Breast Cancer
Conditions
Keywords
breast cancer, neoadjuvant chemotherapy, molecular marker, FDG PET, locally advanced breast cancer
Brief summary
Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer. The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.
Interventions
DRUGdocetaxel (75 mg/m2) and doxorubicin (50 mg/m2)
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. pathologically-confirmed breast cancer by core needle biopsy, 2. initial clinical stage II or III, 3. objective measurable lesion, 4. ECOG performance 0\ 2, 5. previously untreated, 6. adequate bone marrow, hepatic, cardiac, and renal functions 7. age 20\ 70 8. agreement with this trial, and written informed consent
Exclusion criteria
1. history of other cancer 2. active infection 3. pregnancy 4. psychologic disease 5. uncontrolled heart diseases 6. male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic complete response | after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy) | The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival (Relapse-free survival, overall survival) | 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy | Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods |
| early metabolic response | before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle) | Early metabolic response were evaluated by serial FDG PET/CT before and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle). Declining of SUV were calculated |
| predictive factors | after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy) | Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis |
| hematologic toxicity | every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy) | Hematologic toxicities are evaluated every q 3weeks during chemotherapy. Neutropenia,thrombocytopenia, and anemia are evaluated during chemotherapy (per cycles) by NCI CTCAE v3.0 criteria. |
Outcome results
None listed