Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

NCT00191789 | Completed Phase 2 Results

• 2 other identifiers: 7117B9E-MC-S329
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)

  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.

  tumor assessment at baseline and during surgery after eight 21-day treatment cycles

Secondary Outcomes (5)

• Summary of Deaths During Study

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

• Progression Free Survival (PFS)

  baseline to measured progressive disease or death from any cause (up to 68 months)

• Overall Survival

  baseline to date of death from any cause up to 68 months

• Time to Treatment Failure

  baseline to stopping treatment (up to 68 months)

• 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

Study Arms (1)

Gemcitabine+Doxorubicin+Cisplatin+Surgery

EXPERIMENTAL

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; Drug: doxorubicin; Drug: cisplatin; Procedure: surgery

Interventions

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)

Also known as: LY188011, Gemzar

Gemcitabine+Doxorubicin+Cisplatin+Surgery

doxorubicin DRUG

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

Gemcitabine+Doxorubicin+Cisplatin+Surgery

cisplatin DRUG

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

Gemcitabine+Doxorubicin+Cisplatin+Surgery

surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Pune, Maharashtra, 411001, India

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.

Vellore, Tamil Nadu, 632004, India

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.

Delhi, 110029, India

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Doxorubicin; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2003
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 27, 2010
• Results First Posted: July 22, 2010

Record last verified: 2010-07

Locations

IN (3)