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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
Grupo Oncológico Gallego
ClinicalTrials.gov Identifier:
NCT00721747
First received: July 23, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Grupo Oncológico Gallego:

Primary Outcome Measures:
  • Determine proportion of Pathological complete responses [ Time Frame: At the end of the treatment, after Surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine proportion of clinical responses [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Describe treatment safety [ Time Frame: At the end of the treatment ] [ Designated as safety issue: Yes ]
  • Determine proportion of conservative breast surgery [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Evaluate disease free survival [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Evaluate Overall survival [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]
  • Evaluate gene patterns regarding prediction of treatment response [ Time Frame: At the end of the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 83
Study Start Date: January 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721747

Locations
Spain
Hospital de Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
Hospital Juan Canalejo
La Coruña, Galicia, Spain, 15006
Centro Oncológico de Galicia
La Coruña, Galicia, Spain, 15009
Complejo Hospitalario de Ourense
Ourense, Galicia, Spain, 32005
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Hospital Xeral Cies
Vigo, Galicia, Spain, 36204
Sponsors and Collaborators
Grupo Oncológico Gallego
Pivotal S.L.
Investigators
Principal Investigator: Jesús García Mata, MD Grupo Oncológico Gallego
  More Information

No publications provided

Responsible Party: Grupo Oncológico Gallego
ClinicalTrials.gov Identifier: NCT00721747     History of Changes
Other Study ID Numbers: GOG/2007-01, 2007-005173-56
Study First Received: July 23, 2008
Last Updated: March 15, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Oncológico Gallego:
breast cancer patients her2 negative pathological responses

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 22, 2014