RecruitingNAINTERVENTIONAL

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

This study, called PRESERVE, investigates a new way to deliver radiation therapy for women who have had breast cancer return, or developed a new cancer in the same breast after previous treatment. Typically, this might involve removing the whole breast or longer radiation courses, which can be tough. This new approach uses a special type of radiation called ‘partial breast re-irradiation’ (rPBI), which targets only the affected area. What’s new is that it uses a very short, one-week (five-treatment) schedule. The study wants to check if this shorter, more convenient treatment is safe and has acceptable side effects for women who have had a second surgery to remove the cancer, rather than a full mastectomy.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

171

Start

27 Jun 2023

Estimated completion

27 Jun 2027

Breast Cancer Breast Cancer Recurrent

What is this study about?

For many women with breast cancer, an operation to remove the tumour is followed by radiation therapy to help stop the cancer from coming back. Unfortunately, sometimes the cancer can return in the same breast, even after previous treatment. When this happens, doctors usually discuss options like removing the whole breast (mastectomy) or having a long course of radiation. These treatments can be difficult and sometimes lead to side effects or negatively impact a woman's well-being.

This study is looking at a new type of radiation treatment called ‘partial breast re-irradiation’ (rPBI). This method is designed to treat only the specific area where the cancer has returned, rather than the whole breast. This can mean fewer side effects and better cosmetic results compared to treating the entire breast again. What's particularly new and convenient about this study is that it explores a very short radiation schedule – just one week of treatment (five sessions in total) – after a second operation to remove the cancer. This is much quicker than traditional radiation courses, which can last several weeks.

The main aim of this study is to find out if this shorter, one-week course of rPBI is safe for women who have had a second breast-conserving surgery (a lumpectomy) for a returning cancer or a new cancer in the same breast, after having radiation before. Researchers will be carefully monitoring participants for any side effects over the first year to make sure this new treatment approach is acceptable. If it proves safe and effective, it could offer a much more convenient and less disruptive treatment option for many women.

Key takeaways

You could receive a new, shorter radiation treatment for recurring breast cancer.
The radiation treatment would be completed in just one week (5 sessions).
This study aims to find out how safe and well-tolerated this shorter treatment is.
It's for women who've had breast cancer return in a previously treated breast and had a second surgery.
The treatment focuses only on the affected area of the breast, not the whole breast.
Regular check-ups will monitor your health and recovery.

Who may be eligible?

This study is looking for women aged 18 or older who have had breast cancer return in the same breast, or have developed a new breast cancer in a breast that has been treated with radiation before. The tumour must be relatively small (less than 3cm) and must have been completely removed during a second operation (meaning no cancer cells were found at the edges of the removed tissue). It's also important that at least five years have passed since your previous radiation treatment to your breast.

You should not be pregnant or breastfeeding. You won't be able to join if your cancer has spread to other parts of your body or to your lymph nodes. Additionally, if you have other serious health problems, such as certain heart or lung conditions, or if you have specific types of breast implants or pacemakers, this study might not be suitable for you.

Finally, the study requires that the radiation treatment can start within 16 weeks of your last breast operation or within 12 weeks of your last chemotherapy cycle, if you had it. Doctors also need to be clearly able to identify the area that needs to be treated with radiation; sometimes after complex breast surgeries, this can be difficult.

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 aged 18 or over?
Has your breast cancer returned, or do you have a new cancer, in a breast that has been previously treated with radiation?
Is the new cancer relatively small (under 3cm) and has it been completely removed by surgery?
Has it been at least 5 years since your last breast radiation treatment?
Are you currently not pregnant or breastfeeding?
Has your cancer not spread to your lymph nodes or other parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a specific type of radiation therapy called ‘external beam rPBI’. This involves five daily radiation sessions over one week. These sessions usually involve lying on a treatment bed while a machine delivers radiation to the specific area of your breast. You will have had an operation to remove the cancer before starting the radiation.

During the study, you will have regular check-ups to monitor your health and any potential side effects. These will likely include appointments with your doctor and possibly scans or tests to see how you are recovering and if the treatment has been effective. The main focus will be on monitoring side effects for up to a year after the radiation treatment. The total duration of your active participation, including check-ups, will depend on the study's follow-up schedule, but the radiation treatment itself is completed within one week.

Potential risks and benefits

One potential benefit of this study is that you might receive a shorter, more convenient radiation treatment over just one week, which could mean less disruption to your daily life. This type of targeted radiation (rPBI) is also often associated with fewer side effects and better cosmetic results than treating the whole breast. However, as with any medical treatment, there are potential risks, including side effects from the radiation, such as skin irritation, changes to the breast tissue, or feeling tired. While this specific treatment is being studied for its safety, there's always a possibility of unexpected reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (19)

NYU Langone Health
Verified postcode
New York, United States· Recruiting
Columbia University Medical Center
Verified postcode
New York, United States· Recruiting
Virgina Community University Massey Comprehensive Cancer Center
Verified postcode
Richmond, United States· Recruiting
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
A.C.Camargo Cancer Center
Verified postcode
São Paulo, Brazil· Recruiting
Royal Victoria Regional Health Centre
Verified postcode
Barrie, Canada· Recruiting
London Health Science Centre - Verspeeten Family Cancer Centre
Verified postcode
London, Canada· Recruiting
Lakeridge Health
Verified postcode
Oshawa, Canada· Recruiting
Odette Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
CHU de Québec-Université Laval
Verified postcode
Montreal, Canada· Recruiting
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is 'rPBI'?

rPBI stands for 're-irradiation with partial breast irradiation'. It's a type of radiation treatment that focuses only on the part of the breast where the cancer has returned, rather than the whole breast.

What does a 'one-week ultra-hypofractionated' treatment mean?

This means you would receive your radiation treatment in just five sessions, one each day, for a single week. It's a much shorter course of treatment compared to traditional radiation that can last several weeks.

Is this treatment proven to work?

This study is investigating if this particular one-week treatment schedule is safe and has acceptable side effects. While similar treatments have shown promise, this specific short schedule used in re-irradiation is still being studied.

Will I still need surgery if I join this study?

Yes, this study is for women who have already had a second surgery (like a lumpectomy) to remove the returning cancerous tissue before starting the radiation treatment.

What kind of side effects might I expect?

The study aims to see if this treatment causes acceptable side effects, but some common ones after radiation can include skin redness, soreness, or changes in the breast tissue. Your care team will monitor you closely.

How to find out more

Danielle Rodin, MD

danielle.rodin@uhn.ca (416) 946-6513 Official trial record

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