A Study of Avastin (Bevacizumab) in Combination With Neoadjuvant Treatment Regimens in Patients With Primary HER2 Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Norwegian Radium Hospital
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773695
First received: October 15, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This 2 arm study will evaluate the effect of Avastin, in combination with chemot herapy or endocrine therapy, as preoperative treatment in patients with HER2 neg ative breast cancer. Patients will be randomized to receive either chemotherapy (FEC100 for 4 x 3weekly cycles or endocrine therapy (an aromatase inhibitor dail y for 24 weeks)with or without Avastin (15mg/kg iv every 3 weeks).The anticipate d time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Placebo
Drug: Standard chemotherapy or endocrine therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, ph II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadj Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Ref to the Obtained Responses in Patients With Large Primary HER2 Neg Breast Cancers

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • MRI determinants of pathological complete response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Molecular changes in protein kinase, mRNA/miRNA and protein expression; SNP profiles predicting treatment response; treatment-induced changes in tumor cells. [ Time Frame: Thoughout study ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: November 2008
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: Standard chemotherapy or endocrine therapy
As prescribed
Placebo Comparator: 2 Drug: Placebo
iv every 3 weeks
Drug: Standard chemotherapy or endocrine therapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2-negative breast cancer, >=2.5cm in size;
  • ECOG/WHOperformance status <=2;
  • normal baseline cardiac function (LVEF).

Exclusion Criteria:

  • stage IV (metastatic) disease;
  • previous treatment for localized breast cancer < 24 months from diagnosis of present breast cancer;
  • other previous or current cancer except for basal cell cancer or in situ cervical cancer;
  • current or recent use of aspirin (>325mg/day);
  • clinically significant cardiovascular disease.
  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: NCT00773695

Locations
Norway
Oslo, Norway, 0379
Oslo, Norway, 0407
Trondheim, Norway, 7000
Sponsors and Collaborators
Hoffmann-La Roche
Norwegian Radium Hospital
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773695     History of Changes
Other Study ID Numbers: ML21744
Study First Received: October 15, 2008
Last Updated: July 7, 2014
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014