Breast CancerPhase 2NCT00191789
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
A Phase 2 study testing gemcitabine, doxorubicin and cisplatin in people with Breast Cancer, run by Eli Lilly and Company at 3 sites in India.
Trial summary
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gemcitabine, doxorubicin and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesIndia
- Study dates
- Feb 2003to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast carcinoma
- No previous chemotherapy, with bidimensionally measurable locally advanced disease
- Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.
Who cannot join
- Inflammatory breast cancer
- Pregnancy and Breast-feeding
- Serious concomitant disorder or infection
- Previous cancer within the last 5 years or a second primary malignancy.
Trial locations and contacts
3 sites in 1 country.
India3 sites
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (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.
Delhi, 110029
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (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.
Pune, Maharashtra, 411001
For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (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.
Vellore, Tamil Nadu, 632004
About this study
Official title: Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
- Conditions
- Breast Cancer
- Being tested
- gemcitabine, doxorubicin, cisplatin, surgery
- 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
1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)
doxorubicinDrug
60 mg/m^2, IV, every 21 days x 4 cycles (1-4)
cisplatinDrug
70 mg/m^2, IV, every 21 days x 4 cycles (5-8)
surgeryProcedure or surgery
Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine+Doxorubicin+Cisplatin+Surgery | Experimental | Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. Receives: Drug: gemcitabine; Drug: doxorubicin; Drug: cisplatin; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
Measured: tumor assessment at baseline and during surgery after eight 21-day treatment cycles
Secondary outcomes (5)
Summary of Deaths During Study
Measured: baseline through last cycle on study drug (eight 21-day cycles)
Progression Free Survival (PFS)
PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.
Measured: baseline to measured progressive disease or death from any cause (up to 68 months)
Overall Survival
Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.
Measured: baseline to date of death from any cause up to 68 months
Time to Treatment Failure
Time to treatment failure was 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. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.
Measured: baseline to stopping treatment (up to 68 months)
Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.
Measured: baseline, after eight 21-day cycles of study drug
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 startFeb 2003
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191789
- Sponsor's protocol ID
- 7117
- Other IDs
- B9E-MC-S329
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT00191789
- Acronym / sponsor ID
- 7117
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 22 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine+Doxorubicin+Cisplatin+Surgery | Experimental | Drug: gemcitabine, Drug: doxorubicin, Drug: cisplatin, Procedure: surgeryGemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast carcinoma
- No previous chemotherapy, with bidimensionally measurable locally advanced disease
- Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.
Key exclusion criteria (4 listed)
- Inflammatory breast cancer
- Pregnancy and Breast-feeding
- Serious concomitant disorder or infection
- Previous cancer within the last 5 years or a second primary malignancy.
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, Gemzar1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8) | Drug | Gemcitabine+Doxorubicin+Cisplatin+Surgery |
| doxorubicin60 mg/m^2, IV, every 21 days x 4 cycles (1-4) | Drug | Gemcitabine+Doxorubicin+Cisplatin+Surgery |
| cisplatin70 mg/m^2, IV, every 21 days x 4 cycles (5-8) | Drug | Gemcitabine+Doxorubicin+Cisplatin+Surgery |
| surgerySurgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. | Procedure or surgery | Gemcitabine+Doxorubicin+Cisplatin+Surgery |
Primary outcome
Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
Time frame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
5 secondary outcomes
Summary of Deaths During Study
Time frame: baseline through last cycle on study drug (eight 21-day cycles)
Progression Free Survival (PFS)
Time frame: baseline to measured progressive disease or death from any cause (up to 68 months)
Overall Survival
Time frame: baseline to date of death from any cause up to 68 months
Time to Treatment Failure
Time frame: baseline to stopping treatment (up to 68 months)
Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
Time frame: baseline, after eight 21-day cycles of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST) study director
Eli Lilly and Company
3 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, doxorubicin and cisplatin in people with Breast Cancer, run by Eli Lilly and Company at 3 sites in India.
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 3 inclusion and 4 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 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) (time frame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2010; AzTrials last refreshed its copy on 4 Nov 2026.