Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer
The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.
Cancer of the Breast
Human Mammary Carcinoma
Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer|
- Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.
- Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]One patient has a PR as response and duration of response was provided for that patient.
- Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate. ] [ Designated as safety issue: No ]Number of days from first dose of pralatrexate to death.
- Incidence of Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal). ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Drug: Pralatrexate Injection
- Vitamin B9
Intravenous (IV) push administration over 3-5 minutes.
Initial dose: 190 mg/m2
Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.
Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.
1 mg intramuscular injection
Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate.
1.0-1.25 mg orally
Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118624
|United States, Oregon|
|Providence Cancer Center|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Fakultní nemocnice Olomouc|
|Olomouc, Czech Republic, 775 20|
|Pardubice, Czech Republic, 532 03|
|Fakultní nemocnice Královské Vinohrady - FNKV|
|Praha, Czech Republic, 100 34|
|Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)|
|Montpellier, Cedex 5, France, 34298|
|Centre Régional de Lutte Contre le Cancer Alexis Vautrin|
|Vandoeuvre, les Nancy Cedex, France, 54511|
|Centre Georges François Leclerc|
|Dijon Cedex, France, 21079|
|Centre Léon Bérard|
|Lyon Cedex, France, 69373|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|Reims Cedex 09, France, 51056|
|University of Debrecen Medical and Health Science Center|
|Debrecen, Hajdú-Bihar, Hungary, 4032|
|Semmelweis University Budapest|
|Budapest, Hungary, H-1082|
|National Health Centre of Hungary|
|Budapest, Hungary, H-1145|
|Study Director:||Garry Weems, PharmD||Spectrum Pharmaceuticals, Inc|