Phase 2
Completed N=123
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Source: ClinicalTrials.gov NCT00193206 ↗Enrolled (actual)
123
Serious AEs
17.9%
Results posted
Nov 2012
Primary outcomePrimary: Pathologic Complete Response — 23 Participants
Summary
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response |
23 | — |
| SECONDARY Clinical Response Rates |
109 | — |
| SECONDARY Time to Disease Progression |
13.7 | — |
| SECONDARY Rates of Breast Preservation |
26 | — |
Eligibility Criteria
Inclusion Criteria
To be included in this study, you must meet the following criteria:
- Locally advanced/inflammatory adenocarcinoma of the breast
- 18 years of age or older
- Normal heart function
- Able to perform activities of daily living with minimal assistance
- No prior chemotherapy for breast cancer
- Adequate bone marrow, liver and kidney function
- No evidence or history of significant cardiovascular abnormalities
- Sentinel node or axillary dissection
- Sign an informed consent form
Exclusion Criteria
You cannot participate in this study if any of the following apply to you:
- Pregnant or breast feeding
- History of heart disease with congestive heart failure
- Heart attack within the previous 6 months
- Prior chemotherapy or hormone therapy for breast cancer
- History of active uncontrolled infection
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Data sourced from ClinicalTrials.gov (NCT00193206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.