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A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules


Phase 3
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer (MBC)

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Trial Information

A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules


Inclusion Criteria:



- Histologic diagnosis of metastatic breast cancer (MBC).

- Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since
completion of the regimen.

- Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an
anthracycline if not clinically contraindicated.

- Patients with measurable disease.

- Previous hormonal therapy for adjuvant setting or metastatic disease.

Exclusion Criteria:

- Previous chemotherapy for MBC

- Previous chemotherapy with gemcitabine in any setting of disease

- Patient candidable to treatment with trastuzumab.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progressive Disease (TTPD) by Treatment Schedule

Outcome Description:

TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.

Outcome Time Frame:

Baseline up to 49.84 months

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Chair

Investigator Affiliation:

Eli Lilly and Company

Authority:

Italy: Ministry of Health

Study ID:

9846

NCT ID:

NCT00236899

Start Date:

September 2005

Completion Date:

August 2010

Related Keywords:

  • Metastatic Breast Cancer (MBC)
  • Breast Neoplasms

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