RecruitingOBSERVATIONAL

Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer

The PEAK study is investigating how things like your menstrual cycle, hormone treatments, and specific tests on your tumour called PAM50 and Ki67 influence decisions about treatment for a common type of breast cancer (Hormone Receptor Positive, HER2 Negative). Researchers want to see if the menstrual cycle affects how quickly the cancer cells grow. They also want to understand if certain genetic tests (PAM50) alongside cell growth markers (Ki67) help doctors make better choices about what treatments to recommend. This is a non-interventional study, meaning it observes patients' care as it happens in the clinic, rather than giving them new, experimental treatments.

At a glance

Status

Recruiting

Sponsor

University Hospital Tuebingen

Enrolment target

504

Start

25 Apr 2023

Estimated completion

01 Apr 2035

Hormone Receptor Positive HER-2 Negative Breast Cancer

What is this study about?

The PEAK study is looking at how various things might affect the growth of breast cancer cells and which treatments doctors decide to recommend. It focuses on a common type of breast cancer that is sensitive to hormones and doesn't have too much of a protein called HER2.

One big question the study is trying to answer is whether a woman's menstrual cycle affects how fast her cancer cells grow. To make sure their findings are accurate, they'll also look at women who have gone through menopause. The study will also examine how certain hormone treatments given before surgery might impact the cancer. On top of that, they're using two specific tests: Ki67, which measures how quickly cancer cells are dividing, and PAM50, which is a genetic test that gives more information about the cancer's behaviour. The researchers want to see if these tests, along with changes in cell growth, help doctors make the best decisions about follow-up treatments.

Ultimately, this study aims to help doctors understand the information they get from these tests and from a woman's body (like her menstrual cycle) so they can choose the most effective and personalised treatments for breast cancer, improving the chances of a good outcome.

Key takeaways

Study looks at Hormone Receptor Positive, HER2 Negative breast cancer.
Investigates impact of menstrual cycle, hormone therapy, and specific tumour tests (Ki67, PAM50) on treatment decisions.
Observational study – participants receive standard medical care, no experimental treatments.
Aims to improve personalized treatment recommendations for future patients.
Primarily for women having surgery at Tuebingen or Freiburg and receiving pre-surgery hormone treatment.

Who may be eligible?

To be considered for this study, you need to be a woman aged 18 or over. You must have a specific type of breast cancer that has been confirmed by a biopsy: it should be hormone-sensitive (meaning it responds to hormones) but not HER2-positive. Your cancer should also be confined to one breast and not have spread to your lymph nodes. Importantly, your doctors must be planning for you to have surgery at the Department for Women's Health in Tuebingen or Freiburg, and you should be scheduled to receive certain hormone treatments (like Tamoxifen or Aromatase inhibitors) or no treatment, for a few weeks before your surgery.

You would not be able to join if your breast cancer is HER2-positive or not sensitive to hormones. Also, if you have had other cancers recently, or if you need chemotherapy before your surgery, you wouldn't be suitable. The study also isn't for those who are pregnant or breastfeeding, or if you've used hormonal contraception in the last six months. They need to ensure participants are healthy enough for typical cancer treatments.

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.

Are you a woman aged 18 or older?
Do you have hormone-sensitive, HER2-negative breast cancer?
Is your cancer only in one breast and hasn't spread to lymph nodes?
Are you planning to have surgery at Tuebingen or Freiburg?
Will you be taking hormone treatments (or no pre-surgery treatment) before your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the PEAK study, you don't receive any new, experimental treatments. Instead, the study observes your usual care. This means your doctors will follow their standard practice for your breast cancer treatment. You would likely undergo a biopsy to check your tumour characteristics, and if prescribed, you would take standard hormone treatments for 2-4 weeks before your surgery. The study involves collecting information from your medical records and samples taken during your routine care, such as from biopsies or during surgery. There are no extra visits or procedures specifically for the study beyond what your doctor has already planned for your treatment. The study will look at this information to understand how your care and your body's factors (like your menstrual cycle) relate to your cancer's behaviour.

Potential risks and benefits

By taking part in this study, you won't experience direct personal benefits, as it doesn't involve new treatments for you. However, the information gathered could help future breast cancer patients by improving our understanding of how to tailor treatments. As this is an observational study, the risks are minimal and mainly involve the use of your existing medical data and tissue samples, all handled with strict confidentiality. You are free to ask any questions and can withdraw from the study at any time without it affecting your medical care.

Locations (1)

Department of Women's Health
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What kind of breast cancer is this study for?

It's for a common type of breast cancer that's sensitive to hormones (Hormone Receptor Positive) and is not HER2-positive.

Will I get new treatments in this study?

No, this study is 'non-interventional,' meaning you'll receive your usual, standard care as planned by your doctors.

What is Ki67 and PAM50?

Ki67 is a marker that shows how fast cancer cells are growing. PAM50 is a genetic test that gives more detailed information about your cancer type.

Does my menstrual cycle really matter for breast cancer?

Researchers are studying if and how your menstrual cycle might affect the growth rate of your cancer cells. This is one of the main questions of the study.

Who is running this study?

This is an 'investigator-initiated trial' (IIT), meaning it's started and managed by the researchers themselves, often at a university or hospital.

How to find out more

Dominik Dannehl, Dr.

dominik.dannehl@med.uni-tuebingen.de 07071 29 82211 Official trial record

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