NCT02041351

Brief Summary

There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

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

November 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 18, 2014

Last Update Submit

January 26, 2016

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancertaxanesheavily pretreated

Outcome Measures

Primary Outcomes (1)

  • disease free interval

    more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed

    4 months

Secondary Outcomes (2)

  • partial response

    2 months

  • rate response

    3 months

Study Arms (1)

docetaxel

EXPERIMENTAL

measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.

Drug: Docetaxel

Interventions

DocetaxelDRUG

evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy

Also known as: evaluating the response rate and progression-free interval
docetaxel

Eligibility Criteria

Age21 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Male patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and over 85 years of age. Metastasis of one site in the central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Universitario Contra El Cáncer

Monterrey, Nuevo León, 64460, Mexico

Location

Jesus Livio Jimenez Santos

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jesús L Santos, doctor

    Centro Universitario contra el Cáncer U.A.N.L.

    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
medical oncology resident

Study Record Dates

First Submitted

January 18, 2014

First Posted

January 22, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

ME(2)