NCT01526499

Brief Summary

The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic 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
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2 breast-cancer

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

January 29, 2012

Last Update Submit

February 5, 2012

Conditions

Breast Cancer

Keywords

Metronomic cyclophosphamidemetastatic breast cancerfirst linedocetaxel

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    6 weeks

Secondary Outcomes (6)

  • Biomarker serum VEGF level

    6 weeks

  • Biomarker immuno-marker

    6 weeks

  • Efficacy Overall Response Rate

    6 weeks

  • Efficacy Overall Survival

    6 weeks

  • Safety

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

TC

EXPERIMENTAL

Docetaxel plus Cyclophosphamide

Drug: Docetaxel and Cyclophosphamide (TC)

T

ACTIVE COMPARATOR

Docetaxel

Drug: Docetaxel (T)

Interventions

Docetaxel and Cyclophosphamide (TC)DRUG

Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days

TC
Docetaxel (T)DRUG

Docetaxel 75mg/m2 IVGTT D1;every 21days

T

Eligibility Criteria

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

You may qualify if:

  • Females with age between 18 and 70 years old
  • ECOG performance between 0-1
  • Life expectancy more than 3 months
  • Histological proven unresectable recurrent or advanced breast cancer
  • No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).
  • At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
  • No anticancer therapy within 4 weeks
  • Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
  • Provision of written informed consent prior to any study specific procedures

You may not qualify if:

  • Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
  • Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
  • Treatment with an investigational product within 4 weeks before the first treatment
  • Symptomatic central nervous system metastases
  • Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
  • Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
  • Uncontrolled serious infection
  • Patients with bad compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Zhonghua Wang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leiping Wang, MD

CONTACT

+862164175590leipingwang@163.com

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
principal investigator

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 6, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

CN(1)