Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Eli Lilly and Company37 enrolled

Overview

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Neoplasms, Male Carcinoma, Ductal

Interventions

pemetrexedDRUG

600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have been diagnosed with either advanced or metastatic breast cancer. * Chemotherapy has not been given for advanced or metastatic breast cancer. * The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery. * Able to carry out work of a light nature (for example, light housework, office work). * Must be at least 18 years old. Exclusion Criteria: * Have received prior bone marrow or peripheral stem cell transplantation. * Have received prior chemotherapy for metastatic breast cancer. * Are currently pregnant or breast-feeding. * Have an active infection that your doctor decides will affect your safety. * Are unable to take folic acid or vitamin B12.

Locations (1)

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.

Dallas, Texas, United States

Outcomes

Primary Outcomes

Overall Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Secondary Outcomes

Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)

Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).

Time frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up

Duration of Tumor Response

Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.

Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Progression-Free Survival Time

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Overall Survival Time

Defined as the time from date of first dose to time of death due to any cause.

Time frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up

Data from ClinicalTrials.gov

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