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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Marbella, Malaga, Spain, 29600
Hospital Ramón Y Cajal
Madrid, Spain, 28034
Hospital Universitario
Madrid, Spain, 28050
Sponsors and Collaborators
Hospital Universitario Madrid Sanchinarro
  More Information

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

ClinicalTrials.gov processed this record on December 08, 2016