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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| Celgene Corporation | INDUSTRY |
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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.
Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:
Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim
Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim
Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rates | 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) |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Denise A. Yardley, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States | ||
| Integrated Community Oncology Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20670921 | Background | Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Preoperative Therapy |
|
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| Epirubicin | Drug | Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles |
|
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| Albumin-bound Paclitaxel | Drug | ABI-007 175 mg/m2 D1 q 14 days x 6 cycles |
|
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| 18 months |
| Time to Disease Progression | 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) | 36 months |
| Rates of Breast Preservation | Number of patients who underwent breast conservation after neo adjuvant chemotherapy | 18 months |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Watson Clinic Center for Cancer Care and Research | Lakeland | Florida | 33805 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Consultants in Blood Disorders and Cancer | Louisville | Kentucky | 40207 | United States |
| Hematology Oncology Life Center | Alexandria | Louisiana | 71301 | United States |
| Mercy Hospital | Portland | Maine | 04101 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Chattanooga Oncology and Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Surgery |
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| Postoperative Therapy |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response | 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. | 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. | Posted | Count of Participants | Participants | 18 months |
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| ||||||||||||||||||||||||||
| Secondary | Clinical Response Rates | 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) | All patients who received neoadjuvant chemotherapy | Posted | Count of Participants | Participants | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | 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) | Posted | Median | Full Range | months | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Rates of Breast Preservation | Number of patients who underwent breast conservation after neo adjuvant chemotherapy | patients who had completed all 6 prescribed doses of neoadjuvant chemotherapy | Posted | Count of Participants | Participants | 18 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 22 | 123 | 41 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Ischemia/Infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Angina |
|
| Infection - Skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Cellulitis |
|
| Pain - Chest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Gastrointestinal | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Colitis |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Vein | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Septic Thrombophlebitis |
|
| Death | General disorders | CTCAE (3.0) | Systematic Assessment | Intercurrent Illness |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Liver | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Port Site Infection |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | Progressive Disease |
|
| Neurology - Other | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | Suicidal Ideations |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Neutropenia |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Thrombocytopenia |
|
| Arthralgia/Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Hainsworth, MD | Sarah Cannon Research Institute | 877-691-7274 | ASKSARAH@scresearch.net |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D015251 | Epirubicin |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Lack of Efficacy |
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| Protocol Violation |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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