Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00072865

Enrollment

Registered

2003-11-13

Start date

2003-06-30

Completion date

2005-09-30

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neoplasm Metastasis

Brief summary

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Interventions

DRUGPemetrexed

DRUGCarboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer * No prior chemotherapy for locally advanced or metastatic breast disease. * Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment. * Adequate bone marrow, liver and kidney function * RECIST criteria for disease status

Exclusion criteria

* Prior treatment with pemetrexed * Pregnant or breast feeding * Brain Metastasis * unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Design outcomes

Primary

Measure	Time frame
antitumor activity	—

Secondary

Measure	Time frame
duration of response;time to progressive disease;time to treatment failure	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026