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


Phase 2
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Diagnosis of breast cancer

- Evidence that cancer has spread beyond its original location or has come back and
cannot be removed by surgery

- No more than one prior treatment for advanced disease

- Her2 positive status

- Adequate liver and kidney function

- No remaining severe harmful effects to prior treatments

Exclusion Criteria:

- Certain heart condition

- Pregnant Women

- History of another cancer except some skin cancers and cervical cancer

- Taking other treatments for your cancer at the time you enter the trial

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:

Tumor response measured

Outcome Time Frame:

every 2 cycles during treatment phase

Safety Issue:

No

Principal Investigator

Eric Winer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

TCD10037

NCT ID:

NCT00387907

Start Date:

October 2006

Completion Date:

March 2008

Related Keywords:

  • Advanced Breast Cancer
  • Breast Cancer
  • Metastatic Breast Cancer
  • Herceptin
  • Taxane
  • Breast Cancer
  • Breast Neoplasms

Name

Location
Sanofi-Aventis Administrative Office Malvern, Pennsylvania  19355