PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically-confirmed breast cancer by core needle biopsy, initial clinical stage II or III, objective measurable lesion, ECOG performance 0 2, previously untreated, adequate bone marrow, hepatic, cardiac, and renal functions age 20 70 agreement with this trial, and written informed consent Exclusion Criteria: history of other cancer active infection pregnancy psychologic disease uncontrolled heart diseases male

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel + doxorubicin<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response | 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. | after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival (Relapse-free survival, overall survival) | Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods | 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy | 
| early metabolic response | 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 | before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle) | 
| predictive factors | Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis | after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy) | 
| hematologic toxicity | 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. | every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant chemotherapy, molecular marker, FDG PET, locally advanced breast cancer