Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-03-03 @ 12:39 AM
Study NCT ID:
NCT02668666
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2016-01-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
Sponsor:
Oana Danciu, MD
Organization:
Study Overview
Official Title:
A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.
Detailed Description:
OUTLINE: This is a multi-center trial.
INVESTIGATIONAL TREATMENT:
* Palbociclib 125 mg will be administered orally once daily on days 1-21 (D1-D21) of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
* Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Palbociclib should be taken with food in combination with tamoxifen. Subjects should take their dose at approximately the same time each day.
It is encouraged, but not mandatory, that premenopausal subjects will also receive treatment with goserelin or equivalent (e.g., Lupron) given as an injectable subcutaneous implant on D1 of every 28 days cycle or every 3 months.
Disease assessments will be performed at the completion of every 2 cycles.
Treatment will continue until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for a total of 24 months after discontinuation of study drug.
To demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration for protocol therapy:
Hematological (must meet ALL of the following criteria):
* Absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100 × 10 9/L
Renal (must meet ONE of the following criteria):
* Serum creatinine ≤ 1.5 × ULN
* Serum creatinine \> 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min
Hepatic (must meet ALL of the following criteria):
* Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
* Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
* Total serum bilirubin ≤ 1.5 × ULN
INVESTIGATIONAL TREATMENT:
* Palbociclib 125 mg will be administered orally once daily on days 1-21 (D1-D21) of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
* Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Palbociclib should be taken with food in combination with tamoxifen. Subjects should take their dose at approximately the same time each day.
It is encouraged, but not mandatory, that premenopausal subjects will also receive treatment with goserelin or equivalent (e.g., Lupron) given as an injectable subcutaneous implant on D1 of every 28 days cycle or every 3 months.
Disease assessments will be performed at the completion of every 2 cycles.
Treatment will continue until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for a total of 24 months after discontinuation of study drug.
To demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration for protocol therapy:
Hematological (must meet ALL of the following criteria):
* Absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100 × 10 9/L
Renal (must meet ONE of the following criteria):
* Serum creatinine ≤ 1.5 × ULN
* Serum creatinine \> 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min
Hepatic (must meet ALL of the following criteria):
* Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
* Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
* Total serum bilirubin ≤ 1.5 × ULN
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: