Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00191789
- Lead Sponsor
- Eli Lilly and Company
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
- 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.
- Inflammatory breast cancer
- Pregnancy and Breast-feeding
- Serious concomitant disorder or infection
- Previous cancer within the last 5 years or a second primary malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine+Doxorubicin+Cisplatin+Surgery 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. Gemcitabine+Doxorubicin+Cisplatin+Surgery gemcitabine 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. Gemcitabine+Doxorubicin+Cisplatin+Surgery cisplatin 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. Gemcitabine+Doxorubicin+Cisplatin+Surgery doxorubicin 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.
- Primary Outcome Measures
Name Time Method Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival baseline to date of death from any cause up to 68 months 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 baseline to stopping treatment (up to 68 months) 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.
Summary of Deaths During Study baseline through last cycle on study drug (eight 21-day cycles) Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery baseline, after eight 21-day cycles of study drug 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.
Progression Free Survival (PFS) baseline to measured progressive disease or death from any cause (up to 68 months) 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.
Trial Locations
- Locations (1)
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