Breast Cancer and Aixial Group’s Expertise

Tell us more about you and why your role is essential in supporting breast cancer treatment developments.

My role as Head of Strategic Development and Delivery is to offer support and expertise to potential and existing clients (sponsors) with developing the best strategy for clinical trial planning and delivery that will provide the optimal pathway for achieving their defined goals within specific timelines and budgets. According to recent data, nearly 2.3 million people globally (approximately 12% of all new cancer cases) are diagnosed with breast cancer each year and remains the most common cancer diagnosed among women. With these statistics, it is no wonder that breast cancer trials are the most common of all oncology clinical trials and remain an area of increased focus due to the high incidence rates and significant interest in personalized treatment approaches. Given the number of clinical trials focused specifically on breast cancer, and those trials that also include breast cancer patients, a strategic development plan is key to ensuring trial access to patients that need it and the overall success of the trial in a heavily populated research space.

What are the most recent advancements in breast cancer research and how have treatment options for breast cancer evolved in recent years?

• Like many other cancers, recent breast cancer treatments have been focused on individualized and personalized therapy approaches. Thanks to genomic profiling techniques, physicians are able to use an individual’s genetic profile to help guide treatment decisions, improve outcomes, and assess the risk of recurrence.

• The use of Immunotherapy drugs dates back to more than 20 years ago, however, with the discovery of immune checkpoint inhibitors (ICI) such as PD-1/PD-L1 inhibitors, this space has seen a large growth in research and particularly (in breast cancer) in patients with Triple Negative Breast Cancer (TNBC). Immunotherapy treatment represents a significant advancement in oncology that has demonstrated both durable clinical benefits and anti-tumour activity. We have seen immune checkpoint inhibitors used in both mono and combination therapy (e.g. ICI + chemotherapy) to improve efficacy and defeat challenges with resistance.

• Research is also seeing a large increase in the neoadjuvant space, where breast cancer patients will receive therapy prior to surgical resection in an effort to reduce tumour burden, increase tumour response, and allow for more conservative surgical options.

• We have seen a growth in the area of PARP Inhibitors, for patients with BRCA, which aims to target specific genetic vulnerabilities.

• Finally, we have seen some new hormonal therapy agents used in combination with CDK4/6 inhibitors which have been shown to increase the effectiveness of single-agent hormonal therapies for ER+ breast cancer.

Advancements such as these reflect the shift towards more individualized care, improving outcomes and minimizing the adverse effects associated with traditional treatments. Only through continued research will we be able to discover further breakthroughs and increase our understanding of the best approaches to treating breast cancer and eventually finding a cure!

What are the main challenges that stakeholders in breast cancer research are currently facing?

• Challenges that stakeholders face in breast cancer research range from regulatory hurdles to ethical considerations to costs and access to novel therapies and beyond.

• From an ethical perspective, two recurring challenges are data privacy and proper informed consent. Informed consent (IC) is a key component of any research study to ensure the patient has a full understanding of what research is being done, how it is being funded, what they can expect as a research participant, the potential risks of trial participation, their options for alternate treatment, and more. The IC itself must be detailed enough to fulfil all ICH GCP requirements, but with carefully balanced writing (in plain language) that is easily understandable and allows the patient to make an informed decision without coercion. The informed consent process is the first and most important step in determining if a patient is interested and willing to participate in a clinical trial and must be taken seriously. Not only does the IC process serve to inform patients, it also provides a layer of protection for the patient by providing them with the knowledge of their own rights when participating in a clinical trial. When patients are well informed about a trial, they feel empowered to make choices about their healthcare options, increasing their sense of autonomy, and it encourages patients to ask questions and have discussions with their trusted health care providers. All these things combined also serve to positively impact a trial’s enrollment rate, as well informed patients are more likely to participate in a research study and are also more likely to stay engaged because they understand what to expect, what they have agreed to as a participant in the trial, and what their data will be used for, with whom it will be shared, and for how long their data will be kept. The IC process is equally vital for enhancing patient understanding, trust and engagement as it is to adhering to all legal, ethical and regulatory requirements.

• Patient diversity and access to new, innovative, and affordable therapies are also challenges that stakeholders must address when developing a new protocol and strategy for delivering the trial. To overcome these obstacles, sponsors and key stakeholders must focus on the needs of the patient population and develop a plan to address financial barriers, provide clinical trial education and awareness, and implement flexible trial participation options to increase patient diversity. Community engagement should be one of the main components in the strategy. Partnering with advocacy groups, local healthcare organizations and community groups will assist with raising awareness of the trial, supporting with disease status and clinical trial education, and tailoring culturally appropriate and relevant strategies to broaden the patient outreach in meaningful ways to reach diverse populations. Protocols under development should be scrutinized to determine how and where it is appropriate to implement options for reducing trial participation burden on the patient and to support accommodating their personal work/life schedules outside of the trial. A few areas of increased flexibility and remote trial participation include implementation of eConsent, permitting remote study visits through virtual/ telemedicine visits, incorporating options for wearable devices to remotely monitor patient health status (e.g. ECG, VS), using technology to support ePRO/eCOA that can be completed at home by the trial participants, integrating options for home health care study visits, allowing use of local labs close to a patient’s home, and inclusion of appropriate visit windows when on-site visits are necessary. Finally, the financial aspects for patients must also be examined. Two main financial components that need to be considered are insurance coverage and compensation for participation. Insurance coverage can often be difficult to navigate, and support is often needed – sites participating in a clinical trial should have the appropriate expertise to support patients in obtaining coverage analysis to support understanding of what their individual insurance will cover and any costs outside of those as a result of participating in a clinical trial. Sponsors should be willing and ready to support trial participants with compensation for them and their caregivers for travel time to/from study visits, meals, and even lodging for patients travelling long distances and/or lengthy study visits that require staying close to the research facility to accommodate the study visit schedule and assessments.

