Trial Outcomes & Findings for Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer (NCT NCT00193206)

NCT ID: NCT00193206

Last Updated: 2021-11-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 123 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2021-11-23

Participant Flow

Participant milestones

Measure	Intervention Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Preoperative Therapy STARTED	123
Preoperative Therapy COMPLETED	116
Preoperative Therapy NOT COMPLETED	7
Surgery STARTED	116
Surgery COMPLETED	116
Surgery NOT COMPLETED	0
Postoperative Therapy STARTED	116
Postoperative Therapy COMPLETED	102
Postoperative Therapy NOT COMPLETED	14

Reasons for withdrawal

Measure	Intervention Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Preoperative Therapy Lack of Efficacy	2
Preoperative Therapy Adverse Event	2
Preoperative Therapy Withdrawal by Subject	2
Preoperative Therapy False Positive Pregnancy Test	1
Postoperative Therapy Withdrawal by Subject	7
Postoperative Therapy Physician Decision	3
Postoperative Therapy Intercurrent Illness	2
Postoperative Therapy Lack of Efficacy	1
Postoperative Therapy Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention n=123 Participants Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: 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.

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.

Outcome measures

Measure	Intervention n=116 Participants Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Pathologic Complete Response	23 Participants

SECONDARY outcome

Timeframe: 18 months

Population: All patients who received neoadjuvant chemotherapy

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)

Outcome measures

Measure	Intervention n=123 Participants Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Clinical Response Rates	109 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intervention n=123 Participants Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Time to Disease Progression	13.7 months Interval 1.5 to 29.8

SECONDARY outcome

Timeframe: 18 months

Population: patients who had completed all 6 prescribed doses of neoadjuvant chemotherapy

Number of patients who underwent breast conservation after neo adjuvant chemotherapy

Outcome measures

Measure	Intervention n=116 Participants Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Rates of Breast Preservation	26 Participants

Adverse Events

Intervention

Serious events: 22 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=123 participants at risk Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Cardiac disorders Cardiac Ischemia/Infarction	0.81% 1/123 • Number of events 1
Infections and infestations Infection - Skin	2.4% 3/123 • Number of events 4
Cardiac disorders Pain - Chest	1.6% 2/123 • Number of events 2
Infections and infestations Infection - Gastrointestinal	0.81% 1/123 • Number of events 1
Gastrointestinal disorders Dehydration	1.6% 2/123 • Number of events 2
Vascular disorders Thrombosis/Thrombus/Embolism	1.6% 2/123 • Number of events 2
Infections and infestations Infection - Vein	1.6% 2/123 • Number of events 2
General disorders Death	0.81% 1/123 • Number of events 1
Musculoskeletal and connective tissue disorders Fracture	1.6% 2/123 • Number of events 2
Hepatobiliary disorders Pain - Liver	0.81% 1/123 • Number of events 1
Infections and infestations Infection - Pneumonia	0.81% 1/123 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.81% 1/123 • Number of events 1
Psychiatric disorders Neurology - Other	0.81% 1/123 • Number of events 1
General disorders Weakness	0.81% 1/123 • Number of events 1

Other adverse events

Measure	Intervention n=123 participants at risk Systemic Therapy ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Blood and lymphatic system disorders Neutrophils	10.6% 13/123
Blood and lymphatic system disorders Platelets	5.7% 7/123
Musculoskeletal and connective tissue disorders Arthralgia/Myalgia	6.5% 8/123
General disorders Fatigue	5.7% 7/123
Vascular disorders Thrombosis/Thrombus/Embolism	4.9% 6/123

Additional Information

John D. Hainsworth, MD

Sarah Cannon Research Institute

Phone: 877-691-7274

Email: ASKSARAH@scresearch.net

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
• Publication restrictions are in place

Restriction type: OTHER