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Completed

NCT Number: NCT00191243

Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine.

Aim of the study is to assess the optimal dosage and safety in this setting.

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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–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Helsinki, Finland

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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 verified diagnosis of breast carcinoma, at first diagnosis
  • restricted previous adjuvant chemotherapy (completed >6 months prior the study)
  • measurable and/or non-measurable disease
  • previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
  • performance status 0-2 (WHO, Zubrod)
  • adequate bone marrow reserve defined
  • adequate liver / renal functions defined

Exclusion criteria

  • any prior systematic chemotherapy for metastatic breast cancer
  • expected survival time less than 12 weeks
  • past or current history of malignant neoplasm other than breast carcinoma
  • except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
  • known brain metastases/leptomeningeal involvement
  • active uncontrolled infection
  • symptomatic peripheral neuropathy > grade 2 according to NCI
  • patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
  • concomitant illness that is contraindication to the use of corticosteroids
  • other concomitant serious illness or medical condition, which may worsen due to the treatment

Treatment and study plan

Gemcitabine

Drug

A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression

B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure

Other names: LY188011, Gemzar

docetaxel

Drug

A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine

B: 80 mg/m2, IV, q 21 days until treatment failure

Primary outcomes

  1. Time to treatment failure (TTTF)

    Time frame: baseline to stopping treatment

Secondary outcomes

  1. Response rate

    Time frame: baseline to measured progressive disease

  2. Duration of response

    Time frame: time of response to progressive disease

  3. Overall survival

    Time frame: baseline to date of death from any cause

  4. Time to progressive disease

    Time frame: baseline to measured progressive disease

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

Important dates

Study start
2002
Primary completion
2007
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Sep 12, 2019

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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