Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

This research study is about a type of advanced breast cancer that has certain genetic changes (PIK3CA mutant) and reacts to hormones (hormone receptor-positive, HER2-negative). It's for people whose cancer has grown worse during or shortly after previous hormone therapy, but haven't had other treatments for advanced disease. The study aims to see if adding a new drug, Inavolisib, to two standard treatments, Palbociclib and Fulvestrant, is more effective and safe than using the standard treatments with a dummy pill (placebo). Researchers will watch how the cancer responds to treatment and check for any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

325

Start

29 Jan 2020

Estimated completion

15 Nov 2027

Breast Cancer

Results

Results from this study

Posted October 2024

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.

Full results on the registry

What is this study about?

This study is looking into new ways to treat a specific type of advanced breast cancer. This breast cancer is called 'hormone receptor-positive, HER2-negative', which means it uses hormones to grow and doesn't have too much of a protein called HER2. It also has a particular gene change, known as a 'PIK3CA mutation'.

The aim is to see if a new drug called Inavolisib can improve treatment when used alongside two existing common breast cancer medications: Palbociclib and Fulvestrant. Currently, these two drugs are often used together. The study will compare this new three-drug combination to the standard two drugs plus a placebo (a dummy pill that looks like Inavolisib but contains no active medicine).

Doctors want to find out if the new combination can shrink tumours more effectively, slow down cancer growth, and extend the time people live well, all while keeping side effects manageable. This type of research is very important for finding better treatments for breast cancer patients.

Key takeaways

This study is for a specific type of advanced breast cancer with a PIK3CA gene change.
It tests if a new drug, Inavolisib, improves standard hormone therapy.
Patients will be randomly assigned to receive Inavolisib or a placebo.
Regular monitoring for effectiveness and side effects is a key part of participating.
You must not have had previous systemic treatment for advanced breast cancer.
You can stop participating at any time.

Who may be eligible?

This study is looking for people who have breast cancer that has spread to other parts of the body (metastatic) or is advanced and can't be cured with surgery or radiation. Your cancer must be hormone receptor-positive, HER2-negative, and have a specific gene change called PIK3CA mutation. You would have had your cancer get worse during or within a year of finishing hormone treatment, but you must not have received other treatments specifically for metastatic breast cancer yet.

You would need to be well enough to take part, meaning you can mostly look after yourself. Doctors will check your general health, including blood tests for your liver, kidneys, and blood cells. You also need to have areas of cancer that can be measured on scans. If you have been treated for brain metastases and are now stable, you might still be able to join. However, if you have certain types of aggressive breast cancer (like metaplastic breast cancer) or have diabetes that needs ongoing treatment, you likely won't be able to participate.

Also, if you've had specific types of breast cancer medications, such as fulvestrant or similar drugs (unless it was for a short time before surgery), or drugs that target the PI3K-AKT-mTOR pathway, you won't be eligible. The study is also not for people with certain serious problems like active brain tumours that haven't been treated, or a history of cancer spreading to the fluid around the brain and spinal cord.

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 hormone receptor-positive, HER2-negative breast cancer?
Does my cancer have a PIK3CA gene mutation?
Has my cancer spread or is it locally advanced and not curable?
Has my cancer gotten worse during or within 12 months of finishing hormone therapy?
Have I NOT received any previous treatment specifically for metastatic breast cancer?
Am I generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups by chance, like flipping a coin. One group will receive the new drug Inavolisib, along with Palbociclib and Fulvestrant. The other group will receive a dummy pill (placebo) instead of Inavolisib, along with Palbociclib and Fulvestrant. You won't know which group you are in, and neither will your doctor.

The medications will be taken in cycles. Fulvestrant is given as an injection, and Inavolisib and Palbociclib are pills you take. You'll have regular visits to the clinic for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You'll also be asked to provide a tissue sample of your tumour. The study will continue as long as the treatment is helping you and side effects are manageable. After you stop taking the study drugs, there will be follow-up visits to monitor your health.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, which could potentially work better than standard care for your specific cancer. However, there's no guarantee the new treatment will be effective, and you may experience side effects, some of which could be serious or unexpected. These will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (136)

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

Beverly Hills Cancer Center
Verified postcode
Beverly Hills, United States
Massachusetts General Hospital.
Verified postcode
Boston, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Wake Forest University Baptist Medical Center
Verified postcode
Winston-Salem, United States
Sarah Cannon Research Institute / Tennessee Oncology
Verified postcode
Chattanooga, United States
Sarah Cannon Research Institute / Tennessee Oncology
Verified postcode
Nashville, United States
Texas Oncology - Central South
Verified postcode
Austin, United States
Texas Tech University Health Sciences Center
Verified postcode
El Paso, United States
Texas Oncology - Northeast Texas
Verified postcode
Tyler, United States
Northwest Medical Specialties
Verified postcode
Tacoma, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Verified postcode
Buenos Aires, Argentina
Centro Oncologico Korben
Unverified
Ciudad Autonoma Buenos Aires, Argentina

Common questions

What is PIK3CA-mutant breast cancer?

It's a type of breast cancer with a specific genetic change (mutation) in the PIK3CA gene, which can affect how the cancer grows.

What does 'hormone receptor-positive, HER2-negative' mean?

This means your cancer uses hormones to grow and doesn't have a lot of the HER2 protein, which helps doctors choose the right treatments.

Will I know if I'm getting the new drug or the placebo?

No, you won't know if you're getting Inavolisib or the placebo. This is to make sure the results are fair and unbiased.

What if my cancer gets worse while on the study?

Your doctors will regularly monitor your condition. If your cancer gets worse or you experience unacceptable side effects, you will stop the study treatment and discuss other options with your care team.

How long will I be in the study?

You will remain on the study treatment for as long as it is helping you and you are tolerating it well. After stopping treatment, there will be follow-up appointments to track your health.