Phase 2
Completed N=37
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Breast Cancer · Breast Neoplasms, Male · Carcinoma, Ductal
Source: ClinicalTrials.gov NCT00106002 ↗
Enrolled (actual)
37
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Overall Tumor Response — 1; 8; 14; 9 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Tumor Response |
1; 8; 14; 9; 3 | — |
| SECONDARY Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) |
5; 0; 4; 2; 8; 5 | — |
| SECONDARY Duration of Tumor Response |
7.3 | — |
| SECONDARY Progression-Free Survival Time |
4.1 | — |
| SECONDARY Overall Survival Time |
18.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00106002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.