Hot Topics Patient Information
Alberta Cancer Board
       

Study Listings (updated: Jul 16/2008)
Alberta Wide Studies Northern Program - Studies based from the Cross Cancer Institute Southern Program - Studies based from the Tom Baker Cancer Centre All Current Studies

All Current Studies

Click on the Study Number/Sponsor for more details about the study.
Study Number or Sponsor Study Title Study Purpose Centre
. A randomized phase 2 study of SU 011248 vs standard-of-care for patients with previously treated, advanced triple-receptor negative (ER, PR and HER2) breast cancer Many chemotherapy drugs give benefit in the general population of patients with advanced breast cancer, either by shrinking tumors or by delaying growth. It is not known at this time which is the best available treatment for patients with triple receptor negative disease.
The purpose of this study is to compare the disease progression-free time with SU011248 compared to treatment with standard chemotherapy. 		CCI
       
. A Multicenter, Placebo-Controlled, Double-Blind Randomized
Phase II Trial of Neoadjuvant Treatment with Single-Agent Bevacizumab or Placebo, followed by Six Cycles of Docetaxel,Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab, in Patients with Stage II or Stage III Breast Cancer
 Cancer cells are different from normal cells in many ways. One way that they are different is that they can make new blood vessels develop, bringing blood and nutrients to themselves. In this way, cancer cells can help themselves to grow faster than normal cells.

Scientists have been studying cancer cells and trying to develop new medications to stop their activities. Bevacizumab is new medication not yet approved for use in breast cancer that is thought to work by blocking the formation of new blood vessels needed for the tumor to grow and spread. In this research study, the medication bevacizumab will be studied before chemotherapy, with the chemotherapy and then again after surgery.

The main purpose of this phase 2 study is to test the safety, tolerability, and effectiveness of two different doses of the drug bevacizumab, when used before, during and after the chemotherapy medications docetaxel, doxorubicin and cyclophosphamide (or “TAC”) for women with Stage 2 or 3 breast cancer.
CCI
       
. EGF107671: A Phase II Study of Lapatinib Plus Topotecan or Lapatinib Plus Capecitabine in the Treatment of Recurrent Brain Metastases From ERB2-Positive Breast Cancer Following Cranial Radiotherapy Effective + well-tolerated therapy for brain metastases from HER2-over expressing breast cancer remains an unmet medical need. Most research studies of novel agents for brest cancer specifically exclude patients with brain metastases. The purpose of this study is to see if lapatinib combined with topotecan or lapatinib combined with capecitabine is an effective treatment for HER2 positive breast cancer with recurrent brain metastses after initial treatment with whole brain radiation. All 3 of these drugs work differently and it is hoped that one of these combinations will slow or stop the cancer from grwoing. This study is also being performed to test the safety of these drug combinations by monitoring side effects, how severe side effects may be and how often they occur. CCI
       
. For Women with Estrogen Positive Metastatic Breast Cancer Discordance of Pre-Treatment FDG-PET and FES-PET in Addition to Presence of Ki-67 and Human Epidermal Growth Factor 2 (Her-2) Overexpression will Predict for Hormone Refractory Disease When Compared to Standard Response Criteria A study to see how useful PET scans are to predicting response to hormone therapy in women with metastatic breast cancer CCI
       
. Pharmacogenetics of Exemestane The purpose of this study is to find out if genetic differences can affect how your body uses the anti-cancer medication exemestane. Other purposes of the study are to find out if these genetic differences could cause people to experience different side effects when receiving exemestane, and to find out if these differences could predict who benefits most from exemestance in the long term. CCI
       
. H6Q-MC-S035: A Double-Blind, Randomized, Phase 2 Trial of Capecitabine plus Enzastuarin versus Capecitabine plus Placebo in Patients with Metastatic or Recurrent Breast Cancer Previously Treated with an Anthracycline and a Taxane The purpose of this study is to find out whether the combination of Capecitabine and Enzastaurin slow the progression of breast cancer versus Capecitabine plus placebo (sugar tablet). Additional reasons for this study are to compare side effects between these two treastments, evaluate what the body does in response to the treatments (pharmacokinetics) and to examine the change caused by the study treatments at the cellular level (biomarkers). More research needs to be completed in order to confirm what has shown to be a promising new drug in the treatment of advanced/metastatic breast cancer. CCI
       
. A randomized Trial of Anastrazole vs Anastrazole and Fulvestrant as First Line Therapy for Post menopausal Women with Metastatic Breast Cancer To compare time to tumour progression between Anastrazole alone & Anastrazole combined with Fulvestrant ( a pure-anti-estrogen-Combinations vs single agents TBCC
       
