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There are many reasons why a clinical trial is performed. These include questions relating to improving the quality of life for patients whilst on treatment, the impact of a cancer diagnosis on patients and family members, understanding the biological behaviour of cancer so we can better eliminate it; and most commonly to assess new treatments which improve the cure rate and cancer control for an individual.
At BCRC-WA, our dedicated Breast Clinical Trials Unit (BCTU) performs many clinical trials including those designed to:
Considering the stage (early or advanced) of the cancer and testing for tumour cell characteristics allows doctors to “tailor” cancer treatment to better suit each patient. Many people think that clinical trials all involve a placebo and that patients may not be receiving any active treatment at all. In fact, very few of our clinical trials use placebo and those that do use the placebo to compare it with a new drug given in addition to an approved or current treatment. In this way, all patients receive the current best care for them as a minimum.
Early Breast Cancer
|Short Name||Full title||HER 2||HR||Treatment Delivery||Placebo?||Notes|
|GLORIA||The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI 822)/OBI 821 in the Adjuvant Treatment of Patients with High Risk, Early- Stage Globo H-Positive Triple Negative Breast Cancer||Neg||Neg||Subcutaneous injection||No||All patients will receive Standard of Care with or without study drug. You will know whether you are receiving study drug or not.|
|DESTINY||A phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (t-dxd) versus trastuzumab emtansine (t-dm1) in subjects with high-risk her2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy.
(t-dxd vs. t-dm1 in high-risk her2-positive patients with residual invasive breast cancer following neoadjuvant therapy)
|Positive||Either||Intravenous||No||Patients will receive either T-DXd or T-DM1|
Locally Advanced or Metastatic Breast Cancer
|Short Name||Full title||Her 2||HR||Treatment Delivery||Placebo?||Notes|
|SILVERBACK||A Phase 1/1b, open-label, dose escalation and expansion study of SBT6050 in subjects with advanced solid tumors expressing Her2||Positive||Either||Subcutaneous injection||No||All patients will receive SBT6050|
|EPIK||A Phase III, multicenter, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation (H12301)||Negative||Negative||intravenous||Yes||All patients will receive nab-paclitaxel, an approved treatment in this setting, with oral alpelisib or alpelisib plus placebo. Patients’ tumour tissue is first tested at a central study laboratory for specific cancer cell characteristics. Tissue is sent from previous biopsy or surgery if possible, or new biopsy if required.|
|EMBER||EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers||Either||Pos||Oral
(IV trastuzumab if applicable)
|No||In Phase 1a part of study, all patients receive study drug alone.
In Phase 1b, there are three arms to the study. All participants will receive study drug with or without approved oral drugs or IV trastuzumab as applicable. You will know what treatment you are receiving.
|TTAC 2||A Phase II, Open-Label, Multicenter Study of Olinvacimab in Combination with Pembrolizumab in Patients with Metastatic Triple-Negative Breast Cancer||Negative||Negative||Intravenous||No||All participants will receive both olinvacimab and pembrolizumab|
|Keynote B49||A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer||Neg||Pos||Intravenous +/- oral||Yes||All participants will receive one chemotherapy agent (investigator’s choice of liposomal doxorubicin, capecitabine, paclitaxel or nab-paclitaxel) in combination with blinded pembrolizumab or placebo|
|ACE Breast 03||A Global, Phase 2 Study of ARX788 in HER2-Positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory toT-DM1, and/or T-DXd, and/or Tucatinib-Containing Regimens||Pos||Either||Intravenous||No||All participants will receive study drug ARX788|
|Olema OP-1250-002||A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer||Neg||Pos||oral||no||All subjects will receive OP-1250 and Palbociclib|
|“in addition to”. This term is used to describe treatments given to add to the effectiveness of other treatments. Usually used in the Early Breast Cancer setting to describe intravenous drug therapy, oral endocrine treatment, or radiotherapy given after surgery.|
|Double-blind||Neither the patient nor the trial staff (including doctor) know whether the patient is receiving the investigational product.|
|Endocrine therapy (aka Hormonal therapy)||Treatment used to block the effects of certain hormones in the body. See ER/PR below|
(aka Hormone Receptor positive/negative)
|ER refers to Oestrogen receptor, while PR refers to Progesterone receptor. Oestrogen and Progesterone are naturally occurring hormones. Receptors for these hormones may be present on breast cancer cells. These cells would then be called ER or PR positive.|
|HER2||HER2 is a protein on the outside of some breast cancer cells. It promotes cell growth. Breast cancer cells with higher than normal levels of Her2 are called HER2-positive, those with lower levels are called HER2-negative.|
|Induction treatment||First line or initial therapy given for breast cancer|
|IV||Intravenous. A therapy given directly into a vein|
|Locally Advanced||Breast cancer which has not spread to distant parts of the body but is of a large size or has spread to several lymph nodes in the axilla (armpit)|
|Metastatic||Cancer which has spread to other parts of the body outside of the breast and axilla (armpit)|
|Monotherapy||Treatment with a single medication rather than a combination|
|Neoadjuvant||Treatment given in the early breast cancer setting before surgery|
|Open Label||The patient and the clinical trial staff, including the doctor, know which treatment the patient will receive|
|Oral||Taken by mouth|
|Phase 1||A study to determine best dose and identify side effects of a new drug. Usually given in a small group of participants who have already received several drug therapies for their cancer. Very close monitoring of participants.|
|Phase 2||Once safety has been evaluated in Phase 1, a Phase 2 study involves evaluation of efficacy (whether the drug works as intended) in a larger group of participants (several hundred). Safety and side effects are still closely monitored.|
|Phase 3||A study to compare how effective a new treatment is compared with current best treatments, or other similar new treatments, in a much larger group of participants (often several thousand). Safety and side effects still closely monitored.|
|Pre-operative||Treatment given for breast cancer setting before surgery|
|Randomised||Assigned to a treatment in a random way, like tossing a coin. In clinical trials, this is usually done through a de-identified and centralized database|
|SOC – Standard of Care||The best treatment currently available in this setting|
|SC (subcutaneous)||Sometimes also written as “subcut”. An injection given into the tissue layer between the skin and the muscle. Usually the abdomen, upper arm or thigh.|
|TPC – Treatment of Physician’s Choice||Treatment decided by the treating oncologist and is regarded as an appropriate and effective option for an individual patient at that timepoint in their breast cancer treatment journey|
|Triple Negative||HER2 negative and negative for both hormone receptors (ER and PR)|