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

Grupo Oncológico Gallego

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00721747

2007-005173-56

GOG/2007-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Unique arm

Experimental group

Description:

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

Treatment:

Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide