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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
Sponsor:
Information provided by:
Hospital Universitario Madrid Sanchinarro
ClinicalTrials.gov Identifier:
NCT01321775
First received: March 23, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Madrid Sanchinarro:

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: 44
Study Start Date: August 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321775

Locations
Spain
Complejo Hospital Costa Del Recruiting
Marbella, Malaga, Spain, 29600
Contact: Diego Perez, MD    0034951 97 66 69    dipema2026@gmail.com   
Principal Investigator: Diego Perez, MD         
Hospital Ramón Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Noelia Martinez, MD    003491 336 80 00    mjnoelia@hotmail.com   
Principal Investigator: Noelia Martinez, MD         
Hospital Universitario Recruiting
Madrid, Spain, 28050
Contact: Laura Garcia, MD    003491 756 78 50    lauraestevez@hospitaldemadrid.com   
Principal Investigator: Laura Garcia, MD         
Sponsors and Collaborators
Hospital Universitario Madrid Sanchinarro
  More Information

No publications provided

Responsible Party: Sofia Perea, Fundación Hospital de Madrid
ClinicalTrials.gov Identifier: NCT01321775     History of Changes
Other Study ID Numbers: AVANTHER
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Trastuzumab
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014