Active not recruitingPHASE2INTERVENTIONAL

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

This study aims to discover if giving oestrogen for a short time can slow the growth of certain oestrogen receptor-positive (ER+) breast cancers. Some ER+ breast cancers respond well to hormone therapy, while others don't, and scientists don't fully understand why. This research suggests that for some ER+ tumours, oestrogen might actually stop them from growing, rather than making them grow faster. By giving a two-week course of oestrogen (like levels before menopause) just before surgery, doctors will compare how quickly the cancer cells grow in the removed tissue. This could help us understand how to better treat ER+ breast cancers in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

01 Aug 2015

Estimated completion

01 Jun 2028

Estrogen Receptor Positive Breast Cancer

What is this study about?

You might know that some breast cancers grow because of a hormone called oestrogen. These are called oestrogen receptor-positive (ER+) breast cancers. Often, treatments aim to lower oestrogen levels or block its effects. However, doctors have noticed something puzzling: some ER+ breast cancers shrink with hormone treatments, while others don't respond as well.

Recent research has made us wonder if, for some specific types of ER+ breast cancer, oestrogen might actually be helpful rather than harmful. It sounds surprising, but there’s a theory that some of these cancers might struggle to grow when oestrogen levels are higher. This could explain why some breast cancers appear after menopause when natural oestrogen levels drop.

This study is testing this idea. We want to see if giving a short course of oestrogen, similar to levels women have before menopause, for about two weeks before surgery, could slow down the growth of certain ER+ tumours. By looking at the cancer tissue removed during standard surgery, we can compare how quickly the cells have grown after this brief oestrogen treatment. This research is important because it could help us understand these complex cancers better and potentially lead to new ways of treating them in the future.

Key takeaways

This study explores a new theory about how oestrogen affects certain breast cancers.
It involves taking a short course of oestrogen before your planned surgery.
The goal is to see if oestrogen can slow cancer growth in some patients.
It's for women with specific ER+ and HER2-negative breast cancer who are post-menopausal.
Your participation helps to advance our understanding of breast cancer.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for women who have recently been diagnosed with breast cancer that is oestrogen receptor-positive (ER+) and HER2-negative. You must have gone through menopause at least five years ago, and you can't have used hormone replacement therapy in the past. Your breast cancer should be a low to medium grade, and you should generally feel well and be able to take medicines by mouth.

There are also some important reasons why you wouldn't be able to join. For example, if you haven't gone through menopause yet, or if your cancer has spread beyond the breast (locally advanced or metastatic cancer). You also can't have had certain treatments like chemotherapy or radiotherapy for your cancer already, or be planning them before surgery.

Other reasons for not being able to join include having a history of blood clots, heart problems, untreated high blood pressure, or other serious health conditions. You also need to have enough time before your planned surgery to take the study medicine for at least seven days.

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 who has gone through menopause at least 5 years ago?
Have you been diagnosed with oestrogen receptor-positive (ER+) and HER2-negative breast cancer?
Do you generally feel well and are you able to take medicines by mouth?
Have you NOT had previous hormone replacement therapy or other breast cancer treatments like chemo or radiotherapy for this cancer?
Do you have enough time before your planned surgery to take the study medicine for at least 7 days?
Do you have any serious heart conditions, blood clot history, or untreated high blood pressure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a short course of oestrogen medication by mouth for 7 to 14 days before your planned breast cancer surgery. During this time, the research team would closely monitor your health. After this short treatment, you would go ahead with your standard breast cancer surgery as planned. The doctors would then examine the removed cancer tissue to see how the oestrogen treatment affected the growth rate of the cancer cells. There might also be some extra blood tests or tissue samples taken for research purposes, but these will be explained fully. The total time you'd be actively involved with the study medicine before your surgery is about two weeks.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could help future patients with ER+ breast cancer, and a chance for doctors to learn more about your specific cancer. However, this is a research study and there’s no guarantee that you will personally benefit directly. Potential risks might include side effects from the oestrogen medication, though this will be discussed in detail. As with all research studies, you are free to withdraw at any time without giving a reason, and this will not affect your usual care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada

Common questions

What is an ER+ breast cancer?

ER+ (oestrogen receptor-positive) breast cancer means the cancer cells have receptors that allow them to use oestrogen to grow.

Why would oestrogen be given if it helps some cancers grow?

This study is exploring a new idea that for certain types of ER+ cancer, oestrogen might actually slow down their growth, rather than speed it up.

What does 'post-menopausal' mean for this study?

It means you have already gone through menopause and it has been at least five years since your last period.

Will this treatment cure my cancer?

This is a research study to understand cancer better, not a cure. The oestrogen is given for a short time before your planned surgery.

What happens after the 7-14 days of treatment?

After the short treatment period, you will have your standard breast cancer surgery as planned.