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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Hospital Universitario Madrid Sanchinarro.
Recruitment status was Recruiting
Information provided by:
Hospital Universitario Madrid Sanchinarro
First received: March 23, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
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).
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Pathologic response in breast and axilla [ Time Frame: 16 weeks average ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate tumor markers as potential predictors of the pathologic response [ Time Frame: baseline and 16 weeks average ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
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.
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)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01321775
|Complejo Hospital Costa Del
|Marbella, Malaga, Spain, 29600 |
|Contact: Diego Perez, MD 0034951 97 66 69 firstname.lastname@example.org |
|Principal Investigator: Diego Perez, MD |
|Hospital Ramón Y Cajal
|Madrid, Spain, 28034 |
|Contact: Noelia Martinez, MD 003491 336 80 00 email@example.com |
|Principal Investigator: Noelia Martinez, MD |
|Madrid, Spain, 28050 |
|Contact: Laura Garcia, MD 003491 756 78 50 firstname.lastname@example.org |
|Principal Investigator: Laura Garcia, MD |
Hospital Universitario Madrid Sanchinarro
||Sofia Perea, Fundación Hospital de Madrid
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 23, 2011
||March 23, 2011
||Spain: Agencia Española de Medicamentos y Productos Sanitarios
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating