NCT02137083

Brief Summary

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

May 6, 2014

Last Update Submit

January 21, 2018

Conditions

Metastatic Breast Cancer

Keywords

ChemotherapyEndocrine therapyDocetaxelFulvestrant

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    6 weeks

Secondary Outcomes (2)

  • Overall Response Rate

    6 Weeks

  • Overall Survival

    6 Weeks

Study Arms (2)

Docetaxel Plus Fulvestrant

EXPERIMENTAL

Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later

Drug: DocetaxelDrug: Fulvestrant

Docetaxel

ACTIVE COMPARATOR

Docetaxel:75mg/m2 D2 every 21 days

Drug: Docetaxel

Interventions

DocetaxelDRUG

75mg/m2 D2 every 21 days

Also known as: Taxotere
DocetaxelDocetaxel Plus Fulvestrant
FulvestrantDRUG

500mg D1, D15, D29, D57, every 28 days later

Also known as: Faslodex
Docetaxel Plus Fulvestrant

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal female between 18 and 70 years old
  • ECOG performance status of ≤ 1
  • Life expectancy more than 3 months
  • Histologically confirmed metastatic breast cancer
  • ER and\&or PR pqositive, HER2-negative
  • Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
  • No pretreated chemotherapy for metastatic disease
  • Have at least one target lesion according to RECIST 1.1
  • No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
  • Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>50ml/min

You may not qualify if:

  • Pregnant or lactating women
  • Evidence of CNS metastasis
  • Seriously uncontrolled infection
  • History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pretreated with Fulvestrant
  • Pretreated with two or more lines of endocrine therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelFulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Xichun Hu, MD, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of department of medical oncology

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 13, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CN(1)