NCT01352494

Brief Summary

The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

May 9, 2011

Last Update Submit

May 25, 2011

Conditions

Breast Cancer Stage IIBreast Cancer Stage III

Keywords

locally advanced breast cancerdocetaxelgemcitabine

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate was assessed by pathologic examination after surgery.

    2 years

Secondary Outcomes (4)

  • Type of surgery (Breast Conserving Rate)

    6 month

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    1 year

  • progression free survival

    2 years

  • quality of life

    2 years

Study Arms (1)

docetaxel/gemcitabine

EXPERIMENTAL

All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)

Drug: docetaxelDrug: gemcitabine

Interventions

docetaxelDRUG

docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles

Also known as: Doxotel®
docetaxel/gemcitabine
gemcitabineDRUG

gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles

Also known as: Gemcibine®
docetaxel/gemcitabine

Eligibility Criteria

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

You may qualify if:

  • Women aged : 20\~70 years
  • World Health Organization (WHO) (Eastern Cooperative Oncology Group \[ECOG\]) performance status 0-2
  • Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
  • Have given written informed consent and are available for prolonged follow-up

You may not qualify if:

  • Patients with previous chemotherapy for recurrent breast cancer
  • Breast cancer recurrence within 12 months after taxane treatment
  • Her-2/neu expression breast cancer
  • Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
  • Brain metastasis
  • uncontrolled infection, medically uncontrollable heart disease
  • other serious medical illness or prior malignancies
  • Pregnant or lactating women were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, the Catholic university of Korea, St. Vincent's hospital

Suwon, Gyeonggi-do, South Korea

Location

Related Publications (1)

  • Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19.

    PMID: 29285038DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Young Jin Suh, M.D. Ph.D

    Department of Surgery, the Catholic university of Korea, St. Vincent's hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ku Sang Kim, M.D.

CONTACT

82-31-219-5200ideakims@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 12, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2015

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

KR(1)