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Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure


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

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Trial Information

Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure


Inclusion Criteria:



- Female patients with histological or cytological proven diagnosis of breast cancer

- Stage IV disease

- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale

- Patients had to have previously received anthracycline based regimens as a adjuvant
therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic
disease

- Adequate organ function

Exclusion Criteria:

- Prior chemotherapy for metastatic disease

- Previous radiation therapy is allowed but must not have included whole pelvis
radiation

- Known or suspected brain metastasis. Serious concomitant disorders that would
compromise the safety of the patient or compromise the patient's ability to complete
the study, at the discretion of the investigator

- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))

- Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History
of significant neurological or mental disorder, including seizures or dementia

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:

Best Overall Response

Outcome Description:

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Outcome Time Frame:

baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9:00 AM to 5:00 PM Est Time (UTC/GMT - 5 hours)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

China: Food and Drug Administration

Study ID:

7451

NCT ID:

NCT00191854

Start Date:

March 2005

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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