NCT01396655

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2006

Typical duration for phase_2 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
Last Updated

April 17, 2025

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

June 16, 2011

Last Update Submit

April 14, 2025

Conditions

Breast Cancer

Keywords

breast cancerneoadjuvant chemotherapymolecular markerFDG PETlocally advanced breast cancer

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response

    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.

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

Secondary Outcomes (4)

  • survival (Relapse-free survival, overall survival)

    2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy

  • early metabolic response

    before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)

  • predictive factors

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

  • hematologic toxicity

    every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)

Study Arms (1)

docetaxel + doxorubicin

EXPERIMENTAL

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)

Interventions

docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)DRUG

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.

docetaxel + doxorubicin

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologically-confirmed breast cancer by core needle biopsy,
  • initial clinical stage II or III,
  • objective measurable lesion,
  • ECOG performance 0\~2,
  • previously untreated,
  • adequate bone marrow, hepatic, cardiac, and renal functions
  • age 20\~70
  • agreement with this trial, and written informed consent

You may not qualify if:

  • history of other cancer
  • active infection
  • pregnancy
  • psychologic disease
  • uncontrolled heart diseases
  • male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22011459DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Bhumsuk Keam, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Seock-Ah Im, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2011

First Posted

July 19, 2011

Study Start

July 1, 2006

Primary Completion

September 1, 2008

Study Completion

June 1, 2011

Last Updated

April 17, 2025

Record last verified: 2011-07