Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

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Lilly

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Gemcitabine
Drug: docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191243
B9E-MC-S241 (Other Identifier)
5758

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

237 participants in 2 patient groups

A
Experimental group
Treatment:
Drug: docetaxel
Drug: Gemcitabine
B
Experimental group
Treatment:
Drug: docetaxel
Drug: Gemcitabine

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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