Clinical trial NCT00721747: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer patients her2 negative pathological responses
Lead sponsor: Grupo Oncológico Gallego
Sponsor class: OTHER
Collaborators: name: Pivotal S.L.
First posted: 2008-07-24
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Determine proportion of Pathological complete responses
timeFrame: At the end of the treatment, after Surgery.
Secondary outcomes:
measure: Determine proportion of clinical responses
timeFrame: At the end of the treatment
measure: Describe treatment safety
timeFrame: At the end of the treatment
measure: Determine proportion of conservative breast surgery
timeFrame: At the end of the study
measure: Evaluate disease free survival
timeFrame: At the end of the treatment
measure: Evaluate Overall survival
timeFrame: At the end of the treatment
measure: Evaluate gene patterns regarding prediction of treatment response
timeFrame: At the end of the treatment
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Hospitalet
state: Barcelona
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
state: Galicia
city: La Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: Galicia
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: Galicia
city: Vigo
country: Spain
facility: Hospital Xeral Cies
state: Galicia
Study officials:
affiliation: Grupo Oncológico Gallego
name: Jesús García Mata, MD
role: PRINCIPAL_INVESTIGATOR
References: