Females with histologically confirmed diagnosis of primary early breast cancer, with a tumor size = 2 cm, of Stages T2-T4/N0-2/, as confirmed by incisional or core biopsy M0 will be treated with chemotherapy prior to surgery..
Conditions
Interventions
Product Name: Pemetrexed
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
Co
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Females, having a histologically confirmed diagnosis of primary early breast cancer, with a tumor size = 2 cm, of Stages T2-T4/N0-2/, as confirmed by incisional or core biopsy M0. - Have no inflammatory and no exulcerating breast cancer. - Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. - Have not received any previous anti-tumor therapy for breast cancer. - Have at least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria (at least 20 mm when measured by conventional techniques, i.e., mammography or magnetic resonance imaging (MRI)). - Are at least 18 years but no more than 70 years of age. - Have an estimated life expectancy of at least 6 months. - Must have adequate organ function that includes the following indices: Bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 X 10E9/L, platelet count =100 X 10E9/L, and hemoglobin =9 g/dL. Hepatic: bilirubin 55%, as measured by nuclear medicine or echocardiogram. - Must be compliant and have geographic proximity that allows adequate follow-up. - Must have signed informed consent. - Females of child-bearing potential: Must use a medically approved contraceptive regimen during and for 6 months after treatment; must have a negative serum pregnancy test and must not be lactating. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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. - Have received prior anthracyclines as part of prior anticancer therapy - Receive any other concurrent antitumor therapy. - Have a second primary malignancy, except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. - Have a serious concomitant systemic disorder (eg, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study, or have any other disease that could be worsened by chemotherapy or other potential support therapies. - Have a history of auricular-ventricular arrhythmias and/or congestive heart failure, even where it is under medical control, or active second or third degree cardiac block, have a history of myocardial infarction within the last 6 months prior to recruitment, or have non-controlled or malignant high arterial blood pressure. - Have a history of hypersensitivity to the drugs under study or earlier allergic reactions to the compounds containing cremophor, such as teniposide, cyclosporin or Vitamin K. - Have pre-existing sensorial or motor neuropathy > grade 1. - Are unable or unwilling to take dexamethasone, folic acid, Vitamin B12, or dexamethasone supplementation. - Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To assess the clinical response rates after the first and second sequence of chemotherapy in both treatment arms in this patient population. - To assess the rate of histologically negative axillary lymph node status in both treatment arms. - To assess disease-free survival in both treatment arms. - To characterize the quantitative and qualitative toxicities of both treatment arms in this patient population. ;Main Objective: The primary objective of the study is to assess the antitumor activity, as measured by the pathologic complete response (pCR) rate in the breast, of neoadjuvant treatment with two different sequential treatment regimens (AP->Doc, AC->Doc) in female patients with early breast cancer (T2-T4/N0-N2/M0).;Primary end point(s): The primary objective of the study is to assess the antitumor activity, as measured by the pathologic complete response rate in the breast, of neoadjuvant treatment with two different sequential treatment regimens in female patients with early breast cancer (T2-T4/N0-N2/M0). | — |
Countries
Germany, Italy, Spain
Outcome results
None listed