Active not recruitingPHASE1INTERVENTIONAL

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

This research study is investigating a new medication called GDC-9545 for women with advanced breast cancer that is sensitive to hormones (Estrogen Receptor-positive) and has spread to other parts of the body, or come back. The main goals are to understand if GDC-9545 is safe to use, how the body handles it, and if it can help shrink or control the cancer. The study will test GDC-9545 by itself, and also in combination with palbociclib and/or a hormone treatment called LHRH agonist. This type of early-stage study helps doctors learn more about promising new treatments for breast cancer patients.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

181

Start

24 Nov 2017

Estimated completion

31 Jul 2027

Breast Cancer

What is this study about?

This research study is focused on a new drug called GDC-9545 for a specific type of breast cancer. This cancer is known as 'Estrogen Receptor-positive' (or ER-positive), meaning its growth is often encouraged by the natural hormone oestrogen. It's also 'HER2-negative', which helps doctors decide on the best treatments. The cancer in this study has either spread to other parts of the body (metastatic) or returned locally and can't be removed by surgery or treated with radiotherapy with a chance of cure. This study is an early-stage trial (Phase 1), which means it's one of the first times this new drug is being tested in people.

The main aim of this study is to find out if GDC-9545 is safe to use and what doses are best. Researchers will also look at how the body processes the drug and if it seems to have any effect on the cancer. They want to see if the drug works when given alone, or if it's more effective when combined with other existing treatments like palbociclib (a type of targeted therapy) or an LHRH agonist (a hormone therapy that reduces oestrogen levels).

Learning about new treatments like GDC-9545 is really important for improving care for people with advanced breast cancer. Even if a drug doesn't cure cancer, extending life or improving quality of life for patients is a very valuable outcome. Studies like this help scientists understand more about how cancer responds to different medicines, paving the way for future treatment options.

Key takeaways

This study is testing a new drug, GDC-9545, for advanced hormone-sensitive breast cancer.
It's a Phase 1 study, mainly focused on safety and finding the best dose.
The drug will be tested alone and with other standard breast cancer treatments.
Participation involves regular clinic visits, blood tests, scans, and biopsies.
You must have ER-positive, HER2-negative breast cancer that has progressed on previous hormone therapy.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women who have advanced breast cancer that is Estrogen Receptor (ER)-positive and HER2-negative. This means your cancer is sensitive to the hormone oestrogen and doesn't have too much of a protein called HER2. Your cancer must have spread to other parts of the body or be a local recurrence that can't be treated effectively with surgery or radiation.

To join, your cancer must have either come back or gotten worse after you've already had at least two years of hormone treatment for early breast cancer, or if you've received hormone treatment for advanced cancer and it helped keep your cancer stable for at least six months. You shouldn't have had more than two previous treatments for your advanced breast cancer. It's also important that at least two weeks have passed since your last endocrine (hormone), targeted, or chemotherapy treatment.

For some parts of the study, you shouldn't have had a specific type of drug called a CDK4/6 inhibitor before. If you're having a special scan called a FES-PET, there are also specific timeframes since you last took certain hormone treatments (like tamoxifen or fulvestrant). Generally, you need to be past menopause and be well enough to carry out most of your usual daily activities without much help.

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.

Do I have advanced breast cancer that is Estrogen Receptor-positive and HER2-negative?
Has my cancer spread or come back in a way that can't be cured by surgery or radiation?
Have I already had hormone therapy for my advanced breast cancer and it worked for at least 6 months, or had at least 2 years of adjuvant hormone therapy?
Have I had no more than two previous treatments for my advanced breast cancer?
Am I generally well and able to mostly take care of myself?
Am I past menopause?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either GDC-9545 on its own, or GDC-9545 combined with other approved treatments like palbociclib and/or an LHRH agonist. The study will involve regular visits to the clinic for medical checks, blood tests, and scans to see how you are responding to the treatment. You will also have a small procedure called a biopsy before treatment and during treatment. This involves taking a tiny sample of your tumour to help researchers understand how the drug works. The total duration of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Participating in this study might offer a chance to receive a new medication that is not yet widely available, and it could potentially help control your cancer. However, as with any new treatment, there are unknown risks and side effects that we may not fully understand yet. Your medical team will carefully explain all known risks. You can choose to leave the study at any time, for any reason, without it affecting your future care.

Locations (23)

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

University of Colorado
Verified postcode
Aurora, United States
Massachusetts General Hospital.
Verified postcode
Boston, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Vanderbilt University Medical Center
Verified postcode
Nashville, United States
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia
Peter Maccallum Cancer Centre
Verified postcode
Melbourne, Australia
National Cancer Center
Verified postcode
Gyeonggi-do, South Korea
Seoul National University Hospital
Verified postcode
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Verified postcode
Seoul, South Korea
Asan Medical Center
Verified postcode
Seoul, South Korea

Common questions

What is 'Estrogen Receptor-positive' breast cancer?

This means your breast cancer cells have a 'receptor' (a kind of switch) that responds to the hormone oestrogen, which can make the cancer grow. Treatments often aim to block this.

What is 'HER2-negative' breast cancer?

This means your cancer cells don't have too much of a protein called HER2 on their surface. This helps doctors choose which treatments are most likely to work for you.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started in the breast to other parts of the body, such as bones, lungs, or liver.

What is a 'Phase 1' study?

A Phase 1 study is an early stage of clinical research where a new drug is given to people for the first time. The main goals are to check its safety, find the best dose, and see how the body handles it.

Will I get the new drug, or a dummy pill?

In this Phase 1 study, all participants will receive the active study drug, GDC-9545, either on its own or in combination with other approved treatments. There won't be a dummy pill (placebo).