Breast CancerPhase 2NCT00191243
Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
A Phase 2 study testing Gemcitabine and docetaxel in people with Breast Cancer, run by Eli Lilly and Company at 8 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gemcitabine and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 8 sitesFinland
- Study dates
- Mar 2002to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Finland8 sites
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
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
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.
Jyväskylä
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.
Lappeenranta
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.
Oulu
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.
Pikonlinna
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.
Pori
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.
Turku
About this study
Official title: A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic 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.
- Conditions
- Breast Cancer
- Being tested
- Gemcitabine, docetaxel
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called LY188011, Gemzar
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
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Gemcitabine; Drug: docetaxel |
| B | Experimental | Not described Receives: Drug: Gemcitabine; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTTF)
Measured: baseline to stopping treatment
Secondary outcomes (4)
Response rate
Measured: baseline to measured progressive disease
Duration of response
Measured: time of response to progressive disease
Overall survival
Measured: baseline to date of death from any cause
Time to progressive disease
Measured: baseline to measured progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionAug 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191243
- Sponsor's protocol ID
- 5758
- Other IDs
- B9E-MC-S241
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2005
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
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.
PubMed 19819914
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00191243
- Acronym / sponsor ID
- 5758
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gemcitabine, Drug: docetaxel |
| B | Experimental | Drug: Gemcitabine, Drug: docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
- known brain metastases/leptomeningeal involvement
- active uncontrolled infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: LY188011, GemzarA: 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 | Drug | A, B |
| docetaxelA: 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 | Drug | A, B |
Primary outcome
Time to treatment failure (TTTF)
Time frame: baseline to stopping treatment
4 secondary outcomes
Response rate
Time frame: baseline to measured progressive disease
Duration of response
Time frame: time of response to progressive disease
Overall survival
Time frame: baseline to date of death from any cause
Time to progressive disease
Time frame: baseline to measured progressive disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Results publication: PubMed 19819914Joensuu 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and docetaxel in people with Breast Cancer, run by Eli Lilly and Company at 8 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (TTTF) (time frame: baseline to stopping treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00191243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.