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

March 23, 2011 updated by: Hospital Universitario Madrid Sanchinarro

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramón y Cajal
        • Principal Investigator:
          • Noelia Martinez, MD
        • Contact:
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario
        • Contact:
        • Principal Investigator:
          • Laura Garcia, MD
    • Malaga
      • Marbella, Malaga, Spain, 29600
        • Recruiting
        • Complejo Hospital Costa Del
        • Contact:
        • Principal Investigator:
          • Diego Perez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic response in breast and axilla
Time Frame: 16 weeks average
16 weeks average

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate tumor markers as potential predictors of the pathologic response
Time Frame: baseline and 16 weeks average
baseline and 16 weeks average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Madrid Sanchinarro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVANTHER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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