Alberta Wide Studies
These studies are administered out of both the Cross
Cancer Institute and the Tom Baker Cancer Centre. Click
on the Study Number/Sponsor for more details about the
study.
|
| Study
Number or Sponsor |
Study
Title |
Study
Purpose |
Centre |
| . |
AMG706: A randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG706 in Combination with Paclitaxel or Open-Label Bevacizumab in Combination with Paclitaxel, as First Line Theray in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer. |
To determine if treatment with paclitaxel and AMG706 is superior to paclitaxel plus AMG 706 placebo in patients with HER2 negative locally recurrent or metastatic breast cancer. This is a three armed study. Arm A (paclitaxel plus AMG 706 placebo), Arm B (paclitaxel plus AMG 706), Arm C (paclitaxel plus bevacizumab. |
CCI & TBCC |
International Breast Cancer Study Group (IBCSG)24-02
National Cancer Institute of Canada (NCIC) |
A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT) |
Treatment with hormones has been shown to help prevent breast cancers from coming back after they have been removed by surgery if the breast cancer has hormone receptors. The hormone generally used is tamoxifen, and it is usually given for five years. It has also been shown that suppressing (shutting down) the ovaries (which stops them from making hormones such as estrogen) helps prevent breast cancers from coming back in women who are premenopausal (women whose ovaries are still making hormones).
This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition the side effects of these different treatments will be studied. |
CCI & TBCC |
International Breast Cancer Study Group (IBCSG)25-02
National Cancer Institute of Canada (NCIC)
|
A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (TEXT) |
The current standard of care for pre-menopausal women who develop breast cancer confined to the breast and lymph nodes, is either chemotherapy followed by 5 years of tamoxifen or in some cases, no chemotherapy and 5 years of tamoxifen. Some previous studies have suggested that women who become amenorrheic (stop having menstrual periods because their ovarian function is suppressed) secondary to chemotherapy and/or tamoxifen may have a better outcome than women who do not become amenorrheic. When ovarian function is suppressed, estrogen levels in the blood decrease significantly. In pre-menopausal women most of the estrogen in the body is produced by the ovaries. In post-menopausal women or women receiving injections to suppress their ovarian function, the main source of estrogen is produced by an enzyme in the body called aromatase. Estrogen can directly stimulate breast cancer cells which express hormone receptors to grow and divide.
Tamoxifen acts by blocking the interaction of estrogen with the hormone receptor. It may also directly kill cancer cells. A newer hormonal agent called exemestane inactivates the aromatase enzyme, thus further decreasing circulating estrogen. Triptorelin is a hormone injection given monthly that suppresses ovarian function.
This study will compare the effects (good and bad) of exemestane given for 5 years, versus tamoxifen given for 5 years. Both study arms will receive monthly injections of triptorelin to suppress ovarian function for 5 years. The study drugs, triptorelin and exemestane, have not been approved by Health Canada for the treatment of early stage breast cancer.
|
CCI & TBCC |
| NSABP B-36 |
A Clinical Trial of Adjuvant Therapy Comparing six Cycles of 5-Fluoruracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC)in Patients with Node-negative Breast Cancer.
(link to NSABP B-36 diagram)
|
This study is being done to find out if 6 treatments of one combination of chemotherapy drugs (5-Fluoruracil, Epirubicin and Cyclophosphamide (FEC) is any better than four cycles of Adriamycin and Cyclophosphamide (AC)in treating node-negative breast cancer. FEC chemotherapy has been studied in women with breast cancer and positive lymph nodes. FEC has not been evaluated for women with breast cancer and negative lymph nodes. |
CCI & TBCC |
| NSABP B-37 |
A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer
(link to NSABP B-37 diagram) |
You are being asked to take part in this study because your doctor has diagnosed the return of breast cancer in your operated breast, the surgical scar, the chest wall, or the regional lymph nodes. (This is referred to as loco-regional recurrence). Standard treatment for this type of recurrence includes surgery and may include radiation therapy and hormonal therapy.
This study is being done because we do not know if adding chemotherapy to the standard treatment is better or not.
This study will help us estimate:
• how well chemotherapy works to keep breast cancer from coming back;
• how much chemotherapy can decrease the risk of dying from breast cancer;
• how chemotherapy might affect quality of life.
|
CCI & TBCC |
RAPID
(OCOG) |
A randomized trial comparing whole Breast radiation to Accelerated partial breast radiation in women with DCIS or Invasive node-negative breast cancer who have undergone breast conserving surgery |
To determine if accelerated partial breast RT (bid X 5-8 days) is as effective as whole breast RT X 16-20 fractions in controlling local recurrence |
CCI & TBCC |
