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

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Trial Information


Inclusion Criteria:



- female patients, age >/=18 years

- advanced, inflammatory or early stage unilateral invasive breast cancer

- HER2-positive breast cancer

- baseline LVEF >/=55%

Exclusion Criteria:

- metastatic disease (Stage IV) or bilateral breast cancer

- previous anticancer therapy or radiotherapy for any malignancy

- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma

- clinically relevant cardiovascular disease

- current chronic treatment with corticosteroids of >10mg methylprednisolone or
equivalent

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:

Tolerability during neoadjuvant treatment: symptomatic cardiac events, LVEF

Outcome Time Frame:

throughout cycles 1-6, complete cardiac questionnaire every 3 weeks, LVEF cycles 2, 4 and 6

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO22280

NCT ID:

NCT00976989

Start Date:

December 2009

Completion Date:

August 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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