Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Eli Lilly and Company60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

gemcitabineDRUG

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression

paclitaxelDRUG

175 mg/m2, intravenous (IV), every 21 days until disease progression

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

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

Guangzhou, China

Shanghai, China

Outcomes

Primary Outcomes

Best Overall Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Time frame: 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)

Secondary Outcomes

Time to Treatment Failure

Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.

Time frame: baseline to stopping treatment

Progression-Free Survival

Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.

Time frame: 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)

Duration of Response

Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.