Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years
- Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
- Lesion bigger than 2cm.
- life expectancy > 12 weeks.
- Normal Heart function (LVEF>55%)
- Patient should give his/her signed, written informed consent.
Exclusion Criteria:
- Previous chemotherapy treatment.
- Previous treatment with HER2 or VEGF inhibitors.
- Pulmonary disease not controlled.
- Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
- Antecedents of coagulopathy or clinically significant thrombosis.
- Major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study.
- Peripheral Neuropathy > CTC 2 at inclusion.
- Altered renal function a. Creatinine > 2.0 mg/dL or 177 mmol/L. b.Proteinuria > 2+ with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h.
- Daily chronic treatment with corticosteroids
- Daily chronic treatment with aspirin (> 325 mg/day) o clopidogrel (> 75 mg/day)
- Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage.
- Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion.
- Active infection to be treated with iv antibiotics
- Serious injury not curing, peptic ulcer or bone fracture.
- Pregnant or active sexual patient not using contraceptive methods. or lactating woman
- Current or recent treatment with another IMP or participation in another clinical trial (30 days before inclusion)
- Another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
Sites / Locations
- Complejo Hospital Costa DelRecruiting
- Hospital Ramón Y CajalRecruiting
- Hospital UniversitarioRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Arm Description
Outcomes
Primary Outcome Measures
Pathologic response in breast and axilla
Secondary Outcome Measures
To evaluate tumor markers as potential predictors of the pathologic response
Full Information
NCT ID
NCT01321775
First Posted
March 23, 2011
Last Updated
March 23, 2011
Sponsor
Hospital Universitario Madrid Sanchinarro
1. Study Identification
Unique Protocol Identification Number
NCT01321775
Brief Title
Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
Official Title
Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Madrid Sanchinarro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Intervention Description
Neo-adjuvant doses (12 weeks):
Bevacizumab: 15mg/Kg every 3 weeks Trastuzumab: 4 mg/Kg (First dose) - 2mg/Kg every week. Paclitaxel: 80mg/m2 every week.
Adjuvant doses:
Trastuzumab: 8mg/Kg(first dose)- 6mg/Kg every 3 weeks (At least 9 months) Cyclophosphamide: 600mg/m2 every 3 weeks (9 months) Doxorubicin Liposomal: 50mg/m2 every 3 weeks (3 months)
Primary Outcome Measure Information:
Title
Pathologic response in breast and axilla
Time Frame
16 weeks average
Secondary Outcome Measure Information:
Title
To evaluate tumor markers as potential predictors of the pathologic response
Time Frame
baseline and 16 weeks average
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 years
Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
Lesion bigger than 2cm.
life expectancy > 12 weeks.
Normal Heart function (LVEF>55%)
Patient should give his/her signed, written informed consent.
Exclusion Criteria:
Previous chemotherapy treatment.
Previous treatment with HER2 or VEGF inhibitors.
Pulmonary disease not controlled.
Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
Antecedents of coagulopathy or clinically significant thrombosis.
Major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study.
Peripheral Neuropathy > CTC 2 at inclusion.
Altered renal function a. Creatinine > 2.0 mg/dL or 177 mmol/L. b.Proteinuria > 2+ with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h.
Daily chronic treatment with corticosteroids
Daily chronic treatment with aspirin (> 325 mg/day) o clopidogrel (> 75 mg/day)
Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage.
Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion.
Active infection to be treated with iv antibiotics
Serious injury not curing, peptic ulcer or bone fracture.
Pregnant or active sexual patient not using contraceptive methods. or lactating woman
Current or recent treatment with another IMP or participation in another clinical trial (30 days before inclusion)
Another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
Facility Information:
Facility Name
Complejo Hospital Costa Del
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Perez, MD
Phone
0034951 97 66 69
Email
dipema2026@gmail.com
First Name & Middle Initial & Last Name & Degree
Diego Perez, MD
Facility Name
Hospital Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelia Martinez, MD
Phone
003491 336 80 00
Email
mjnoelia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Noelia Martinez, MD
Facility Name
Hospital Universitario
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Garcia, MD
Phone
003491 756 78 50
Email
lauraestevez@hospitaldemadrid.com
First Name & Middle Initial & Last Name & Degree
Laura Garcia, MD
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
We'll reach out to this number within 24 hrs