Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316199
• Other study ID #: 9803
• Secondary ID: B9E-MC-JHST
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2006
• Last updated: June 12, 2009
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.

• Unresectable, locally recurrent breast cancer or stage IV disease.

• Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

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

• Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria:

• Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.

• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.

• Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.

• Active infection or other serious condition.

• Pregnant or breastfeeding.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• gemcitabine
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression
• paclitaxel
175 mg/m2, intravenous (IV), every 21 days until disease progression

Locations

Country	Name	City	State
China	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Beijing
China	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Guang Zhou
China	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Tumor Response		baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)	No
Secondary	Time to Treatment Failure		baseline to stopping treatment	Yes
Secondary	Progression-Free Survival		baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)	No
Secondary	Duration of Response		time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)	No
Secondary	Overall Survival Probability		baseline to date of death from any cause	Yes

External Links

•   Lilly Clinical Trial Registry