Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

237

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started Mar 2002

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.1 years study duration

Study Start

First participant enrolled

March 1, 2002

Completed

3.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

5.4 years

First QC Date

September 12, 2005

Last Update Submit

September 10, 2019

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

Time to treatment failure (TTTF)
baseline to stopping treatment

Secondary Outcomes (4)

Response rate
baseline to measured progressive disease
Duration of response
time of response to progressive disease
Overall survival
baseline to date of death from any cause
Time to progressive disease
baseline to measured progressive disease

Study Arms (2)

A

EXPERIMENTAL

Drug: GemcitabineDrug: docetaxel

B

EXPERIMENTAL

Drug: GemcitabineDrug: docetaxel

Interventions

GemcitabineDRUG

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

Also known as: LY188011, Gemzar

docetaxelDRUG

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

Eligibility Criteria

Age18 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (8)

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.

Hämeenlinna, Finland

Location

Helsinki, Finland

Location

Jyväskylä, Finland

Location

Lappeenranta, Finland

Location

Oulu, Finland

Location

Pikonlinna, Finland

Location

Pori, Finland

Location

Turku, Finland

Location

Related Publications (1)

Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhonen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol. 2010 May;21(5):968-73. doi: 10.1093/annonc/mdp397. Epub 2009 Oct 9.
PMID: 19819914RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GemcitabineDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2002

Primary Completion

August 1, 2007

Study Completion

April 1, 2009

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

FI(8)

Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations