Clinical Trials Update
Hello members, Our BCNA Senior Policy Officer has provided the below information regarding clinical trials that may be of interest to our members. These are also being shared in our Health Professionals Network News and the Metastatic Advisory Group (I shall post in the mets private group re EMBRACE Phase II trial). Nivolumab neoadjuvant/adjuvant clinical trial The CA209-7FL neoadjuvant/adjuvant breast cancer trial continues to be open to recruitment, running in South Australia, New South Wales and Victoria for patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer. Bristol Myers Squibb will be implementing a digital advertising campaign expected to launch in October/November 2021. This will target both health professionals and patients. More information on the trial can be found here. EMBRACE Phase II Olaparib clinical trial EMBRACE is a Phase II clinical trial of the PARP inhibitor, Olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2. Patients with metastatic triple negative breast cancer (TNBC) or relapsed platinum-sensitive high grade serous ovarian cancer (HGSOC) after first line/adjuvant therapy who have an eligible tumour molecular analysis result are suitable for the trial. There are 11 sites open in Australia in NSW, QLD, VIC, SA and WA. More information on the trial can be found here or by emailing embrace.study@sydney.edu.au We encourage members to talk with their treatment team in the first instance about any clinical trials.
Q&A – TRIPLE NEGATIVE BREAST CANCER on Tuesday 24th October from 4:30-6pm (AEDT).
Register for the Q&A on Triple Negative Breast Cancer (Submit a question.) https://www.breastcancertrials.org.au/news/qa-events/qa-triple-negative-breast-cancer/ Triple negative breast cancer accounts for approximately 15% of all breast cancers. As the name suggests, triple negative breast cancer does not have any of the three receptors that are commonly found on breast cancer cells – oestrogen, progesterone and HER2 receptors. Anyone can be diagnosed with triple negative breast cancer but it occurs more often in younger patients who are pre-menopausal or under 50 years of age. People with a BRCA1 gene mutation also have a higher risk of this type of breast cancer. Triple negative breast cancer is a more aggressive type of tumour, with a faster growth rate, a higher risk of spreading to other parts of the body (metastasis) and of recurrence either in the breast or elsewhere. Because it does not have any of the more common receptors that can be targeted by medications, such as hormone and HER2-blocking drugs, it has fewer treatment options available. Standard treatment of early stage triple negative breast cancer typically includes chemotherapy, surgery and in many cases a course of radiotherapy. Often chemotherapy treatment is given prior to breast surgery (neoadjuvant chemotherapy), as it can effectively reduce the size of the breast cancer while providing useful information about the effectiveness of the treatment being given. Breast Cancer Trials has been researching new and better treatments for triple negative breast cancer. The CHARIOT clinical trial examined the addition of dual immunotherapy to standard chemotherapy and showed promising results in patients with treatment resistant, early-stage triple negative breast cancer. The Neo-N clinical trial is investigating whether using an immunotherapy drug together with chemotherapy, is safe and effective in treating breast cancer before surgery. Results of this study are expected later this year. Join our panel of experts as we explore triple negative breast cancer. We’ll hear firsthand from women who have a history of this type of cancer, and from world-leading researchers on the latest in research and clinical trials to improve treatments and patient outcomesDr Liz O'Riordan talks about her surgeries & aftermath - A UK Breast Surgeon with Breast Cancer
Dr Liz O'Riordan was diagnosed with breast cancer some years after qualifying as a breast cancer surgeon & realised that whilst she knew some of the physical effects of Breast Cancer surgery - she really was not prepared for the psychological (and indeed actual physical limitations) that she experienced, once she'd had her own surgery, chemo, rads etc - she also suffered from extreme cording that restricted her arm movement. Eventually, after a recurrence and more surgery, it prevented her from continuing as a Breast Surgeon. This is a more recent write up : https://www.nzherald.co.nz/lifestyle/dr-liz-oriordan-im-a-breast-cancer-surgeon-this-is-what-surviving-cancer-myself-taught-me/GWGO5EWTRNFAHB7MLHU5SGPTIM/ In her own 'blog' - she writes candidly - from her own diagnosis, surgery, chemo, tabs & treatment overall with all the same fears and side effects that many of us have experienced .... Read her personal story here (then click on her 'blog': http://liz.oriordan.co.uk/ You can follow her on Instagram too https://www.instagram.com/oriordanliz - work your way thru her videos ..... they are authentic & helpful She has announced a New trial in the UK, attempting to identify younger women with higher risk of breast cancer BEFORE diagnosis - particularly those with dense breast tissue .... leading to earlier intensive testing before the 'normal age' of 40 https://www.instagram.com ; /p/Ct_-RRUINgJ/. (copy & join these 2 parts of the link, to see it as it won't load here.) Nina Lopez (who Liz interviews in one of the videos - add 'this link' after the '.instagram.com bit ... p/Ct2ESwoIkwn/) who talks about HER triple Negative BC here: https://www.the-c-list.com/stories/nina-lopez-39-shares-her-story-of-motherhood-treatment-and-resilience-as-she-lives-with-secondary-breast-cancer And below, are some of the subjects that she covers on Instagram ..Targeted clinical trial for patients with lymphoedema related to breast cancer surgery
