Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MRI determinants of pathological complete response
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Norway: Norwegian Medicines Agency
Study ID:
ML21744
NCT ID:
NCT00773695
Start Date:
November 2008
Completion Date:
January 2023
Related Keywords:
- Breast Cancer
- Breast Neoplasms