Addressing these challenges early in the protocol development and trial planning stages will support increased trial diversity, improve patient experience, and reduce the barriers for patients to participate in clinical trials. Regardless of the strategy developed, continual evaluation and assessment should be conducted to identify what components are working and those that aren’t so that adjustments to the overall plan can be made when and as needed.

How can Aixial Group play a role in the fight against breast cancer, and what is its experience and expertise in the area? 

Aixial as a CRO has played a role in the fight against breast cancer since 1999. While we support more than 20 different therapeutic areas, our core focus has been and remains in the oncology and rare disease space. We have supported the delivery of nearly 40 breast cancer-specific trials (HER2+, ER+, PR+, HR+/-, AR+, TNBC, newly diagnosed, advanced, metastatic, cutaneous, etc.) across phases I-IV around the globe with trial placement at hundreds of research centres from small community centres to large, nationally and globally recognized research institutions; these figures do not include our solid tumour trials that included breast cancer patients. Aixial remains committed to continue our support and provide expertise in planning, guiding, managing, and delivering clinical trials to ensure all breast cancer patients have treatment options. Our team of experts are all oncology experienced, that is where our passion lies, and we will not rest until a cure is found for all types of breast cancer!  

How can Aixial Group optimise clinical trials and improve patient care in breast cancer research?

Aixial has worked closely with small to large biotech and pharmaceutical companies since 1999, providing expertise in clinical trial strategy development, trial management, operations, and delivery. Our team of 1000+ strong individuals are able to support sponsors with services spanning from single-service consultancy to functional support and full-service operations in Project Management, Clinical Monitoring and Site Management, Medical Monitoring, Pharmacovigilance, Biostatistics, Data Management, Regulatory Affairs, and Medical Writing. We tailor our approach to your individual requirements to provide flexible solutions and team models that scale up and down according to your needs for immediate and long-term solutions. We have a global footprint that allows us to navigate complexities in national and local regulations with ease. We have an established global site network that has demonstrated success across more than 1,600 trials; this enables us to identify the best sites to support your clinical trial and direct the site start-up approach with speed and accuracy. Our experience in complex study designs, a broad range of compounds and speciality projects allows us to bring sensible solutions to the challenges faced in clinical research. Aixial also offers a suite of technology solutions for our sponsors (eTMF, CTMS, EDC [multiple offerings], Safety Database, eCTD submission). We will partner with you to develop an optimal strategy for your clinical trial.

Aixial has been working in decentralized and patient-centric trial models for over two decades. We work closely with our sponsors to ensure the protocol language is flexible and incorporates patient-centric solutions such as accommodations for telehealth visits where appropriate, options for home delivery of IP through specialized couriers, in-home infusions, wearable devices to provide remote monitoring of health status, and ample visit windows to name just a few. Our decentralized solutions include the ability to complete all monitoring visit types in a remote fashion – while COVID pushed this into standard practice, Aixial had been performing remote visits for over 20 years in varying degrees. While not every measure is appropriate for all trials, we must maintain our focus on getting clinical trial access to all patients and strive for trial diversity to ensure the products under investigation are available to the masses and not just the few.

Early detection is key. Can you give some guidance on breast cancer screening, and what the risk factors are? 

• According to the National Comprehensive Cancer Network (NCCN) guidelines, breast screening for cisgender females should be “performed on individuals without any signs or symptoms of breast cancer so that disease can be detected as early as possible”, “due to the preponderance of data in this population”. Breast screening guidelines consider an individual’s age, personal medical history, family history, and risk factors. The NCCN suggests that individuals should have a breast cancer risk assessment by the age of 25 years. There are two categories of risk for developing breast cancer: average risk and increased risk.

• For individuals that are of average risk and are between the ages of 25-39, the NCCN recommends “clinical encounter” measures every 1-3 years. A clinical encounter entails a clinical breast examination, a breast cancer risk assessment, and risk reduction and healthy lifestyle recommendations by a qualified health care provider (HCP). Once an individual reaches the age of ≥40, the NCCN recommends adding annual screening mammograms. For individuals with heterogeneous or extremely dense breasts, supplemental screening may be considered and should be discussed with your HCP.

• If an individual is assessed as being at an increased risk, the guidelines vary based on the risk factors such as familial cancers (e.g. cancer type(s), shared environments, family size, genetic variations, or other genetic predispositions).

All screening considerations, regardless of risk level, should be made on a case-by-case basis, tailored precisely for the individual and under the guidance of a qualified healthcare provider.

Why do you think Breast Cancer Awareness Month is so important?

Until the day the question, “Do you know anybody that has suffered with or lost their life to breast cancer?” can be answered with the response of “No” by every single individual across the globe, then there is still more work to do. With over 2 million newly diagnosed individuals each year (and growing with improved detection methods), we are all currently or close to being personally impacted by this disease. Because early detection remains an important first line of defence, raising awareness is critical to ensuring prompt diagnosis and treatment implementation to increase the chance of beating breast cancer.