All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

This research study is for people with advanced breast cancer that has either spread to other parts of the body (metastatic) or is too advanced to be removed by surgery (locally advanced). Doctors are testing several new treatment combinations to see how effective and safe they are. The study is divided into different groups, called cohorts, based on the type of breast cancer a person has and what treatments they've had before. For example, some groups focus on triple-negative breast cancer, while others look at hormone receptor-positive or HER2-positive types. The aim is to find better ways to treat these complex forms of breast cancer.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
792
Start
30 Mar 2018
Estimated completion
30 Sep 2030

What is this study about?

This study is designed to explore new and potentially better ways to treat advanced breast cancer. This means breast cancer that has either spread to other parts of your body (doctors call this 'metastatic') or is very advanced in its original location and can't be removed with surgery (called 'inoperable locally advanced').

The main goal is to test various combinations of existing and new medications. Doctors want to understand how well these combinations work together to fight the cancer, and importantly, ensure they are safe for patients. The study is set up like an 'umbrella' because it covers several different types of advanced breast cancer under one research effort, allowing them to test many approaches at once.

To make sure the right treatments are studied for the right people, patients will be put into different groups, known as 'cohorts'. These groups are based on specific features of your breast cancer, such as whether it's 'triple-negative', 'hormone receptor-positive', or has certain genetic changes like a 'PIK3CA mutation'. Some groups will be for people who haven't had much treatment for their advanced cancer yet, while others are for those whose cancer has continued to grow despite previous treatments. This careful grouping helps researchers tailor the investigations.

Key takeaways

  • This study explores new combinations for advanced breast cancer.
  • It includes various breast cancer types like triple-negative and hormone receptor-positive.
  • Participants will be closely monitored for safety and effectiveness.
  • The study aims to find better ways to treat complex breast cancers.
  • Participation involves different stages and potential treatment changes.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have advanced breast cancer that has either spread or can't be removed by surgery. You'll need to be well enough to take part, meaning you can handle daily activities without too much trouble, and your organs (like your liver and kidneys) should be working properly. Doctors will also need to be able to measure your cancer to see how the treatment is working.

There are also specific requirements depending on which group (cohort) of the study you might fit into. For example, some groups are only for specific types of breast cancer, like triple-negative or HER2-positive, or those with particular genetic changes. You'll need to have a recent tumour sample available for them to test, or be able to have one taken.

However, some things might prevent you from joining. For instance, if you've recently had certain types of immunotherapy or other cancer treatments, or if you're taking strong medications that suppress your immune system, you might not be able to participate. Your study doctor will review all your medical information carefully to see if this study is suitable for 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.

  1. Are you at least 18 years old?
  2. Do you have breast cancer that has spread or is too advanced for surgery?
  3. Are you generally well enough to go about your daily activities?
  4. Are your major organs (like liver, kidneys) working well?
  5. Do you have a recent tumor sample or can one be taken?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first be assigned to one of several treatment groups based on your type of breast cancer and past treatments. You'll then receive a specific combination of medicines. The study is divided into two main stages. In Stage 1, you'll receive your assigned treatment. For some patients, particularly those in one specific group with triple-negative breast cancer, if your cancer progresses or the treatment isn't working well, you might have the option to try a different treatment combination in Stage 2, if that part of the study is open.

Taking part will involve regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. The specific frequency of these visits and tests will depend on the treatment you receive. You'll be given the study drugs, which could be pills or injections. The total duration of your participation will vary depending on how you respond to the treatment and the study's design for your specific group. There will also be follow-up appointments after your treatment period ends.

Potential risks and benefits

Taking part in this study could offer some potential benefits, as you would have access to new treatment combinations that aren't yet widely available. These treatments might help control your cancer, potentially slowing its growth or shrinking it. However, it's also important to be aware of the possible risks. Like all medications, the drugs used in this study can cause side effects, which might be mild or more serious. The study team will carefully monitor you for any side effects and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (45)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope
    Verified postcode
    Duarte, United States· Completed
  • University of California San Diego Medical Center
    Verified postcode
    La Jolla, United States· Completed
  • Stanford Cancer Institute
    Verified postcode
    Stanford, United States· Withdrawn
  • Rocky Mountain Cancer Center - Longmont
    Verified postcode
    Longmont, United States· Completed
  • H. Lee Moffitt Cancer Center and Research Inst.
    Verified postcode
    Tampa, United States· Completed
  • Hackensack Univ Medical Center
    Verified postcode
    Hackensack, United States· Withdrawn
  • Regional Cancer Care Associates, LLC
    Verified postcode
    Howell Township, United States· Withdrawn
  • Rutgers Cancer Institute of New Jersey
    Verified postcode
    New Brunswick, United States· Withdrawn
  • NYU Langone Medical Center
    Verified postcode
    New York, United States· Withdrawn
  • Thomas Jefferson University Hospital
    Verified postcode
    Philadelphia, United States· Withdrawn
  • University of Pittsburgh Medical Center
    Verified postcode
    Pittsburgh, United States· Withdrawn
  • Tennessee Oncology - Chattanooga Oncology & Hematology Associates
    Verified postcode
    Chattanooga, United States· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with advanced breast cancer that has spread (metastatic) or is too advanced for surgery (locally advanced).

What are 'treatment combinations'?

These are different groups of medicines given together to see if they work better than single treatments for cancer.

What does being 'PD-L1 positive' or 'HER2-negative' mean?

These are specific features of your cancer cells that doctors test for. They help decide which treatments might work best for you.

Will I get paid to be in the study?

This information is not provided in the summary. You should ask the study team about any potential costs or reimbursements.

What if the treatment isn't working for me?

For some patients, if the first treatment isn't working or causes too many side effects, there might be an option to try a different combination if specific study conditions are met.

How to find out more

Reference Study ID Number: CO40115 https://forpatients.roche.com/

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study Evaluating the Efficacy and Safety of Multiple Treat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.