PET in Breast Cancer Receiving Neoadjuvant Chemotherapy (DA-PET)
|ClinicalTrials.gov Identifier: NCT01396655|
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||June 2011|
Experimental: docetaxel + doxorubicin
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.
Drug: docetaxel (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.
- pathologic complete response [ Time Frame: 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.
- survival (Relapse-free survival, overall survival) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396655
|Principal Investigator:||Bhumsuk Keam, MD||Seoul National University Hospital|
|Principal Investigator:||Seock-Ah Im, MD PhD||Seoul National University Hospital|