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Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)


Inclusion Criteria:



- Metastatic breast cancer (MBC)

- HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ
Hybridization) positive or IHC (Immunohistochemistry) 3+

- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

- Adequate organs functions

Exclusion Criteria:

- More than one previous chemotherapy regimen for metastatic disease

- Cardiac dysfunction

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (best overall response under treatment)

Outcome Time Frame:

study period

Safety Issue:

No

Principal Investigator

Henri Roche, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud - Toulouse - France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TCD6595

NCT ID:

NCT00386685

Start Date:

July 2006

Completion Date:

January 2011

Related Keywords:

  • Breast Neoplasms
  • Cancer
  • Breast
  • metastatic breast cancer
  • Breast Neoplasms
  • Neoplasms

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