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$5.5m grant to develop safer, more effective and more precise breast cancer treatment

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A promising approach to achieve safer, more effective, and more precise breast cancer treatment has earned a University of Virginia researcher a new $5.5 million grant. 

Natasha Diba Sheybani, an assistant professor of biomedical engineering and research director of the Focused Ultrasound Cancer Immunotherapy Center at UVA, is pioneering an approach to metastatic breast cancer treatment that transforms sound waves into active medical instruments.

Her work with focused ultrasound earned her the U.S. Department of Defense Breast Cancer Research Program Era of Hope Scholar Award, designed to support innovative, early career researchers with potential to transform breast cancer treatment and be leaders in the field of breast cancer research and patient advocacy.

With only about a third of patients living past five years from diagnosis, metastatic breast cancer remains incurable.

Chemotherapy, radiation, surgery and newer therapies can slow its spread, but they also take a heavy toll on the body — often introducing safety risks and off-target toxicities to healthy tissues.

For many patients, these treatments buy time rather than remission.

That’s where Sheybani’s work with a safe, emerging interventional tool comes in.

Focused ultrasound, or FUS, is not only poised to advance cancer treatment research, but it’s also set to enable an approach that puts long-term survivorship of the patient front and centre — aiming to target cancer with greater precision and fewer side effects.

Sheybani said: “This grant will deepen our efforts to tackle not only primary breast tumors, but also metastases.

“We are taking a close look at multiple FUS mechanisms of action that are clinically ripe and confronting tough questions like ‘How do we know when we’ve treated enough?’ or ‘How do we decide if we need to shift the course of treatment?’

“To answer these questions, we will harmonize FUS with customised tools for monitoring biological responses in real-time.

“We hope that these novel strategies will allow us to truly deliver on the promise of precision intervention with this technology.”

The Era of Hope Scholar Award will also support a new initiative in collaboration with the UVA Cancer Center that Sheybani will lead — bringing together cancer survivors, caregivers and patient advocates for critical conversations with clinicians, researchers and trainees committed to enabling meaningful translational strides in cancer research.

Diagnosis

FDA delays ruling on ‘game-changer’ breast cancer drug

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The FDA has delayed approval of camizestrant while it reviews new analyses submitted by AstraZeneca after advisers voted against the breast cancer drug.

The US regulator had been considering whether to approve the oral treatment after a phase 3 switching study in a specific group of breast cancer patients.

Camizestrant is an oral SERD, or selective oestrogen receptor degrader. These drugs are designed to block and break down oestrogen receptors that can help some breast cancers grow.

AstraZeneca filed for approval based on the phase 3 Serena-6 trial, which tested a treatment-switching approach.

Patients in the study received an aromatase inhibitor and a CDK4/6 inhibitor. Aromatase inhibitors lower oestrogen levels, while CDK4/6 inhibitors are targeted cancer drugs that help slow cancer cell growth.

After detecting an ESR1 mutation, investigators switched the aromatase inhibitor to camizestrant.

An ESR1 mutation is a change in a gene linked to the oestrogen receptor. It can make some breast cancers less responsive to standard hormone treatments.

AstraZeneca said switching to camizestrant was linked to a 56 per cent increase in progression-free survival.

Progression-free survival measures how long a patient lives without their disease getting worse.

However, the FDA raised questions about the study design.

An FDA advisory committee later voted six to three that AstraZeneca had failed to show camizestrant provides a clinically meaningful benefit.

The vote was a setback for the company’s hopes of approval, although the FDA can go against advisory committee recommendations.

After the setback, AstraZeneca submitted additional analyses requested by the FDA.

The company said the analyses include data on circulating tumour DNA clearance linked to longer-term efficacy outcomes.

Circulating tumour DNA refers to fragments of genetic material from cancer cells that can be found in the blood.

AstraZeneca is expected to share the data next week at the American Society of Clinical Oncology annual meeting.

The FDA has now delayed its ruling while it reviews the additional information. AstraZeneca did not provide a new decision date.

Three-month delays are typical and, during the second Trump administration, have been common.

After budget cuts reduced its workforce, the FDA delayed rulings on assets including Bayer’s Lynkuet, Biohaven’s troriluzole and Sanofi’s tolebrutinib. The FDA reportedly blamed a “heavy workload and limited resources” for one delay.

The agency has continued to delay rulings this year, with Biogen, Savara and Travere Therapeutics among the companies to say the FDA has extended reviews of their drugs.

Like AstraZeneca, those three companies faced delays after submitting additional information that the agency needed time to review.

If the additional analyses address the regulator’s concerns, AstraZeneca could still secure approval for a drug it has estimated could generate peak sales of more than US$5bn.

Guggenheim Securities analysts recently described the Serena-6 study as “a limited commercial opportunity in our and [AstraZeneca’s] view”.

AstraZeneca is also running two adjuvant studies and a trial in a first-line setting as it seeks to position camizestrant across different stages of breast cancer care.

Adjuvant treatment is given after primary treatment, such as surgery, to reduce the risk of cancer returning. First-line treatment is the first therapy given for a disease.

Roche reported the failure of its rival oral SERD in first-line breast cancer in March, but AstraZeneca executives have argued that their trial designs and drug candidate are different.

Last week, Europe’s Committee for Medicinal Products for Human Use issued a positive opinion on camizestrant.

The drug is expected to be marketed as Etcamah in Europe.

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Cancer

Early PET scan could chemo response in aggressive breast cancer – study

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An early PET scan after one cycle of chemotherapy may help predict how aggressive breast cancer responds to treatment, a study suggests.

Research led by The Institute of Cancer Research, London and King’s College London suggests that an early scan taken after one cycle of chemotherapy could help predict how well a patient’s cancer will respond to treatment.

The study focused on patients with triple-negative breast cancer (TNBC), an aggressive form of the disease in which cancer cells lack receptors for the hormones oestrogen and progesterone, as well as the HER2 protein.

Patients with TNBC are usually treated with chemotherapy prior to surgery. While many respond well, residual disease at surgery, typically around six months later, is associated with a significantly poorer prognosis. Identifying people sooner who are unlikely to respond remains a major clinical challenge.

The research explored whether using PET imaging shortly after treatment begins, rather than relying only on MRI scans later in the treatment process, could provide earlier insight into how a patient’s cancer is responding. Twenty-two patients were recruited, with fourteen undergoing FDG-PET scans before treatment and after the first cycle of chemotherapy.

The findings, published in Clinical Cancer Research, showed that changes seen on PET scans after just one cycle of chemotherapy were strongly associated with subsequent response, including whether there was no detectable cancer, known as a complete response, by the end of treatment. Importantly, early PET response showed stronger associations with treatment outcomes than standard mid-treatment MRI scans in this study.

Being able to identify patients who are not responding well at an early stage could allow clinicians to adjust treatment sooner or consider alternative approaches. These findings may also support future strategies to better tailor treatment intensity to individual patients.

The study also compared two types of PET tracers, FDG and FLT, to determine which was most suitable. While both met the study’s technical criteria, FDG-PET was selected for further evaluation due to its better image quality, greater consistency and wider use in clinical practice.

The research also explored how imaging changes after just one cycle of chemotherapy relate to the body’s immune response to treatment. Biopsies taken before and after the first cycle of chemotherapy showed that an increase in immune cells within the tumour was strongly associated with both early PET changes and improved treatment outcomes.

The researchers emphasise that these findings now need to be validated in larger studies. Future work will aim to confirm these results in broader patient groups and explore more accessible imaging approaches, such as ultrasound, alongside PET and MRI.

Sheeba Irshad, professor of cancer immunology at King’s College London and lead of the Breast Cancer Now KCL Research Unit, said:

“In patients who had PET scans both before treatment and after the first cycle, we found that this early scan could predict whether they were likely to achieve a complete response by the end of treatment. These findings highlight the potential of early imaging to guide treatment decisions, and now need to be validated in larger, modern clinical trials.”

Andrew Tutt, professor of breast oncology at The Institute of Cancer Research, London, said:

“Research that helps us determine early who is already benefitting from standard neoadjuvant chemotherapy and who might benefit from clinical trials to find better treatments is vital. This study shows that FDG-PET may have great value in this regard. We hope to be able to design studies that further investigate and validate these findings.”

The study was supported by funding from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, Breast Cancer Now, Cancer Research UK, and Guy’s and St Thomas’ Charity.

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Diagnosis

Women unaware of gynaecological cancers

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Only one per cent of women can name all five gynaecological cancers, new research suggests, as 21 women in the UK die every day of the diseases.

The report also found that 31 per cent of women have put off or avoided seeking medical advice for gynaecological symptoms.

It also found that 43 per cent of women invited for cervical screening said barriers had put them off attending, while 18 per cent of respondents aged 25 to 34 who had been invited had never attended.

The five main gynaecological cancers are womb, also called uterine, ovarian, cervical, vulval and vaginal cancer.

The Lady Garden Foundation said that, while progress has been made since the UK government’s 2022 Women’s Health Strategy aimed to improve gynaecological cancer care, significant challenges remain.

John Butler, medical director and trustee at the Lady Garden Foundation, said: “The fact that only one per cent of the population can name the diseases that directly affect half of us underscores a significant awareness gap, impacting individuals’ ability to recognise vital signs and symptoms or seek timely medical help.

“Addressing this isn’t just about awareness; it’s a critical public health priority. Our collective efforts are essential to ensure the latest commitments announced by this government translate into tangible change that saves lives.”

The report said key reasons for delaying medical advice included difficulty making appointments, embarrassment and, for cervical screening, fear of pain or previous bad experiences.

Women also reported challenges within healthcare interactions, including feeling “not taken seriously”, “dismissed” or “not believed” when seeking gynaecological advice.

Jenny Halpern Prince, chief executive and charity co-founder, said: “We frequently hear reports of women feeling ‘not taken seriously,’ ‘dismissed,’ or ‘not believed’ when seeking gynaecological advice.

“These experiences highlight crucial areas where we can improve patient support and trust within our healthcare system, ensuring women receive the empathetic and effective care they need.”

The Lady Garden Foundation said it aims to increase awareness of both the charity and the five gynaecological cancers.

It also aims to serve as a primary entry point for reliable, stigma-free information, helping people understand their bodies, recognise symptoms and overcome barriers to accessing care.

Its Silent No More Garden was unveiled at the RHS Chelsea Flower Show 2026. Designed by Darren Hawkes, the garden serves as a national call to action, using five sculptures to spark conversations, break long-standing taboos and encourage open dialogue about symptoms and preventative care.

Butler said: “Continued focus and collaborative action are essential to progress.

“The ongoing commitment from the government, alongside societal efforts to break down taboos surrounding gynaecological health, are crucial.

“The Lady Garden Foundation is dedicated to being a beacon of information and support, empowering women with the knowledge they need. We urge everyone to learn the signs, speak up, and help us save lives.”

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