Breast Cancer
Conditions
Brief summary
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.
Detailed description
Upon determination of eligibility, all patients will be receive: Gemcitabine + Epirubicin + Docetaxel
Interventions
DRUGGemcitabine
Gemcitabine
DRUGEpirubicin
Epirubicin
DRUGDocetaxel
Docetaxel
Sponsors
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
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: * Adenocarcinoma of the breast confirmed by biopsy * Female Patients \>18 years of age * Normal cardiac function * Ability to perform activities of daily living with minimal assistance * Chemotherapy naïve or have received prior chemotherapy \> 5 years ago * Adequate bone marrow, liver and kidney function * Be informed of the investigational nature of this study * Sign an informed consent form * Sentinel lymph node and/or axillary dissection prior to enrollment
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Life expectancy of \< than 6 months * History of significant heart disease * Prior chemotherapy or hormonal therapy * Concurrent Trastuzumab therapy * History of significant psychiatric disorders * History of active uncontrolled infection Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response (pCR) | 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). 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 |
|---|---|---|
| Time to Treatment Failure (TTF) | 69 months | Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: * disease progression date (RECIST or clinical) * death date * treatment discontinuation |
| Overall Survival (OS) | 48 months | Number of participants that are alive at 48th months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Adjuvant | Intercurrent Hospitalization | 3 |
| Adjuvant | Lack of Efficacy | 2 |
| Adjuvant | Physician Decision | 5 |
| Neoadjuvant Treatment | Adverse Event | 2 |
| Neoadjuvant Treatment | Intercurrent Illness | 3 |
| Neoadjuvant Treatment | Lack of Efficacy | 2 |
| Neoadjuvant Treatment | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 51 years |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 38 / 110 |
| other Total, other adverse events | 71 / 110 |
| serious Total, serious adverse events | 17 / 110 |
Outcome results
Primary
Pathologic Complete Response (pCR)
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Pathologic Complete Response (pCR) | 18 percentage of participants |
Secondary
Overall Survival (OS)
Number of participants that are alive at 48th months
Time frame: 48 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Overall Survival (OS) | 72 Participants |
Secondary
Time to Treatment Failure (TTF)
Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: * disease progression date (RECIST or clinical) * death date * treatment discontinuation
Time frame: 69 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Time to Treatment Failure (TTF) | 13 months |