. a Randomized, Phase III trial of Exemestane vs Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer. - to compare event-free survival between women treated with exemestane or anastrozole as adjuvant therapy,
inhibitor. 		TBCC
       
. MAC 12 TailorX: Trial Assigning Individualized Options for Treatment To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal therapy in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category (An Oncotype DX recurrence score of 11-25) TBCC
       
. MAC9 (SO307): Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer To compare disease free and overall survival in patients receiving clodronate, versus ibandronate, versus zoledronic acid as part of their adjuvant treatment for breast. TBCC
       
. AVEREL study (B020231): A randomized, open-label, 2 arm phase III study to evaluate the efficacy and safety of bevacizumab in combination with traztuzamab/docetaxel compared with traztuzamab/docetaxel alone as first line treatment for patients with HER2 positive locally recurrent or metastatic breast cancer. To determine if combining Herceptin and Bevacizumab in HER2 positive cancers will enhance anti-tumour activity. HER2 positive tumours have significantly increased levels of angiogenesis (blood vessel formation). Avastin (Bevacizumab) is an anti-angiogenesis agent TBCC
       
. Evaluation of novel serum markers for early detection and treatment monitoring of breast cancer patients.

 We are currently evaluating the possible diagnostic value of measuring the following serum parameters in patients undergoing treatment with breast cancer. These new tests include measuring circulating HER2/neu, counting circulating malignant breast cancer cells, and measuring the amount of circulating keratin in the serum. If these tests are sucessful they could provide new diagnostic tools for physicians to improve early diagnosis, and monitor breast cancer treatments. TBCC
       
. 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
       
Alberta Cancer Board Clinical Hypersensitivity to Radiotherapy: Tissue Banking and Analysis of the Underlying Molecular Mechanisms Many people receive radiation therapy as part of their recommended anti-cancer treatments. However, some people experience severe skin reactions from radiation therapy. At this time, scientists and researchers do not know how to predict who might experience skin reactions. If doctors knew which people were more sensitive, radiation treatment could be given in a different way or a different dose.
The purpose of this study is to study the tissue and blood of people who have received radiation treatment to learn more about the differences between people. 		CCI
       
Alberta Cancer Board Genotype analysis of xenobiotic metabolizing enzymes as predictors of famlial breast cancer susceptibility. TBCC
       
Alberta Cancer Board Provincial Clinical Research Program Grant Pre-operative PET Imaging in Breast Cancer Patients: Correlation with Histologic Findings of Sentinel Node Biopsies and Axillary Dissection The standard treatment for breast cancer is surgical removal of the cancer with either a lumpectomy or mastectomy, along with the removal of the lymph nodes in the armpit. These lymph nodes are routinely removed, as they provide information about whether or not cancer cells have spread and what the risk might be of further cancer cell spread to other parts of the body. However, when lymph nodes are surgically removed from the armpit there is risk of arm swelling, numbness, pain, and fluid accumulation in that arm and armpit. A new surgery called sentinel lymph node biopsy has been developed to try to decrease the chance of these side effects happening.
If the doctor knew that there were no cancer cells at all in the armpit lymph nodes, these surgeries might be unnecessary. New scans that examine the body in great detail have been developed; one of these is called a PET scan.
The purpose of this study is to find out how well PET scanning and sentinel lymph node biopsy can detect cancer cells in lymph nodes in women with breast cancer. 		CCI
       
Alberta Cancer Board, RIP Program Evaluation of the role of c-Src activation in breast cancer.

 Src is an enzyme that appears to become activated in a significant number of breast cancers. We are studying the implications of this activation for patients who have breast cancers with this change. Currently, therapies are under development to specifically target this enzyme as a possible anti-cancer treatment. TBCC
       
AVF3693g A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer This study is being offered to women who have breast cancer that has returned in the breast area or somewhere else in your body. The routine treatment recommendation would be to receive chemotherapy to try and shrink the tumor. CCI
       
Beatrice An International Multi-Centre Open-Label 2-Arm Phase III Trial of Adjuvant Bevacizumab in Triple Negative Breast Cancer To investigate the efficacy and safety of the addition of 1 year of bevacizumab to adjuvant chemotherapy for triple negative breast cancer compared to adjuvant chemotherpy alone CCI
       
Canadian Breast Cancer Foundation Evaluation of markers predictive of bone metastases in breast cancer patients. To show which patients are at risk for developing bone metastasis. TBCC
       
