Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 12:46 AM
Study NCT ID:
NCT01013506
Status:
WITHDRAWN
Last Update Posted:
2013-05-23
First Post:
2009-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2, Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-sensitive Metastatic Breast Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) With or Without Erlotinib (Tarceva, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer.
Status:
WITHDRAWN
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was abandoned before opening to accrual. Replaced by another study.
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 +/- goserelin (the latter for pre-menopausal women only) may fight breast cancer by lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy and OSI-906 are more effective when given with or without erlotinib hydrochloride in treating hormone-sensitive metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving hormone therapy together with OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients with metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving hormone therapy together with OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients with metastatic breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* To determine the antitumor activity of letrozole +/- goserelin (the latter for pre-menopausal women only) in combination with IGF-1R inhibitor OSI-906 with or without erlotinib hydrochloride, measured by time to progression, in patients with hormone-sensitive metastatic breast cancer.
Secondary
* To determine the safety of these regimens in these patients.
* To determine the response rate in patients treated with these regimens.
* To measure circulating C-peptide, IGF-1, and IGFBP-3 levels in patients treated with these regimens.
* To correlate the expression of IGF-IR, EGFR, HER2, Y1316 and Y1131 pIGF-1R, PTEN, S473 pAkt, pMAPK, S118 (MAPK site), and S167 (Akt and S6 site) pER in formalin-fixed paraffin blocks (FFPB) with clinical outcome and luminal A vs. luminal B subtypes of breast cancer.
* To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and luminal A vs. luminal B subtypes of breast cancer
OUTLINE: This is a multicenter study. Stratification will be based on previous exposure to endocrine therapy: (Arm I) no previous endocrine therapy or have completed adjuvant therapy \> 6 months prior to study enrollment; (Arm II) patients that had previous endocrine therapy in the metastatic setting or had metastatic recurrence within 6 months of adjuvant endocrine therapy.
* Arm I: Patients receive oral letrozole once daily on days 1-28 +/- subcutaneous goserelin\* on day 1 and oral IGF-1R inhibitor OSI-906 twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral letrozole +/- subcutaneous goserelin\* and IGF-1R inhibitor OSI-906 as in arm I. Patients also receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*Goserelin will only be given to premenopausal patients.
Tumor tissue samples from original diagnosis or from fresh biopsy tissue are collected for biomarker analysis and other studies.
After completion of study therapy, patients are followed periodically.
Primary
* To determine the antitumor activity of letrozole +/- goserelin (the latter for pre-menopausal women only) in combination with IGF-1R inhibitor OSI-906 with or without erlotinib hydrochloride, measured by time to progression, in patients with hormone-sensitive metastatic breast cancer.
Secondary
* To determine the safety of these regimens in these patients.
* To determine the response rate in patients treated with these regimens.
* To measure circulating C-peptide, IGF-1, and IGFBP-3 levels in patients treated with these regimens.
* To correlate the expression of IGF-IR, EGFR, HER2, Y1316 and Y1131 pIGF-1R, PTEN, S473 pAkt, pMAPK, S118 (MAPK site), and S167 (Akt and S6 site) pER in formalin-fixed paraffin blocks (FFPB) with clinical outcome and luminal A vs. luminal B subtypes of breast cancer.
* To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and luminal A vs. luminal B subtypes of breast cancer
OUTLINE: This is a multicenter study. Stratification will be based on previous exposure to endocrine therapy: (Arm I) no previous endocrine therapy or have completed adjuvant therapy \> 6 months prior to study enrollment; (Arm II) patients that had previous endocrine therapy in the metastatic setting or had metastatic recurrence within 6 months of adjuvant endocrine therapy.
* Arm I: Patients receive oral letrozole once daily on days 1-28 +/- subcutaneous goserelin\* on day 1 and oral IGF-1R inhibitor OSI-906 twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral letrozole +/- subcutaneous goserelin\* and IGF-1R inhibitor OSI-906 as in arm I. Patients also receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*Goserelin will only be given to premenopausal patients.
Tumor tissue samples from original diagnosis or from fresh biopsy tissue are collected for biomarker analysis and other studies.
After completion of study therapy, patients are followed periodically.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-BRE-0977 | None | None | View |