Clinical trial · Interventional
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
- 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 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.
Conditions
Conditions (3)
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 |
| Breast Neoplasms, Male | Breast Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Carcinoma, Ductal | Breast Ductal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Overall Tumor Response
- timeFrame
- every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
- description
- 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.
Secondary outcomes (4)
- measure
- Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
- timeFrame
- every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available