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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005173-56 |
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| Name | Class |
|---|---|
| Pivotal S.L. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel, Liposomal doxorubicine and Cyclophosphamide | Drug | 4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv |
| Measure | Description | Time Frame |
|---|---|---|
| Determine proportion of Pathological complete responses | At the end of the treatment, after Surgery. |
| Measure | Description | 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 |
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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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jesús García Mata, MD | Grupo Oncológico Gallego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08906 | Spain | ||
| Hospital Juan Canalejo |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| 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 |
| A Coruña |
| Galicia |
| 15006 |
| Spain |
| Centro Oncológico de Galicia | A Coruña | Galicia | 15009 | Spain |
| Complejo Hospitalario de Ourense | Ourense | Galicia | 32005 | Spain |
| Hospital Clínico Universitario de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Hospital Xeral Cies | Vigo | Galicia | 36204 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |