Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Mitogens

Taxane

Trastuzumab

Antimetabolites

Antineoplastic Agents, Immunological

Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).

Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)

Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).

Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).

Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).

Herceptin

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Among tumor responders, the duration of tumor response is measured from the date of response (complete response \[CR\] or partial response \[PR\]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.

If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.

Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.

Eli Lilly and Company

Chief Medical Officer

Adverse events are provided for all patients who received at least one dose of study drug. Adverse events represent all grades (I-IV).

Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.

Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).

HER2+

Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).

Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).

HER2- (Taxane-)

Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).

Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).

HER2- (Taxane+)

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

0 - Fully Active

1 - Ambulatory, Restricted Strenuous Activity

2 - Ambulatory, No Work Activities

Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Eastern Cooperative Oncology Group Performance Status

Caucasian

Black

Hispanic

Other

Race/Ethnicity

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Not Evaluable (NE)

Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy.

Overall Tumor Response

Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+).

Duration of Response

Number of patients who received at least one dose of study drug.

Number of Patients Who Experienced Alopecia

Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+).

Time to Disease Progression (TTP)

1 Year Overall Survival

2 Year Overall Survival

Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+).

Spots Global Cancer Trial Database for A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

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