ABCP - Tom Baker Cancer Centre Studies

Study Number or Sponsor

Study Title

Study Purpose

Centre

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

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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

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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

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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

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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

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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

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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

Genotype analysis of xenobiotic metabolizing enzymes as predictors of famlial breast cancer susceptibility.

TBCC

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

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

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

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