Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Eli Lilly and Company62 enrolled

Overview

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

gemcitabineDRUG

Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1

paclitaxelDRUG

Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically and/or cytologically confirmed breast cancer * Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen * To have at least one measurable region * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * To have adequate organ function (bone marrow, liver and renal function) Exclusion Criteria: * To have interstitial pneumonia or pulmonary fibrosis * To have inflammatory breast cancer * Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery * To have brain metastases with symptoms * To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)

Locations (15)

Outcomes

Primary Outcomes

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. Responders are patients with complete response or partial response.

Time frame: baseline to measured progressive disease

Secondary Outcomes

Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Time frame: time of response to progressive disease

Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.

Time frame: baseline to measured progressive disease

Number of Participants Alive at One Year (1-Year Survival)

Time frame: baseline to date of death from any cause, evaluated at 1 year

Pharmacokinetics - Maximum Plasma Concentration (Cmax)

Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.

Time frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Pharmacokinetics - Area Under the Concentration Curve (AUC)

Area under the concentration curve from time zero to infinity.

Time frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Data from ClinicalTrials.gov

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

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.

Aichi, Japan

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Gunma, Japan

Hiroshima, Japan

Hokkaido, Japan

Kagoshima, Japan

Kanagawa, Japan

Kumamoto, Japan

...and 5 more locations