Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499681
Status:
TERMINATED
Last Update Posted:
2012-08-10
First Post:
2007-07-10
Brief Title:
PhII Neo-Adjuvant Letrozole Lapatinib in Pts wHER2 Hormone Receptor Operable Breast CA SPORE
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A Phase II Neo-Adjuvant Study of Letrozole in Combination With Lapatinib in Post -Menopausal Patients With HER2-Positive and Hormone Receptor-Positive Operable Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I stage II or stage III breast cancer that can be removed by surgery
PURPOSE This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I stage II or stage III breast cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
To determine the pathological complete response in patients with HER2-positive and hormone receptor-positive operable stage I-III breast cancer
Secondary
To determine tumor cell apoptosis in situ as measured by TUNEL analysis of tumor sections from fresh frozen or paraffin-embedded core biopsies Parts 1 and 2
To determine whether EGFR P-EGFR P-HER2 Ser118 P-ERĪ± P-Akt and P-MAPK by IHC using fresh frozen or paraffin-embedded core biopsies predict the inhibition of proliferation in situ Ki67 andor induction of cell death TUNEL Parts 1 and 2
To determine the safety profile of neoadjuvant letrozole and lapatinib Part 2
To evaluate tumor response to treatment as measured by ultrasound Part 2
To evaluate the rate of breast conservation surgery Part 2
To determine the inhibition in cell proliferation in situ in response to letrozole and lapatinib as measured by the change in percentage of Ki67-positive tumor cells determined by IHC using tumor sections from fresh frozen or paraffin-embedded surgical material Part 2
OUTLINE This is a randomized double-blind placebo-controlled two-part study
Part 1 Patients are randomized to treatment arm
Patients receive lapatinib and letrozole once daily for 2 weeks
Patients receive letrozole and placebo once daily for 2 weeks Patients then proceed to part 2
Part 2 All patients receive lapatinib and letrozole once daily for 14 weeks Patients then undergo surgical resection of disease
Patients undergo tissue sample collection at baseline at 2 weeks and then at the time of surgery for biomarker and laboratory studies Samples are analyzed by IHC and TUNEL
Primary
To determine the pathological complete response in patients with HER2-positive and hormone receptor-positive operable stage I-III breast cancer
Secondary
To determine tumor cell apoptosis in situ as measured by TUNEL analysis of tumor sections from fresh frozen or paraffin-embedded core biopsies Parts 1 and 2
To determine whether EGFR P-EGFR P-HER2 Ser118 P-ERĪ± P-Akt and P-MAPK by IHC using fresh frozen or paraffin-embedded core biopsies predict the inhibition of proliferation in situ Ki67 andor induction of cell death TUNEL Parts 1 and 2
To determine the safety profile of neoadjuvant letrozole and lapatinib Part 2
To evaluate tumor response to treatment as measured by ultrasound Part 2
To evaluate the rate of breast conservation surgery Part 2
To determine the inhibition in cell proliferation in situ in response to letrozole and lapatinib as measured by the change in percentage of Ki67-positive tumor cells determined by IHC using tumor sections from fresh frozen or paraffin-embedded surgical material Part 2
OUTLINE This is a randomized double-blind placebo-controlled two-part study
Part 1 Patients are randomized to treatment arm
Patients receive lapatinib and letrozole once daily for 2 weeks
Patients receive letrozole and placebo once daily for 2 weeks Patients then proceed to part 2
Part 2 All patients receive lapatinib and letrozole once daily for 14 weeks Patients then undergo surgical resection of disease
Patients undergo tissue sample collection at baseline at 2 weeks and then at the time of surgery for biomarker and laboratory studies Samples are analyzed by IHC and TUNEL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK-LAP107087 | None | None | None |
| VU-VICC-BRE-0660 | None | None | None |
| VU-VICC-061102 | None | None | None |