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Completed

NCT Number: NCT00191789

Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

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

Doxorubicin

Drug

60 mg/m^2, IV, every 21 days x 4 cycles (1-4)

Cisplatin

Drug

70 mg/m^2, IV, every 21 days x 4 cycles (5-8)

Surgery

Procedure

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Summary of Deaths During Study

    Time frame: baseline through last cycle on study drug (eight 21-day cycles)

  2. Progression Free Survival (PFS)

    Time frame: 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.

  3. Overall Survival

    Time frame: 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.

  4. Time to Treatment Failure

    Time frame: 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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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