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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to find out what effects this new drug foretinib has on this type of breast cancer, called "triple negative" breast cancer because the cancer tissue is estrogen, progesterone and HER2 receptor negative.
This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foretinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foretinib | Drug | foretinib, at a continuous oral daily dose of 60 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response and early progression rate | All patients will be assessed for response at the end of every second cycle (every 8 weeks). Response and progression will be evaluated using RECIST 1.1. | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events as a Measure of Safety and Tolerability | All patients will be assessed for toxicity at the end of every cycle (every 4 weeks). Adverse events will be graded using CTCAE V4.0. | every 4 weeks |
| Relationship between response and biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Lupichuk | Tom Baker Cancer Centre, Calgary AB | Study Chair |
| Daniel Rayson | QEII HSC - Nova Scotia Cancer Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| BCCA - Cancer Centre for the Southern Interior |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27116183 | Result | Rayson D, Lupichuk S, Potvin K, Dent S, Shenkier T, Dhesy-Thind S, Ellard SL, Prady C, Salim M, Farmer P, Allo G, Tsao MS, Allan A, Ludkovski O, Bonomi M, Tu D, Hagerman L, Goodwin R, Eisenhauer E, Bradbury P. Canadian Cancer Trials Group IND197: a phase II study of foretinib in patients with estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2-negative recurrent or metastatic breast cancer. Breast Cancer Res Treat. 2016 May;157(1):109-16. doi: 10.1007/s10549-016-3812-1. Epub 2016 Apr 26. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C544831 | GSK 1363089 |
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Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.
| 2 years (end of study) |
| Biomarkers in Tumour cells | Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0. | 2 years (end of study) |
| Kelowna |
| British Columbia |
| V1Y 5L3 |
| Canada |
| BCCA - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Ottawa Health Research Institute - General Division | Ottawa | Ontario | K1H 8L6 | Canada |
| Hopital Charles LeMoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| D017437 |
| Skin and Connective Tissue Diseases |