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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01396655
First received: June 16, 2011
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pathologic complete response [ Time Frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy) ] [ Designated as safety issue: No ]
    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:
  • survival (Relapse-free survival, overall survival) [ Time Frame: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 78
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396655

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

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seock-Ah Im, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01396655     History of Changes
Other Study ID Numbers: DA-PET-2010-0022299
Study First Received: June 16, 2011
Last Updated: July 15, 2011
Health Authority: Seoul National University Hospital:Korea

Keywords provided by Seoul National University Hospital:
breast cancer
neoadjuvant chemotherapy
molecular marker
FDG PET
locally advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
 Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013