Clinical trial · Interventional
Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study
NCT00308178CI-TRIAL-00009488completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support
- timeFrame
- 2 years
- measure
- to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane
- timeFrame
- 2 years
- measure
- to evaluate quality of life.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer, with clinical stage I, II, or III disease * Must register at the beginning of adjuvant or neoadjuvant chemotherapy * 18 years of age or older * ECOG performance status of 0 or 1 * Normal organ and marrow function Exclusion Criteria: * Previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason * Pregnant or nursing * Receiving any other investigational agents * Patients with Stage IV breast cancer * Current grade II or greater peripheral neuropathy or prior history of grade II or greater neuropathy * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Immune deficiency when treated with marrow-suppressive therapy or HIV-positive patients receiving anti-retroviral therapy * Patients with sickle cell disease * Known history of hyperviscosity syndrome * Patients on lithium
References
Publications (0)
Data not yet available
No reference posted for this study.