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Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191789
First received: September 12, 2005
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  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 Intervention Phase
Breast Cancer
 Drug: gemcitabine
Drug: doxorubicin
Drug: cisplatin
Procedure: surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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.


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.


Enrollment: 65
Study Start Date: February 2003
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191789

Locations
India
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
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191789     History of Changes
Other Study ID Numbers: 7117, B9E-MC-S329
Study First Received: September 12, 2005
Results First Received: April 29, 2010
Last Updated: July 21, 2010
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013