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

Sponsors and Collaborators:	Grupo Oncológico Gallego Cephalon Pivotal S.L.
Information provided by:	Grupo Oncológico Gallego
ClinicalTrials.gov Identifier:	NCT00721747

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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

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:	June 2014
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Unique arm: Experimental 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 and older
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.Bilirubine < 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 metylprednisolone 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

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

Locations

Spain, Galicia
Complejo Hospitalario de Ourense
Ourense, Galicia, Spain, 32005
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Hospital Juan Canalejo
La Coruña, Galicia, Spain, 15006
Centro Oncológico de Galicia
La Coruña, Galicia, Spain, 15009
Hosital Xeral Calde
Lugo, Galicia, Spain, 27004
Hospital Xeral Cies
Vigo, Galicia, Spain, 36204
Hospital Do Meixoeiro, Vigo
Pontevedra, Galicia, Spain, 36214
Hospital Clínica Povisa
Pontevedra, Galicia, Spain, 36211
Spain, León
Hospital Virgen Blanca
Leon, León, Spain, 24071

Sponsors and Collaborators

Grupo Oncológico Gallego

Cephalon

Pivotal S.L.

Investigators

Principal Investigator:

Jesús García Mata, MD

Grupo Oncológico Gallego

More Information

Responsible Party:	GRUPO ONCOLÓGICO GALLEGO ( Rafael López López )
Study ID Numbers:	GOG/2007-01, 2007-005173-56
Study First Received:	July 23, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00721747
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Grupo Oncológico Gallego:

breast cancer patients her2 negative pathological responses

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms

Cyclophosphamide
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009