Breast Cancer
Conditions
Keywords
Triple negative (ER/PR negative; HER2 negative)
Brief summary
This neoadjuvant chemotherapy protocol focusing on triple-negative breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.
Detailed description
Women with a diagnosed triple-negative proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.
Interventions
DRUGDoxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin
DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks
PROCEDUREDefinitive Surgery
Standard of care definitive surgery as determined by medical provider
RADIATIONRadiotherapy
Standard of care RADIATION THERAPY as indicated
Sponsors
Leo W. Jenkins Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable) * Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.) * Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.) * Absolute neutrophil count \> 1500 mm3 and platelet count \> 100,000 mm3 * Normal myocardial left ventricular function * Serum creatinine \< 2.0 mg/dl * Total bilirubin and AST \< 3X upper limits normal
Exclusion criteria
* Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol) * Another active cancer present * Medical contraindications to chemotherapy or surgery * First trimester pregnancy * Breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1) Pathologic Response | Upon completion therapy after surgery | Pathologic measurement post-surgery viable primary tumor mass |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study; Taxol, XRT, Gemzar and Carbo Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks
Definitive Surgery: Standard of care definitive surgery as determined by medical provider
Radiotherapy: Standard of care RADIATION THERAPY as indicated | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | Single Arm Study; Taxol, XRT, Gemzar and Carbo |
|---|---|
| Age, Continuous | 50 years |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 3 / 21 |
Outcome results
Primary
1) Pathologic Response
Pathologic measurement post-surgery viable primary tumor mass
Time frame: Upon completion therapy after surgery
Population: Study closed to accrual - not enough participants to participate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm Study; Taxol, XRT, Gemzar and Carbo | 1) Pathologic Response | 15 Participants |