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PET in Breast Cancer Receiving Neoadjuvant Chemotherapy (DA-PET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396655
First Posted: July 19, 2011
Last Update Posted: July 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
June 16, 2011
July 19, 2011
July 19, 2011
July 2006
September 2008   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
PET in Breast Cancer Receiving Neoadjuvant Chemotherapy
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

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
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.
Experimental: docetaxel + doxorubicin
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.
Intervention: Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
June 2011
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01396655
DA-PET-2010-0022299
Not Provided
Not Provided
Not Provided
Seock-Ah Im, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Bhumsuk Keam, MD Seoul National University Hospital
Principal Investigator: Seock-Ah Im, MD PhD Seoul National University Hospital
Seoul National University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP