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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide

• Registration Number: NCT00721747
• Lead Sponsor: Grupo Oncológico Gallego

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Primary Completion: 2011-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 83

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unique arm	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

Primary Outcome Measures

Name	Time	Method
Determine proportion of Pathological complete responses	At the end of the treatment, after Surgery.

Secondary Outcome Measures

Name	Time	Method
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
Evaluate gene patterns regarding prediction of treatment response	At the end of the treatment

Trial Locations

Locations (6)

Complejo Hospitalario de Ourense; 🇪🇸 Ourense, Galicia, Spain

Hospital de Hospitalet; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Juan Canalejo; 🇪🇸 La Coruña, Galicia, Spain

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Galicia, Spain

Hospital Xeral Cies; 🇪🇸 Vigo, Galicia, Spain

Centro Oncológico de Galicia; 🇪🇸 La Coruña, Galicia, Spain