NCT00721747

Brief Summary

The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.

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
83

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

6 active sites

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

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

July 23, 2008

Last Update Submit

March 15, 2012

Conditions

Breast Cancer

Keywords

breast cancer patients her2 negative pathological responses

Outcome Measures

Primary Outcomes (1)

  • Determine proportion of Pathological complete responses

    At the end of the treatment, after Surgery.

Secondary Outcomes (6)

  • Determine proportion of clinical responses

    At the end of the treatment

  • Describe treatment safety

    At the end of the treatment

  • Determine proportion of conservative breast surgery

    At the end of the study

  • Evaluate disease free survival

    At the end of the treatment

  • Evaluate Overall survival

    At the end of the treatment

  • +1 more secondary outcomes

Study Arms (1)

Unique arm

EXPERIMENTAL

4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv

Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide

Interventions

Docetaxel, Liposomal doxorubicine and CyclophosphamideDRUG

4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv

Unique arm

Eligibility Criteria

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

You may qualify if:

  • Brest adenocarcinoma stages II/III
  • Female
  • Informed consent signed
  • HER2 negative
  • Age\>18 years old
  • ECOG \< 1
  • Proper organic function regarding the following criteria:
  • ANC \> 2,0 x 109L, platelets \> 100 x 109L and hemoglobin \> 10g/dL (transfusion is allowed)
  • Hepatic Function:
  • i.Bilirubin \< 1,5 x UNL ii.AST ,ALT \< 2,5 x UNL iii.Alkaline phosphatase \< 5 UNL iv.Patients with AST and /or ALT \> 1.5 x UNL and alkaline phosphatase \> 2.5 x UNL will not be selected for the study c.Renal function: creatinine \< 1,25 x UNL, or creatinine clearance \> 60 mL/min d.Normal Cardiac function, confirmed with FEVI \>50% and electrocardiogram.
  • Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site
  • Negative pregnancy test(performed 7 days before treatment)

You may not qualify if:

  • Previous treatment for breast cancer (CT, RT, IT, HT)
  • Stages IIIb, IIIc or IV or invasive bilateral breast cancer
  • Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel)
  • Pregnant or breastfeeding females
  • Neurotoxicity Grade 2
  • FEV≤50% or any cardiac disease in which anthracyclines are contraindicated
  • Other severe diseases regarding investigator criteria
  • Any neurological or psychiatric pathology
  • Previous neoplasia different from breast cancer except:
  • skin cancer(no melanoma)
  • In situ cervix Carcinoma
  • Ipsilateral in situ ductal carcinoma
  • In situ lobular in situ carcinoma
  • Any other carcinoma without evidence disease in last 10 years
  • Concomitant treatment with Hormone ovarian replacement therapy
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital de Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Hospital Juan Canalejo

A Coruña, Galicia, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, Galicia, 15009, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Galicia, 32005, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Xeral Cies

Vigo, Galicia, 36204, Spain

Location

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

  • Jesús García Mata, MD

    Grupo Oncológico Gallego

    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
SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 24, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2015

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

ES(6)