Clinical trial NCT00191789: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
timeFrame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles
Secondary outcomes:
measure: Summary of Deaths During Study
timeFrame: baseline through last cycle on study drug (eight 21-day cycles)
measure: Progression Free Survival (PFS)
timeFrame: baseline to measured progressive disease or death from any cause (up to 68 months)
measure: Overall Survival
timeFrame: baseline to date of death from any cause up to 68 months
measure: Time to Treatment Failure
timeFrame: baseline to stopping treatment (up to 68 months)
measure: Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
timeFrame: baseline, after eight 21-day cycles of study drug
Other outcomes:
Locations:
city: Pune
country: India
facility: 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.
state: Maharashtra
city: Vellore
country: India
facility: 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.
state: Tamil Nadu
city: Delhi
country: India
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST)
role: STUDY_DIRECTOR
References: