Phase 2 N=123 Treatment

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00193206 ↗

Enrolled (actual)

123

Serious AEs

17.9%

Results posted

Nov 2012

Primary outcome: Primary: Pathologic Complete Response — 23 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gemcitabine (Drug); Epirubicin (Drug); Albumin-bound Paclitaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: SCRI Development Innovations, LLC
Primary completion: Oct 2008

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.