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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01321775
• Other study ID #: AVANTHER
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2011
• Last updated: March 23, 2011
• Start date: August 2009
• Est. completion date: November 2013

Study information

• Verified date: June 2010
• Source: Hospital Universitario Madrid Sanchinarro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
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)

Locations

Country	Name	City	State
Spain	Hospital Ramón Y Cajal	Madrid
Spain	Hospital Universitario	Madrid
Spain	Complejo Hospital Costa Del	Marbella	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Madrid Sanchinarro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic response in breast and axilla		16 weeks average	No
Secondary	To evaluate tumor markers as potential predictors of the pathologic response		baseline and 16 weeks average	No