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Completed

NCT Number: NCT00191815

Combination Chemotherapy for Metastatic Breast Cancer

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

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Key information

Conditions

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

Age range

18 year–75 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 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician, Munich, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • You are female in the age of 18 to 75 years old.
  • You have been diagnosed with the metastatic breast cancer.
  • You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
  • You must sign this informed consent form

Exclusion criteria

  • You are pregnant or breastfeeding.
  • Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
  • You have been diagnosed with serious concomitant or acute infectious disease.
  • You have used experimental medications within the last month.

Treatment and study plan

Gemcitabine

Drug

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

Cisplatin

Drug

Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

Primary outcomes

  1. Objective Tumor Response

    Time frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)

    Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary outcomes

  1. Duration of Response

    Time frame: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

    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.

  2. Time to Progressive Disease

    Time frame: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

    Defined as the time from study enrollment to the first date of disease progression.

  3. Time to Treatment Failure

    Time frame: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

    Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.

  4. Survival Time

    Time frame: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

    Overall survival is the duration from enrollment to death due to any cause.

  5. Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination

    Time frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)

    The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).

  6. Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades

    Time frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)

    Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).

  7. Number of Deaths

    Time frame: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

  8. Number of Participants With Adverse Events Leading to Discontinuation

    Time frame: Baseline through eight 21-day cycles

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

Important dates

Study start
2002
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Nov 11, 2009

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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