Breast Cancer
Conditions
Keywords
Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar
Brief 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.
Detailed description
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.
Interventions
DRUGGemcitabine
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
DRUGEpirubicin
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
DRUGAlbumin-bound Paclitaxel
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Sponsors
Eli Lilly and Company
Celgene Corporation
SCRI Development Innovations, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Rates of Breast Preservation | 18 months | Number of patients who underwent breast conservation after neo adjuvant chemotherapy |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 123 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Postoperative Therapy | Intercurrent Illness | 2 |
| Postoperative Therapy | Lack of Efficacy | 1 |
| Postoperative Therapy | Physician Decision | 3 |
| Postoperative Therapy | Protocol Violation | 1 |
| Postoperative Therapy | Withdrawal by Subject | 7 |
| Preoperative Therapy | Adverse Event | 2 |
| Preoperative Therapy | False Positive Pregnancy Test | 1 |
| Preoperative Therapy | Lack of Efficacy | 2 |
| Preoperative Therapy | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 51 years |
| Region of Enrollment United States | 123 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 123 |
| serious Total, serious adverse events | 22 / 123 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Pathologic Complete Response | 23 Participants |
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)
Time frame: 18 months
Population: All patients who received neoadjuvant chemotherapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Clinical Response Rates | 109 Participants |
Secondary
Rates of Breast Preservation
Number of patients who underwent breast conservation after neo adjuvant chemotherapy
Time frame: 18 months
Population: patients who had completed all 6 prescribed doses of neoadjuvant chemotherapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Rates of Breast Preservation | 26 Participants |
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)
Time frame: 36 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Time to Disease Progression | 13.7 months |