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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


Phase 2
20 Years
70 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response

Outcome Description:

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.

Outcome Time Frame:

after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)

Safety Issue:

No

Principal Investigator

Bhumsuk Keam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Seoul National University Hospital:Korea

Study ID:

DA-PET-2010-0022299

NCT ID:

NCT01396655

Start Date:

July 2006

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • breast cancer
  • neoadjuvant chemotherapy
  • molecular marker
  • FDG PET
  • locally advanced breast cancer
  • Breast Neoplasms

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