Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer | RxWiki

Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Breast Cancer
Intervention	Drug: gemcitabine Drug: doxorubicin Drug: cisplatin Procedure: surgery
Phase	Phase 2
Sponsor	Eli Lilly and Company
Responsible Party	Eli Lilly and Company
ClinicalTrials.gov Identifier	NCT00191789
First Received	September 12, 2005
Last Updated	July 21, 2010
Last verified	July 2010

Tracking Information[ + expand ][ + ]

First Received Date	September 12, 2005
Last Updated Date	July 21, 2010
Start Date	February 2003
Estimated Primary Completion Date	April 2009
Current Primary Outcome Measures	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] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Summary of Deaths During Study [Time Frame: baseline through last cycle on study drug (eight 21-day cycles)] [Designated as safety issue: Yes] Progression Free Survival (PFS) [Time Frame: baseline to measured progressive disease or death from any cause (up to 68 months)] [Designated as safety issue: No]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. Overall Survival [Time Frame: baseline to date of death from any cause up to 68 months] [Designated as safety issue: Yes]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. Time to Treatment Failure [Time Frame: baseline to stopping treatment (up to 68 months)] [Designated as safety issue: Yes]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. 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] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief Title	Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
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
Brief 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. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Breast Cancer
Intervention	Drug: 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) Other Names: LY188011 Gemzar Drug: doxorubicin 60 mg/m^2, IV, every 21 days x 4 cycles (1-4) Drug: cisplatin 70 mg/m^2, IV, every 21 days x 4 cycles (5-8) Procedure: surgery Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
Study Arm (s)	Experimental: Gemcitabine+Doxorubicin+Cisplatin+Surgery 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	65
Estimated Completion Date	April 2009
Estimated Primary Completion Date	April 2009
Eligibility Criteria	Inclusion Criteria: - 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. Exclusion Criteria: - Inflammatory breast cancer - Pregnancy and Breast-feeding - Serious concomitant disorder or infection - Previous cancer within the last 5 years or a second primary malignancy.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00191789
Other Study ID Numbers	7117
Has Data Monitoring Committee	No
Information Provided By	Eli Lilly and Company
Study Sponsor	Eli Lilly and Company
Collaborators	Not Provided
Investigators	Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST) Eli Lilly and Company
Verification Date	July 2010

Locations[ + expand ][ + ]

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, India, 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, India, 632004
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, India, 110029