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

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. Identifier: NCT01396655
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 19, 2011
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396655

Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Bhumsuk Keam, MD Seoul National University Hospital
Principal Investigator: Seock-Ah Im, MD PhD Seoul National University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Seock-Ah Im, Seoul National University Hospital Identifier: NCT01396655    
Other Study ID Numbers: DA-PET-2010-0022299
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011
Keywords provided by Seoul National University Hospital:
breast cancer
neoadjuvant chemotherapy
molecular marker
locally advanced breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors