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

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 Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide

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 Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08906
      • Hospital de Hospitalet
  • Galicia
    • La Coruña, Galicia, Spain, 15006
      • Hospital Juan Canalejo
    • La Coruña, Galicia, Spain, 15009
      • Centro Oncologico de Galicia
    • Ourense, Galicia, Spain, 32005
      • Complejo Hospitalario de Ourense
    • Santiago de Compostela, Galicia, Spain, 15706
      • Hospital Clínico Universitario de Santiago
    • Vigo, Galicia, Spain, 36204
      • Hospital Xeral Cíes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unique arm; 4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine proportion of Pathological complete responses	At the end of the treatment, after Surgery.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Grupo Oncológico Gallego
• Collaborators: Pivotal S.L.
• Investigators: Principal Investigator: Jesús García Mata, MD, Grupo Oncológico Gallego

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: breast cancer patients her2 negative pathological responses
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: GOG/2007-01; 2007-005173-56