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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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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

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