Advanced breast cancer
Conditions
Interventions
Product Name: ALIMTA
Product Code: LY231514
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514 disodium
Conce
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Histologic or cytologic diagnosis of breast cancer with locally advanced or metastatic disease that is not amenable to local treatment (for example, surgery or radiotherapy). [2] Patients must be chemonaive or have received only neoadjuvant and/or adjuvant chemotherapy. [3] At least one unidimensionally measurable lesion, meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000, see Protocol Attachment JMGV.3) criteria (at least 10 mm in longest diameter by spiral computed tomography [(CT]) scan, or at least 20 mm by standard techniques). Ultrasounds and positron emission tomography (PET) scans cannot be used. [4] No chemotherapy is allowed within 4 weeks before enrollment in the study; prior therapy or concomitant therapy with bisphosphonates is allowed, per Section 5.7.7 of this document. [5] Prior endocrine therapy is allowed but must be stopped at the time of enrollment, with the exception of luteinizing hormone-releasing hormone (LH-RH) analogues. [6] Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale (Oken et al. 1982, see Protocol Attachment JMGV.1). [7] 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] Prior chemotherapy for advanced breast cancer. [15] Prior treatment with any anthracycline- or anthracenedione-containing regimen. [16] Serious concomitant systemic disorders, including active infection, that would compromise the safety of the patient or compromise the patient’s ability to tolerate and/or complete the study, at the discretion of the investigator. [17] Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of enrollment. [18] Documented brain metastases (unless the patient has completed successful local therapy for central nervous system [CNS] metastases and has not taken corticosteroids for at least 4 weeks before enrollment). Brain imaging is not required in asymptomatic patients, but is required in symptomatic patients to rule out brain metastases. [19] Second primary malignancy (except adequately treated in situ carcinoma of the cervix, adequately treated nonmelanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence). [20] Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) or clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, hypertensive cardiomyopathy, or left ventricular ejection fraction [LVEF] to below the lower limit of normal or an absolute LVEF £45%). [21] Pregnancy and/or breast-feeding. [22] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA (5 days prior for long-acting agents such as piroxicam). [23] Persons who have previously completed or withdrawn from this study or any other study investigating ALIMTA. [24] Inability or unwillingness to take folic acid, vitamin B12, or dexamethasone supplementation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of ALIMTA plus doxorubicin, as measured by overall tumor response rate, in patients with advanced breast cancer who have not been previously treated with an anthracycline-containing regimen.;Secondary Objective: to assess time-to-event efficacy variables for ALIMTA plus doxorubicin in this patient population, including: -time to progressive disease (TtPD) -progression-free survival (PFS) -overall survival (OS) to characterize the quantitative and qualitative laboratory and nonlaboratory data of ALIMTA plus doxorubicin in this patient population. ;Primary end point(s): Overall tumor response rate, based on the patient’s best response. Tumor response will be assessed using the RECIST criteria. | — |
Countries
Spain
Outcome results
None listed