RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells. PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
OBJECTIVES: Primary * To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS) Secondary * To correlate CYP2D6 score (0 vs 1 vs 2) and PFS * To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months. * To correlate endoxifen concentration with response * To correlate CYP2D6 with response * To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes OUTLINE: This is a multicenter study. Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Blood, plasma, and tissue samples are collected periodically for laboratory studies. After completion of study therapy, patients are followed up every 3-6 months for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
PO
Progression-free Survival by CYP2D6 Status in 2 Categories
Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Assessed every 3 months for 2 years, then every 6 months up to 5 years
Progression-free Survival by CYP2D6 Status in 3 Categories
Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Assessed every 3 months for 2 years, then every 6 months up to 5 years
Proportion of Patients Progression-free at 6 Months
Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States
Mercy Cancer Center at Mercy Medical Center
Merced, California, United States
Camino Medical Group - Treatment Center
Mountain View, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
...and 284 more locations
Time frame: Assessed every 3 months for 6 months
Proportion of Patients With Response
Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response. Either complete response (CR) or partial response (PR) is considered as response. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Assessed every 3 months for 2 years, then every 6 months up to 5 years
Endoxifen Concentration by Response
Endoxifen (ng/ml) was assessed at cycle 3. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response. Either complete response (CR) or partial response (PR) is considered as response. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Endoxifen was assessed at cycle 3; response was assessed every 3 months for 2 years, then every 6 months up to 5 years
Progression-free Survival From 3 Months Post Registration
This is a landmark progression-free survival analysis at 3 months post registration. Only patients who were progression-free and alive at 3 months were included. Progression-free survival in this analysis is defined as the time from 3 months post registration to progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Assessed every 3 months for 2 years, then every 6 months up to 5 years