Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Grupo Oncológico Gallego
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
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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:
- ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed)
- 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:
- skin cancer(no melanoma)
- In situ cervix Carcinoma
- Ipsilateral in situ ductal carcinoma
- In situ lobular in situ carcinoma
- 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
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 May 19, 2013