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OpenTrials
Completed

NCT Number: NCT00191269

Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically and/or cytologically confirmed breast cancer
  • Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
  • To have at least one measurable region
  • PS: 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 carcinoma
  • Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
  • To have brain metastasis with symptom
  • To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Treatment and study plan

Gemcitabine

Drug

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

Other names: LY188011, Gemzar

Primary outcomes

  1. Tumor Response

    Time frame: baseline to measured progressive disease

    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.

Secondary outcomes

  1. Duration of Response

    Time frame: time of response to progressive disease

    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.

  2. Time to Progressive Disease

    Time frame: baseline to measured progressive disease

    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.

  3. Survival at 1 Year

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

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

  4. Pharmacokinetics - Normalized Cmax

    Time frame: cycle 1

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

  5. Pharmacokinetics - Normalized Area Under the Curve

    Time frame: cycle 1

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Mar 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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