Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

Patients will receive vitamin B12 and folic acid supplementation.

It had 1 arm (groups): Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin (Folotyn) (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

This is an open label, multi-center, Phase 2 study of pralatrexate with vitamin B12 and folic acid supplementation in patients with advanced or metastatic breast cancer who have failed prior treatment(s).

The start of study treatment is defined as the initiation of pralatrexate administration.

Pralatrexate will be administered as an intravenous (IV) push over 3-5 minutes on days 1 and 15 (± 1 day at each time point) of a 4-week cycle (ie, every \[q\] 2 weeks).

Vitamin supplementation will continue throughout the study and for at least 30 days after the last administration of pralatrexate.

Who Took Part

The registry lists 22 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: HER-2 negative advanced or metastatic breast cancer. Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease. Advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated. Female 18 years of age or older. Performance status less than or equal to 2.

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: patients with only bone metastasis; patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer; patients with inflammatory breast cancer.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-03 with completion listed for 2012-04.

It ran at 14 sites in France (6), Czechia (3), Hungary (3) and United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective Response Rate (ORR).

It also tracked 3 secondary outcomes, for example Duration of Response (DOR), Overall Survival (OS) and Incidence of Adverse Events (AEs) and Laboratory Abnormalities.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.