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Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Sponsored by
Grupo Oncológico Gallego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer patients her2 negative pathological responses

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Brest adenocarcinoma stages II/III
  • Female
  • Informed consent signed
  • HER2 negative
  • Age>18 years old
  • ECOG < 1

  • Proper organic function regarding the following criteria:

    1. ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed)
    2. 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)

Exclusion Criteria:

  • 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:

    1. skin cancer(no melanoma)
    2. In situ cervix Carcinoma
    3. Ipsilateral in situ ductal carcinoma
    4. In situ lobular in situ carcinoma
    5. Any other carcinoma without evidence disease in last 10 years
  • Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (* 20 mg methylprednisolone or equivalent)
  • Concomitant treatment with Hormone ovarian replacement therapy
  • Contraindication for corticoids
  • Concomitant treatment with another investigational drugs
  • Included in another clinical trial with any drug in 30 days before inclusion study
  • Concomitant treatment with another anticancer therapy
  • Male patients
  • Hypersensibility to any study drug or components

Sites / Locations

  • Hospital de Hospitalet
  • Hospital Juan Canalejo
  • Centro Oncológico de Galicia
  • Complejo Hospitalario de Ourense
  • Hospital Clínico Universitario de Santiago
  • Hospital Xeral Cies

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unique arm

Arm Description

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

Outcomes

Primary Outcome Measures

Determine proportion of Pathological complete responses

Secondary Outcome Measures

Determine proportion of clinical responses
Describe treatment safety
Determine proportion of conservative breast surgery
Evaluate disease free survival
Evaluate Overall survival
Evaluate gene patterns regarding prediction of treatment response

Full Information

First Posted
July 23, 2008
Last Updated
March 15, 2012
Sponsor
Grupo Oncológico Gallego
Collaborators
Pivotal S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT00721747
Brief Title
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer
Official Title
Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Oncológico Gallego
Collaborators
Pivotal S.L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer patients her2 negative pathological responses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unique arm
Arm Type
Experimental
Arm Description
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Intervention Description
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
Primary Outcome Measure Information:
Title
Determine proportion of Pathological complete responses
Time Frame
At the end of the treatment, after Surgery.
Secondary Outcome Measure Information:
Title
Determine proportion of clinical responses
Time Frame
At the end of the treatment
Title
Describe treatment safety
Time Frame
At the end of the treatment
Title
Determine proportion of conservative breast surgery
Time Frame
At the end of the study
Title
Evaluate disease free survival
Time Frame
At the end of the treatment
Title
Evaluate Overall survival
Time Frame
At the end of the treatment
Title
Evaluate gene patterns regarding prediction of treatment response
Time Frame
At the end of the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (* 20 mg methylprednisolone or equivalent) Concomitant treatment with Hormone ovarian replacement therapy Contraindication for corticoids Concomitant treatment with another investigational drugs Included in another clinical trial with any drug in 30 days before inclusion study Concomitant treatment with another anticancer therapy Male patients Hypersensibility to any study drug or components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús García Mata, MD
Organizational Affiliation
Grupo Oncológico Gallego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Centro Oncológico de Galicia
City
La Coruña
State/Province
Galicia
ZIP/Postal Code
15009
Country
Spain
Facility Name
Complejo Hospitalario de Ourense
City
Ourense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Xeral Cies
City
Vigo
State/Province
Galicia
ZIP/Postal Code
36204
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer

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