Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Taxane

Antimetabolites

1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days

gemcitabine

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

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

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

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.

For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.

Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.

Results are reported as number of participants alive at one year.

maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.

Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.

Eli Lilly and Company

Chief Medical Officer

Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.

Dose Level 1

Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.

Dose Level 2

Total

Age Continuous

Sex: Female, Male

Japan

Region of Enrollment

0 - Fully Active

1 - Ambulatory, Restricted Strenuous Activity

Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Eastern Cooperative Oncology Group (ECOG) Performance Status

Unknown

Human Epidermal Growth Factor Receptor 2 Expression Status

None

Present

Presence of Estrogen Hormone Receptor

Lung

Bone

Liver

Brain

Lymph Node

Skin

Other Sites

Metastasis could occur in more than one site, resulting in a higher sum for all categories in the arm/group than the overall number of participants in the arm/group.

Presence of Metastasis

Presence of Progesterone Hormone Receptor

<3 months

≥3 months and <6 months

≥6 months and <1 year

≥1 year and <2 years

≥2 years and <3 years

≥3 years before

Time of Latest Chemotherapy Completion

<1 year

≥3 years and <4 years

≥4 years and < 5 years

≥5 to <10 years

No Recurrence

Time to Recurrence

Height

Weight

Complete Response

Partial Response

Long Stable Disease

Stable Disease

Progressive Disease

Not Evaluable

Tumor Response

The 5 responding participants (complete response and partial response) at Dose Level 2.

Duration of Response

Time to Progressive Disease

Survival at 1 Year

12 participants with a mean gemcitabine dose of 1120 milligrams per square meter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen	NCT00191269	Metastatic Brea...	gemcitabine gemcitabine	20 Years - 74 Years	Eli Lilly and Company
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen	NCT00191269	Metastatic Brea...	gemcitabine gemcitabine	20 Years - 74 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for after

Every month we try and update this database with for after cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for after

Every month we try and update this database with for after cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for after cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.