Clinical trial · Interventional
Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer
Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer
NCT00065533CI-TRIAL-00000764completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess tumor response.
Secondary outcomes (3)
- measure
- To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.
- measure
- To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival.
- measure
- To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be at least 18 years of old. * Have been diagnosed with breast cancer * At least one year disease-free interval after initial treatment. * Have pre-study laboratory tests that are within the requirements of this study. * Be able to visit the doctor's office weekly during the treatment period. Exclusion Criteria: * To be pregnant or breastfeeding. * To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy. * To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment. * To have another illness that your doctor thinks would make you unable to participate. * To be unable or not willing to take folic acid and vitamin B12.
References
Publications (0)
Data not yet available
No reference posted for this study.