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A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer


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

Thank you

Trial Information

A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer


Inclusion Criteria:



- female patients, >=18 years of age;

- locally advanced, inflammatory or early stage invasive breast cancer;

- HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

- metastatic disease (Stage IV) or bilateral breast cancer;

- previous anticancer therapy or radiotherapy for any malignancy;

- other malignancy, other than cancer in situ of the cervix, or basal cell cancer;

- insulin-dependent diabetes;

- clinically relevant 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:

Pathological complete response rate

Outcome Time Frame:

Post-surgery

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: AIFA (Agenzia Italiana Farmaco)

Study ID:

WO20697

NCT ID:

NCT00545688

Start Date:

December 2007

Completion Date:

February 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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