Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line

Phase 2CompletedNCT00191854

Eli Lilly and Company147 enrolled

Overview

The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Breast Cancer

Interventions

gemcitabineDRUG

2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles

paclitaxelDRUG

150 mg/m2, IV, every 14 days x 8 cycles

carboplatinDRUG

Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients with histological or cytological proven diagnosis of breast cancer * Stage IV disease * Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale * Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease * Adequate organ function Exclusion Criteria: * Prior chemotherapy for metastatic disease * Previous radiation therapy is allowed but must not have included whole pelvis radiation * Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator * Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin)) * Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia

Locations (18)

Outcomes

Primary Outcomes

Best Overall Response

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.

Time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)

Secondary Outcomes

Number of Participants With a Time to Treatment Failure (TTTF) Event

TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.

Time frame: randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)

Progression Free Survival (PFS)

PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.

Time frame: baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)

Duration of Response

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Santo André, Brazil

São Paulo, Brazil

Beijing, China

Hangzhou, China

Nanjing, China

Wuhan, China

Delhi, India

Kolkata, India

Ludhiana, India

Mumbai, India

...and 8 more locations