Hi members, The below clinical trial conducted by LeapCure may be of interest to some of you. If you have breast cancer surgery related lymphoedema following a dissection or biopsy procedure, you could be eligible to join a clinical trial that is enrolling nearby. Initial eligibility includes lymphoedema patients who have had surgery for their breast cancer at least 6 months ago and diagnosed with lymphoedema within the past 4 years. The following pre-screener will help you determine your suitability, match you to a nearby trial site, and enter you on to a list for the LeapCure team to give you a call back. To help you determine if you are eligible for the study, LeapCure, who are administering the recruitment of this study in Australia, have developed a survey found at the link below. By taking this survey, you are providing your consent (agreement) for LeapCure to collect and store your survey answers on an overseas server (large computer) that is compliant with the Health Insurance Portability and Accountability Act (USA). Here is the pre-screening link: https://research.leapcure.com/studies/bclymph?locale=en-AU&utm_source=BCNA&utm_medium=mixed&utm_campaign=060921Pv22&utm_cat=PAGNWAU&utm_study=bclymph
Cancer Drugs Approved Quickly Often Fail To Measure Up Later
Online article published 28 May 2019 https://www.npr.org/sections/health-shots/2019/05/28/727598045/cancer-drugs-approved-quickly-often-fail-to-measure-up-later?utm_source=Color+Client+Newsletter&utm_campaign=d0ae11a21f-Spectrum_6_2019&utm_medium=email&utm_term=0_07102bacdf-d0ae11a21f-226561061 Cancer drugs that speed onto the market based on encouraging preliminary studies often don't show clear benefits when more careful follow-up trials are done, according to research published Tuesday. These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe. In 2018, the FDA looked back on 93 cancer drugs granted accelerated approval and touted that only five had been removed from the market over a 25-year span. A research team at Harvard Medical School's Program on Regulation, Therapeutics and Law dug deeper to see what had happened with the rest. In the follow-up studies, only 19 of the 93 drugs clearly extended the lives of the patients taking them, according to the study, published in the latest JAMA Internal Medicine. For example, Genentech's Avastin, or bevacizumab, won accelerated approval to treat the deadly brain cancer glioblastoma, but the drug did not extend the lives of patients in a follow-up study. Sometimes patients value drugs because they improve their quality of life. This drug didn't do that either, yet the FDA left it on the market as an approved treatment for glioblastoma. "So that was the most baffling thing," says Bishal Gyawali, an oncologist on the research team. "I find it very difficult to understand." The researchers said follow-up studies for these cancer drugs often didn't even use overall survival or improved quality of life as the benchmark. Instead, many used the same measure that formed the basis for their preliminary approval — for example, tumor shrinkage. Those targets, called "surrogate endpoints," often don't predict who will live longer or more comfortably. "How can we use the same surrogate endpoint and say they have clinical benefit in a confirmatory trial?" Gyawali asks, when that endpoint clearly wasn't sufficient for full approval of the drug at the outset. (Gyawali is now at Queens University in Ontario.) "The reason for giving these approvals should be transparent," he says, but the FDA doesn't explain its reasoning. A second study in the same issue looked at cancer drugs approved based on a specific surrogate endpoint called "response rate." Response to a drug can be anything from spectacular and complete remission to weak and transitory shrinkage of a tumor. And these responses don't necessarily mean people will live longer or be more comfortable. The study looked at 59 cancer drugs approved initially on the basis of their response rate and found that just six eventually won regular approval based on their overall survival benefit. Studies based on response rate don't include a comparison group, so the scientists at Oregon Health and Science University argue that it's difficult to say whether these new drugs are better than other drugs already on the market. Sometimes there is no comparison group because these are rare cancers, or the drug targets a rare mutation in a common cancer, so it's difficult to pull together a study that randomizes patients into different treatment groups, says Dr. Richard Schilsky, the senior vice president and chief medical officer at the American