Canadian Breast Cancer Foundation-Alberta Northwest Territories Chapter "Canadian Breast Cancer Foundation-Alberta Research Tumor Bank (ARTB) The ARTB provides a comprehensive collection of cancer specimens and related clinical information that enables researchers to address unanswered questions concerning the prognosis and treatment of breast cancer and other cancers. The ARTB is a multi-user resource that is available to a wide range of cancer researchers in Alberta and elsewhere, and that uses and develops leading-edge tumor banking practices and promotes growth in cancer research CCI
       
CBCRA Effects of Aerobic Training on heart function and exercise capacity in women with HER2 positive breast cancer treated with Herceptin Herceptin is often prescribed as part of the treatment plan for breast cancer. Occasionally, Herceptin therapy given after or during chemotherapy may cause the heart muscle to become weakened. Currently, there are no known therapies to prevent heart muscle weakness associated with Herceptin. One strategy that may be beneficial is aerobic exercise training. Aerobic training has been shown to be a safe and feasible therapy for women undergoing chemotherapy for early-stage breast cancer. However, no study to date has evaluated if exercise training can prevent heart muscle weakness associated with Herceptin therapy.
CCI
       
Follow Up II
(OCOG) 		A randomized trial of Patient-Centered strategy to facilitate transition of breast cancer survivors' routine follow-up from specialist to primary care To determine whether family physician based routine follow-up of women with breast cancer is an acceptable alternative to the existing system of specialist based follow-up 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
       
Local Pathology Study, funded by Calgary Laboratory Services Identification of tumour markers predictive of Tamoxifen resistance in breast cancer patients.

 A retrospective study evaluating the clinical outcomes of patients treated with Tamoxifen to determine if resistance, or low probablitiy of response, can be predicted by evaluation of the molecular features of the initial tumour specimen. TBCC
       
MASTER study Mindfulness-based stress reduction, blood pressure, and acute stress reactivity in women with cancer. The purpose of this study is to investigate whether participation in the Mindfulness-Based Stress Reduction (MBSR) program will reduce various physical and emotional factors associated with stress. Physical factors include blood pressure when resting, and heart rate, blood pressure and stress hormones in saliva in response to brief stressful tasks in a laboratory. Emotional factors include perceived stress, personality, coping behavior, thought and emotional patterns, and spriitual experiences. TBCC
       
MBSR - HA study Comparison between Mindfulness-Based Stress Reduction (MBSR) and Healing Arts (HA) programs on spirituality and benefit finding in cancer outpatients The Healing Arts program explores the holistic integration of movement, music, writing and drawing as a vehicle for processing the experiences associated with a cancer diagnosis. The aim of the program is to provide cancer patients with opportunities for self-empowerment through the creative process. Class sessions consist of body awareness exercises, journal writing, drawing, and improvisational movement to music and group discussion. The MBSR program will teach mindfulness meditation, gentle yoga practices, and other coping techniques. A one-day silent meditation retreat is held partway through the program. The purpose of this study is to evaluate the effects of the Healing Arts and Mindfulness Meditation programs on spirituality and benefit-finding in particpating cancer patients. TBCC
       
MINDSET study Randomized control trial comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on psychological and biological outcomes in breast cancer patients. This study will compare three standard psychosocial interventions commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR),
2) Supportive-Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being and the amount of stress hormones in the bloodstream. The information obtained from questionnaires and saliva samples collected during this study will be used to make these comparisons. 		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
       
NSABP B-39 / RTOG 0413 A randomized phase 3 study of conventional whole breast irradiation (WBI) vs partial breast irradiation (PBI) for women with stage 0, 1 or 2 breast cancer. (link to NSABP B-39 diagram) Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. Standard therapy after breast conservation surgery (lumpectomy) is whole breast irradiation (WBI). WBI is radiation therapy given 5 days a week for five to seven weeks to the whole breast.
Partial breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed. The type of PBI used at this site is called three-dimensional conformal radiation therapy (3D-CRT). 3D-CRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells. PBI is given two times a day for 5 days. This PBI has a shorter treatment time than WBI.
The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast. We also want to learn about the good and bad effects that radiation therapy has on you and your feelings about how your breast looks after surgery and radiation therapy.
 CCI
       
OCOG ( Delta Study) Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer To compare the efficacy of decongestive lymphatic therapy to conservative lymphedema treatment with a compression garment CCI
       
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
       
Ribbon 2 A Phase III< Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer A study to determine if patients with breast cancer that has previously recurred and been treated will benefit from additional chemotherapy combined with either Bevacizumab or a placebo CCI
       
       
 
Site is HONcode compliant
  Copyright © 2000-2008 Alberta Breast Cancer Program

Last updated: Apr 29/2008