All studies
Active not recruitingPHASE3INTERVENTIONAL

Trial of Perioperative Endocrine Therapy - Individualising Care

This study, called 'Trial of Perioperative Endocrine Therapy - Individualising Care', focuses on postmenopausal women with a specific type of breast cancer that is sensitive to hormones. Researchers want to see if giving a hormone-blocking medicine, called an aromatase inhibitor, for a short period before surgery, along with the usual treatment, helps improve recovery compared to just the usual treatment. The study also aims to understand why some cancers respond better to treatment than others. By looking at certain markers in the tumour tissue both before and shortly after starting the hormone medicine, doctors hope to predict who will benefit most. This could lead to more personalised and effective care for each patient.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Institute of Cancer Research, United Kingdom
Enrolment target
4,486
Start
01 Sep 2008
Estimated completion
01 Apr 2034

What is this study about?

This important study is looking into ways to make breast cancer treatment even better for postmenopausal women. If you've been diagnosed with breast cancer that's sensitive to hormones, your doctor might talk to you about this trial.

The main idea is to compare two approaches. One is the standard treatment you would normally receive. The other is adding a short course of a hormone-blocking medicine called an aromatase inhibitor (often shortened to AI) just before your surgery. These medicines work by lowering the amount of oestrogen in your body, which can help slow down or stop the growth of certain breast cancers. The researchers want to find out if this extra step before surgery leads to better long-term results than standard treatment alone.

Beyond simply giving treatment, this study also aims to understand how your specific cancer responds. When tissue samples are taken, researchers will look at certain features within the cancer cells. They'll compare these features from before you start the AI medicine and again shortly after. This helps them learn if these changes can predict how well you'll do in the long run. The goal is to use this information to give each patient the most effective and tailored treatment possible.

Key takeaways

  • This study is for postmenopausal women with hormone-sensitive breast cancer.
  • It tests adding short-term hormone therapy before surgery.
  • Aims to see if this improves long-term outcomes.
  • Also examines if cell markers can predict treatment success.
  • No extra hospital visits beyond your normal care.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for women who have gone through menopause and have been diagnosed with breast cancer that responds to hormones. To be considered postmenopausal, you'd typically be aged 50 or over and haven't had a period for over a year, or you've had surgery to remove your ovaries. If you're under 55 and have had a hysterectomy or used certain hormone treatments recently, your doctor would check your hormone levels to confirm you're postmenopausal.

Your breast cancer must not have spread to other parts of your body, and it needs to be the type that usually benefits from hormone-blocking treatments. The tumour also needs to be large enough to feel or measure at least 1.5cm on a scan. You should also be generally well and able to consent to take part and provide tissue and blood samples.

You wouldn't be able to join the study if your cancer is very advanced or has spread. If you've had breast cancer before (except for some very early stages), or if you have cancer in both breasts at the same time, this study wouldn't be suitable. Also, if you've recently used hormone replacement therapy (HRT) or other oestrogen-containing medicines, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman who has gone through menopause?
  2. Do you have breast cancer that is known to be hormone-receptor positive?
  3. Has your doctor confirmed your cancer has not spread to other parts of your body?
  4. Is your breast cancer tumour at least 1.5 cm on an ultrasound or can it be felt?
  5. Have you *not* had HRT or any other oestrogen medicines in the last 4 weeks?
  6. Is this your first diagnosis of invasive breast cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some upfront checks to make sure the study is right for you. Your journey would then typically involve starting a course of aromatase inhibitor medicine. This would be taken for about two weeks before your planned breast cancer surgery. During your surgery, tissue samples from your breast cancer will be collected.

After surgery, you'll continue with your standard follow-up care, which will include ongoing hormone therapy if that's part of your usual treatment plan. The researchers will continue to track your health and progress over several years, collecting information from your routine clinic visits. There won't be any extra visits specifically for the study beyond your usual appointments, but your medical information will be used to help the research.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that adding a short course of aromatase inhibitors before surgery might improve your long-term outcome, though this is what the study aims to find out. We don't yet know if this approach is better than standard care. You might experience side effects from the aromatase inhibitors, similar to those that occur when these drugs are used for longer periods, such as hot flashes, joint pain, or fatigue, even for a short time. You are free to withdraw from the study at any time without your medical care being affected.

Locations (128)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Ulster Hospital
    Verified postcode
    Dundonald, United Kingdom
  • Heatherwood and Wexham Park Hospitals NHS trust
    Verified postcode
    Slough, United Kingdom
  • Stoke Mandeville Hospital
    Verified postcode
    Aylesbury, United Kingdom
  • Prince Philip Hospital
    Verified postcode
    Llanelli, United Kingdom
  • Craigavon Area Hospital
    Verified postcode
    Portadown, United Kingdom
  • Wansbeck General Hospital
    Verified postcode
    Ashington, United Kingdom
  • North Devon District Hospital
    Verified postcode
    Barnstaple, United Kingdom
  • City Hospital - Birmingham
    Verified postcode
    Birmingham, United Kingdom
  • Royal Blackburn Hospital
    Verified postcode
    Blackburn, United Kingdom
  • Pilgrim Hospital
    Verified postcode
    Boston, United Kingdom
  • Bradford Teaching Hospitals NHS Trust, St Luke's Hospital
    Verified postcode
    Bradford, United Kingdom
  • Burnley General Hospital
    Verified postcode
    Burnley, United Kingdom

Common questions

What is an Aromatase Inhibitor?

It's a medicine that lowers oestrogen levels in your body, which can help treat hormone-sensitive breast cancers.

What does 'postmenopausal' mean in this study?

It typically means you're aged 50 or over and haven't had a period for more than 12 months, or you've had surgery to remove your ovaries.

Will I still get my normal breast cancer treatment?

Yes, this study involves adding a short pre-surgery treatment to your usual care, not replacing it.

Will taking part mean extra hospital visits?

No, the study gathers information from your regular medical appointments; there shouldn't be extra visits just for the study.

Why is tumour tissue collected during surgery?

It helps researchers understand how your cancer responds to treatment and learn how to individualise care better in the future.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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