Society of Clinical Oncology. But for other circumstances, "if we put the investment in it we would be able to do randomized controlled trials," says Emerson Chen, an oncology fellow at OHSU. Those studies often add another year or more to a follow-up study, he says, but he advocates for them because they provide "more definitive information about the survival and the patient-reported outcomes." "One of the reasons we don't do those kinds of studies is that people say these drugs are so potent it would be wrong to do those kinds of studies ... ethically or practically," says oncologist Vinay Prasad, senior author of the paper. "But I think what we find is these drugs unfortunately are not that potent." In a commentary, Dr. Ezekiel Emmanuel and colleagues at the University of Pennsylvania write that there "is no good reason for the FDA to rely so heavily on accelerated approval using response rates or other unreliable surrogate end points." "Drugs with unproven effectiveness sell false hope to desperate patients, who are likely paying thousands of dollars out of pocket for them," they write, adding, "Approval of ineffective drugs also crowds out innovation that might produce effective treatment." The FDA gets pressure both from patients and from drug companies to accelerate approval of new cancer drugs and constantly needs to strike a balance between innovation and caution, ASCO's Schilsky says. Randomized trials are the gold standard for cancer research, but he says they can be challenging if a drug is already on the market. "When the preliminary results with some of these new treatments are looking very promising, it's particularly difficult to get patients to accept randomization to a standard therapy that may be far inferior — or at least appear to be far inferior — to the new treatment," Schilsky says. He also pushes back against the "sweeping generalizations" in these two studies. "Regulatory decisions have to be made on a case by case basis and in a particular context," he says. But he agrees that the FDA should be more transparent about its decisions, so scientists can better understand them. The FDA did not provide NPR with details about its decision to leave Avastin on the market for brain cancer. In a statement, an agency spokeswoman notes that the FDA weighs risk and benefits, saying, "It has been widely accepted that benefit can be demonstrated by a number of endpoints, not just overall survival." You can contact NPR science correspondent Richard Harris at rharris@npr.org.A new clinical Trial in Australia - Ember-4 (Endocrine/AI alternative) - has anyone heard of it?
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (These links show other BC Trials that are currently 'open' in Australia - but only the WA page mentions Ember-4 ... ) https://www.breastcancertrials.org.au/research/open-clinical-trials/ https://bcrc-wa.com.au/open-clinical-trials/ https://trials.cancervic.org.au/search/ (Put Breast Cancer in the search area) https://www.australianclinicaltrials.gov.au/anzctr-search-results?search_text=breast%2Bcancer&condition_category=all&condition_code=all&recruitment_status=Recruitingðics_approval=Yes Not sure if this will help anyone - it is a different form of AI they are 'testing' ... I found this info on the Ember-4 trial on one of the Facebook BC sites ..... (BTW, this is NOT written by me and does not relate to me in any way .. ) (SERDs are an important endocrine therapy used to treat ER-positive breast cancer. Parenteral SERD Fulvestrant has been approved and used in the treatment of metastatic ER-positive breast cancer for the last 2 decades.) From a Facebook BC Post: Is anyone else on the Ember-4 trial? I found out yesterday that I was selected in the trial to get Ilumestrant (a new SERD that replaces your AI) so that is quite exciting, but I ended up with horrible diarrhoea yesterday after taking my first dose, so hopefully that is not a side-effect that continues… Ilumestrant is a Selective Estrogen Receptor Degrader (SERD) that you take instead of taking an oestrogen blocker or aromatase inhibitor… it degrades the estrogen receptor sites in the cancer cells rather than blocking your oestrogen, so it allows your body to have some oestrogen and hopefully less joint aches and pains etc… An interesting thing about it is that you must fast for one hour before you take it, and for two hours after you take it. This will not be an issue for me, but I imagine it could be hard in some situations.Triple Negative Vaccine hopes to eliminate the disease - we need these trials in Australia NOW!
This is in the UK newspaper today - hopefully these trials will be in Australia SOON .... Maybe Ask your Onc about this ..... the sooner it starts here, the better. Triple Negative Breast cancer vaccine 'could eliminate disease by 2030' : 15 women who survived aggressive tumours are still in remission up to five years later after receiving experimental shot — now doctors believe a cure is in sight https://www.dailymail.co.uk/health/article-12140391/Breast-cancer-vaccine-eliminate-form-disease-seven-YEARS.html and another report from Dec 2022 https://www.dailymail.co.uk/health/article-11400715/Three-cancer-patients-cured-experimental-vaccine-100x-cheaper-rival-shots.html
