advanced breast cancer MedDRA version: 8.0 Level: LLT Classification code 10006285
Conditions
Interventions
Trade Name: Alimta 500 mg
Product Name: Alimta 500mg
Product Code: LY231514
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Pemetrexed
CAS Number: 150399-23-8
Current Sponso
Sponsors
Eli lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Females with histologic or cytologic diagnosis of advanced breast cancer. See Protocol Attachment S098.1, American Joint Committee on Cancer Staging Criteria for Breast Cancer (Fleming et al. 1997 ). Lesions should not be amenable to surgery or radiation of curative intent. [2] Performance status of 0 to 2 on the ECOG performance status schedule. See Protocol Attachment S098.2. [3] One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment. [4] One prior chemotherapy containing taxanes as (neo)adjuvant or palliative 1st-line treatment. [5] Prior radiation therapy is allowed to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [14] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [15] Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine [16] Have received more than one line of chemotherapy in MBC. Patients having received more than one combination of A plus T. [17] Are pregnant or breast-feeding. [18] Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study. [19] Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. [20] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is = 80 ml/min. [21] Have central nervous system (CNS) metastases. [22] Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry. [23] Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone. [24] Concurrent administration of any other antitumor therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the antitumor activity, as measured by tumor response rate (proportion of patients with complete or partial response) for patients with advanced breast cancer who receive one of the two chemotherapy regimens: • Arm A: Pemetrexed (600 mg/m2, D1) plus Carboplatin (AUC 5, D1) combination therapy every 21 days • Arm B: Gemcitabine (1200 mg/m2 D1, D8) plus Vinorelbine (30 mg/m2 D1, D8) combination therapy every 21 days ;Secondary Objective: • to assess the time to event efficacy variables including: ? duration of response ? time to response ? time to progressive disease ? time to treatment failure • to characterize the quantitative and qualitative toxicities in each treatment arm in this patient population. • To assess quality of life using the EORTC questionnaires QLQ-C30 and BR-23. ;Primary end point(s): The clinical response rate and its 95% exact binomial confidence interval as described by Leemis and Trivedi (1996) will be presented for each treatment arm. The estimate of the overall best response rate will be given by Response rate = Sum of # of PRs and # of CRs observed in qualified patients/ Number of qualified patients In addition, rates including the 95% confidence intervals will be reported by treatment arms for the overall best response of CR, PR, SD, and PD, respectively. These analysis will also be done on all randomized patients. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed