Active not recruitingPHASE2INTERVENTIONAL

Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

This research trial is investigating inflammatory breast cancer, a rare and aggressive type of breast cancer. The main goal is to see if combining a drug called olaparib with standard radiation therapy is more effective than radiation therapy alone. Radiation therapy uses high-energy X-rays to destroy cancer cells. Olaparib is a type of targeted drug that works by blocking an enzyme cancer cells use to fix their genetic material (DNA). By stopping this repair process, olaparib aims to make cancer cells more vulnerable and cause them to die. The study is particularly interested in whether this combination helps stop the cancer from coming back or spreading, and if it improves overall survival for patients. This is a Phase II study, meaning it's still an earlier stage of research.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

300

Start

18 Jan 2019

Estimated completion

01 Jun 2027

Breast Inflammatory Carcinoma

What is this study about?

This study is about inflammatory breast cancer, which is a less common but often aggressive form of breast cancer. Doctors are trying to find the best ways to treat it and prevent it from coming back. In this trial, they are focusing on a treatment approach that combines standard radiation therapy with a newer drug called olaparib.

Radiation therapy is a well-known cancer treatment that uses powerful X-rays to target and kill cancer cells, or to stop them from growing. Olaparib is a type of 'targeted therapy'. This means it's designed to attack specific weaknesses in cancer cells. In this case, olaparib blocks a protein called PARP, which cancer cells use to fix their DNA when it gets damaged. By stopping this repair, the cancer cells can't fix themselves and are more likely to die. The idea is that using olaparib alongside radiation therapy might make the radiation more effective, because the cancer cells will have a tougher time recovering from the radiation damage.

The main aim of this study is to compare patients who receive radiation therapy plus olaparib versus those who receive radiation therapy alone. The researchers want to see if the group receiving olaparib has a better chance of staying cancer-free for longer, especially in the treated area, and whether it helps them live longer overall. They will also collect tissue and blood to learn more about inflammatory breast cancer for future research.

Key takeaways

This study is testing a new combination treatment for inflammatory breast cancer.
It combines standard radiation with a drug called olaparib.
Olaparib works by stopping cancer cells from repairing themselves.
The aim is to see if this combination improves long-term outcomes.
Participation involves daily medication (if assigned) and regular follow-up for up to 8 years.
This is an important Phase II study, early research that looks at how well the treatment works.

Who may be eligible?

To be part of this study, you must have been diagnosed with inflammatory breast cancer that has not spread to other parts of your body. You should have already finished chemotherapy and had surgery (a mastectomy), with clear surgical edges and no obvious remaining cancer. Your surgery must have happened between 3 and 12 weeks before you join the study. If you had extra chemotherapy after your mastectomy, you also need to meet certain timing requirements.

It's important that you haven't received radiation therapy to your chest or armpit area before. Your care team will check your specific cancer details, like certain markers (ER, PR, HER2), but all types of inflammatory breast cancer are generally welcome. You'll need to be at least 18 years old to take part.

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.

I have inflammatory breast cancer without spread to distant parts of my body.
I have completed chemotherapy and had a mastectomy for my cancer.
My mastectomy was between 3 and 12 weeks ago (or adjusted for extra chemotherapy).
I have not had radiation therapy to my chest or armpit area before.
I am at least 18 years old.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive standard radiation therapy only. The other group will receive standard radiation therapy along with the study drug, olaparib.

If you're in the olaparib group, you'll take the medication by mouth, twice a day, starting the day before your radiation therapy begins and continuing throughout the entire 6 weeks of radiation, including weekends. Both groups will have radiation therapy 5 days a week for 6 weeks, as long as it's not causing too many side effects or if your condition changes. You’ll also provide blood samples at various times during the study. After your treatment finishes, you'll have follow-up appointments, first every 3 months for three years, and then every 6 months for up to 8 years in total, to check on your health and ensure the cancer hasn't returned.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of this study is that adding olaparib to radiation therapy *might* be a more effective treatment for inflammatory breast cancer, possibly leading to a longer period without the cancer returning or a longer life. However, this is not guaranteed, and you might not personally benefit. Potential risks include side effects from both radiation therapy and olaparib, which your care team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (220)

Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Anchorage Oncology Centre
Verified postcode
Anchorage, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
University of Arizona Cancer Center-Orange Grove Campus
Verified postcode
Tucson, United States
University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Verified postcode
Jonesboro, United States
Alta Bates Summit Medical Center-Herrick Campus
Verified postcode
Berkeley, United States
Epic Care Partners in Cancer Care
Verified postcode
Emeryville, United States
Los Angeles General Medical Center
Verified postcode
Los Angeles, United States

Common questions

What is inflammatory breast cancer?

It's a rare and aggressive type of breast cancer where cancer cells block lymph vessels in the skin, causing the breast to look red, swollen, and inflamed.

What is targeted therapy?

Targeted therapy are drugs that specifically attack cells with certain weaknesses, helping spare healthy cells more than traditional chemotherapy.

What does 'randomised' mean?

It means you'll be assigned to one of the study groups by chance, like drawing straws or flipping a coin. Neither you nor your doctor chooses the group.

Will I know which group I'm in?

Yes, for this study, you will know if you are receiving olaparib or not, as it's not a 'blinded' study.

How long will I be followed after treatment?

You will be followed for up to 8 years, with appointments becoming less frequent over time, to monitor your health.