Status:

COMPLETED

Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

Lead Sponsor:

Eli Lilly and Company

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 high...

Eligibility Criteria

Inclusion

  • 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

  • Inflammatory breast cancer
  • Pregnancy and Breast-feeding
  • Serious concomitant disorder or infection
  • Previous cancer within the last 5 years or a second primary malignancy.

Key Trial Info

Start Date :

February 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT00191789

Start Date

February 1 2003

End Date

April 1 2009

Last Update

July 27 2010

Active Locations (3)

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Page 1 of 1 (3 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.

Pune, Maharashtra, India, 411001

2

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

3

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

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