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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321775
Recruitment Status : Unknown
Verified June 2010 by Hospital Universitario Madrid Sanchinarro.
Recruitment status was:  Recruiting
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
Information provided by:
Hospital Universitario Madrid Sanchinarro

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet 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)

Primary Outcome Measures :
  1. Pathologic response in breast and axilla [ Time Frame: 16 weeks average ]

Secondary Outcome Measures :
  1. To evaluate tumor markers as potential predictors of the pathologic response [ Time Frame: baseline and 16 weeks average ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321775

Complejo Hospital Costa Del Recruiting
Marbella, Malaga, Spain, 29600
Contact: Diego Perez, MD    0034951 97 66 69   
Principal Investigator: Diego Perez, MD         
Hospital Ramón Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Noelia Martinez, MD    003491 336 80 00   
Principal Investigator: Noelia Martinez, MD         
Hospital Universitario Recruiting
Madrid, Spain, 28050
Contact: Laura Garcia, MD    003491 756 78 50   
Principal Investigator: Laura Garcia, MD         
Sponsors and Collaborators
Hospital Universitario Madrid Sanchinarro

Responsible Party: Sofia Perea, Fundación Hospital de Madrid Identifier: NCT01321775     History of Changes
Other Study ID Numbers: AVANTHER
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic