trial NCT01750073?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2012-12-07. Estimated completion is 2026-06.
What conditions does trial NCT01750073 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer, HER2/Neu Negative, Estrogen Receptor Negative, Progesterone Receptor Negative.
What interventions are being tested in trial NCT01750073?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Radiation Therapy (RADIATION), Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01750073?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01750073 being conducted?
This trial has 4 study locations across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
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 NCT01750073's enrollment target sits among peer trials
92 28th of 45 higher than 18 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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