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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00721747
• Other study ID #: GOG/2007-01
• Secondary ID: 2007-005173-56
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: March 15, 2012
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: March 2012
• Source: Grupo Oncológico Gallego
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: January 2015
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Centro Oncológico de Galicia	La Coruña	Galicia
Spain	Hospital Juan Canalejo	La Coruña	Galicia
Spain	Complejo Hospitalario de Ourense	Ourense	Galicia
Spain	Hospital Clínico Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Hospital Xeral Cies	Vigo	Galicia

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Oncológico Gallego	Pivotal S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine proportion of Pathological complete responses		At the end of the treatment, after Surgery.	No
Secondary	Determine proportion of clinical responses		At the end of the treatment	No
Secondary	Describe treatment safety		At the end of the treatment	Yes
Secondary	Determine proportion of conservative breast surgery		At the end of the study	No
Secondary	Evaluate disease free survival		At the end of the treatment	No
Secondary	Evaluate Overall survival		At the end of the treatment	No
Secondary	Evaluate gene patterns regarding prediction of treatment response		At the end of the treatment	No