Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PREOPERATIVE WINDOW OF OPPORTUNITY STUDY WITH GIREDESTRANT (GDC-9545) OR TAMOXIFEN IN PREMENOPAUSAL WOMEN WITH ER[+]/HER2[-] & KI67≥10% EARLY BREAST CANCER

This research study is for women who haven't yet gone through menopause and have a specific type of early breast cancer (ER-positive, HER2-negative, and with a high Ki67 score). The study wants to find out how well a new medicine called giredeastrant, or an existing one called tamoxifen, work to slow down cancer cell growth before surgery. Doctors will take a small sample of the cancer before and after a short period of treatment to see the changes. This helps them understand which treatment might be more effective at tackling the cancer cells early on. The study is in its second phase, meaning it's still exploring how safe and effective these treatments are.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

Start

29 May 2023

ER[+]/HER2[-] & Ki67≥10% early breast cancer (EBC)

What is this study about?

This study is particularly for women who are still having their periods (premenopausal) and have been diagnosed with a certain type of early breast cancer. This type is generally sensitive to hormones, usually grows quite quickly, and can be helped by hormone-blocking treatments.

The main goal of the study is to test two different treatments, a new drug called giredeastrant and a commonly used drug called tamoxifen. Both of these drugs are designed to target and slow down the growth of breast cancer cells. Researchers want to see how much these treatments can reduce the number of fast-growing cancer cells in your breast before you have surgery. They'll do this by looking at small samples of your cancer before and after you take the study medication for a short time.

By carefully comparing the effects of these medicines, scientists hope to learn more about how they work and which might be better at shrinking or controlling this type of cancer early on. This information is really important because it could lead to better treatment plans for women with early breast cancer in the future, potentially improving outcomes and making treatments more effective.

Key takeaways

This study is for premenopausal women with a specific type of early breast cancer.
It compares a new drug (giredeastrant) with a standard one (tamoxifen) before surgery.
The main goal is to see how these medicines affect cancer cell growth.
You'll have biopsies before and after a short treatment period.
Participation helps scientists find better early breast cancer treatments.
You can stop participating at any time.

Who may be eligible?

This study is specifically designed for women who are at least 18 years old and have not yet gone through menopause.

You would need to have been diagnosed with early breast cancer that has certain characteristics: it must be sensitive to hormones (ER-positive), not have too much of a protein called HER2 (HER2-negative), and the cancer cells must be growing quite quickly (Ki67 score of 10% or higher).

There might be other health requirements or previous treatments that could affect whether you can join, but the doctors involved in the study will be able to explain all of these details to you.

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 female and aged 18 or over?
Are you still having your periods (premenopausal)?
Have you been diagnosed with early breast cancer?
Is your breast cancer known to be ER-positive and HER2-negative?
Does your cancer have a Ki67 score of 10% or higher?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a small biopsy (a tissue sample taken) of your breast cancer. Then, you would start taking one of the study medications, either giredeastrant or tamoxifen, for a short period before your planned breast cancer surgery. During this time, you would have regular visits to the clinic for check-ups and to see how you're responding to the treatment.

Before your surgery, you would have another biopsy to see what changes have happened to the cancer cells after the treatment. Doctors will also check various markers in your blood and conduct other tests to understand the medicine's effects. The study will also keep track of any side effects you might experience. The total duration of the specific treatment period before surgery would be quite short, but there might be follow-up appointments after that to monitor your health.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as contributing valuable information that helps improve future cancer treatments. You might also receive a new medication that could be effective for your cancer. However, as with any medical treatment, there are potential risks and side effects associated with the study medications. These will be carefully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France

Common questions

What kind of cancer is this study for?

This study is for women who haven't yet gone through menopause and have a specific type of early breast cancer that is sensitive to hormones and growing relatively quickly.

What will I have to take if I join the study?

You will take either a new medicine called giredeastrant or a commonly used medicine called tamoxifen for a short time before your surgery.

Why do I need two biopsies?

Doctors need to take a small sample of your cancer before and after you take the study medicine to see how the medicine has affected the cancer cells.

What does 'Phase II' mean for a study?

Phase II means the study is still exploring how safe and effective the treatments are, often involving a larger group of people than initial tests, but not yet thousands.

Will I still have my surgery if I join the study?

Yes, this study involves taking the medication for a short time *before* your planned breast cancer surgery.