Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment docetaxel, liposomal doxorubicine and cyclophosphamide
Phase phase 2
Sponsor Grupo Oncológico Gallego
Collaborator Pivotal S.L.
Start date January 2008
End date January 2011
Trial size 83 participants
Trial identifier NCT00721747, 2007-005173-56, GOG/2007-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
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 Outcomes

Measure
Determine proportion of Pathological complete responses
time frame: At the end of the treatment, after Surgery.

Secondary Outcomes

Measure
Determine proportion of clinical responses
time frame: At the end of the treatment
Describe treatment safety
time frame: At the end of the treatment
Determine proportion of conservative breast surgery
time frame: At the end of the study
Evaluate disease free survival
time frame: At the end of the treatment
Evaluate Overall survival
time frame: At the end of the treatment
Evaluate gene patterns regarding prediction of treatment response
time frame: At the end of the treatment

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

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
Principal investigator Jesús García Mata, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Grupo Oncológico Gallego.