Trial · NCT00193206

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

NCT00193206, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2012-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer. Trials, record NCT00193206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00193206

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
NCT number: NCT00193206
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: SCRI Development Innovations, LLC
Conditions: Breast Cancer
Interventions: Gemcitabine, Epirubicin, Albumin-bound Paclitaxel
First posted: 2005-09-19
Last updated: 2021-11-23
Results first posted: 2012-11-30

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response	18 months	For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Secondary	Clinical Response Rates	18 months	Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size \>50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary	Time to Disease Progression	36 months	Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of \>25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary	Rates of Breast Preservation	18 months	Number of patients who underwent breast conservation after neo adjuvant chemotherapy

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response	18 months	7 patients did not complete the study. Only the patients who had surgical procedures following neoadjuvant chemotherapy were included in the analysis as pathologic complete response is assessing the gross or microscopic response in the tissue sample resected at the time of surgery.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Response Rates	18 months	All patients who received neoadjuvant chemotherapy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Disease Progression	36 months		months	MEDIAN
SECONDARY	Rates of Breast Preservation	18 months	patients who had completed all 6 prescribed doses of neoadjuvant chemotherapy	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pathologic Complete Response	Intervention	23		Participants
Clinical Response Rates	Intervention	109		Participants
Time to Disease Progression	Intervention	13.7	Full Range 1.5 to 29.8	months
Rates of Breast Preservation	Intervention	26		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Preoperative Therapy	STARTED	Intervention	123
Preoperative Therapy	COMPLETED	Intervention	116
Preoperative Therapy	NOT COMPLETED	Intervention	7
Surgery	STARTED	Intervention	116
Surgery	COMPLETED	Intervention	116
Surgery	NOT COMPLETED	Intervention	0
Postoperative Therapy	STARTED	Intervention	116
Postoperative Therapy	COMPLETED	Intervention	102
Postoperative Therapy	NOT COMPLETED	Intervention	14

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neutrophils	Blood and lymphatic system disorders	Intervention	13	123
other	Platelets	Blood and lymphatic system disorders	Intervention	7	123
other	Arthralgia/Myalgia	Musculoskeletal and connective tissue disorders	Intervention	8	123
other	Fatigue	General disorders	Intervention	7	123
other	Thrombosis/Thrombus/Embolism	Vascular disorders	Intervention	6	123
serious	Cardiac Ischemia/Infarction	Cardiac disorders	Intervention	1	123	1
serious	Infection - Skin	Infections and infestations	Intervention	3	123	3
serious	Pain - Chest	Cardiac disorders	Intervention	2	123	2
serious	Infection - Gastrointestinal	Infections and infestations	Intervention	1	123	1
serious	Dehydration	Gastrointestinal disorders	Intervention	2	123	2

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention
Total, other adverse events	Intervention	41	123
Total, serious adverse events	Intervention	22	123

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20670921	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00193206

GET https://conductscience.org/api/trials/v1/NCT00193206/registered

API reference For AI assistants