PET in Breast Cancer Receiving Neoadjuvant Chemotherapy
NCT ID: NCT01396655
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2006-07-31
2011-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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docetaxel + doxorubicin
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. active infection
3. pregnancy
4. psychologic disease
5. uncontrolled heart diseases
6. male
20 Years
70 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seock-Ah Im
Professor
Principal Investigators
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Bhumsuk Keam, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Seock-Ah Im, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
References
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Keam B, Im SA, Koh Y, Han SW, Oh DY, Cho N, Kim JH, Han W, Kang KW, Moon WK, Kim TY, Park IA, Noh DY, Chung JK, Bang YJ. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer. 2011 Oct 20;11:452. doi: 10.1186/1471-2407-11-452.
Other Identifiers
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DA-PET-2010-0022299
Identifier Type: -
Identifier Source: org_study_id
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