RecruitingPHASE3INTERVENTIONAL

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

This study, called RAPID2, is for women with a certain type of early breast cancer. It compares two different radiation treatments given after surgery: radiation to the whole breast (like current standard care) and radiation to just part of the breast. Both treatments are given once a day for about one week. Researchers want to see if treating only part of the breast is just as good at preventing the cancer from coming back in the same breast. They also want to find out if it leads to a better look and feel of the breast (cosmetic outcome) and has fewer unwanted side effects, which will be checked after 3 years. The study involves women aged 50 and older.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrolment target

910

Start

20 Nov 2023

Estimated completion

01 Nov 2031

Breast Neoplasm Female Radiotherapy Cosmetic Outcome

What is this study about?

This study, called RAPID2, is looking at how best to treat women who have been diagnosed with early-stage breast cancer that hasn't spread to other parts of the body. Specifically, it's for women who have had surgery that removed only the lump (called breast-conserving surgery or lumpectomy), and have small tumours that haven't spread to the lymph nodes (glands in the armpit).

The main idea is to compare two ways of giving radiation therapy, which is a common follow-up treatment after lumpectomy. One method, called Whole Breast Irradiation (WBI), treats the entire breast. The other, called Partial Breast Irradiation (PBI), treats only the area where the tumour was. Both treatments will be given over a short period, about one week, with one treatment session each day.

Researchers want to see if partial breast radiation is just as effective as whole breast radiation in stopping the cancer from coming back in the treated breast. They also want to find out if it causes fewer changes to how the breast looks and feels, and generally leads to fewer side effects. The results will be looked at after three years to understand which treatment might offer the best results for patients in the long term.

Key takeaways

This study compares two short-course radiation treatments for early breast cancer.
It aims to see if treating only part of the breast is as effective and has better cosmetic results.
Both treatments involve daily radiation for approximately one week.
Participants will be women aged 50 or older who have had lumpectomy for early breast cancer.
Follow-up will continue for three years after treatment.
You won't know which specific radiation treatment you receive.

Who may be eligible?

This study is looking for women aged 50 or older who have been recently diagnosed with a specific type of early breast cancer. You would need to have had surgery to remove the cancer lump (lumpectomy), and the surgeons must have removed all of the cancer with clear edges around it. The cancer should not have spread to your lymph nodes and the tumour must have been 3cm or less in size.

There are also some reasons why you might not be able to join. For example, if you are under 50, if you are pregnant or breastfeeding, or if you have a known genetic fault like BRCA1 or BRCA2. Also, if you've had certain other cancers recently, or if the breast cancer itself has features that make it different from the type the study is focusing on, you might not be able to take part. This includes certain types of breast cancer or if it's spread to more than one area in the same breast.

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 a woman aged 50 or older?
Have you been diagnosed with early-stage breast cancer that has not spread?
Have you had surgery (lumpectomy) to remove the breast cancer?
Was your tumour 3cm or less in size, and did it not spread to your lymph nodes?
Are you not pregnant, breastfeeding, or known to have certain genetic risks like BRCA1/2?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of two radiation treatments: either whole breast irradiation or partial breast irradiation. You wouldn't know which one you're getting to make sure your feelings about how your breast looks and feels are unbiased. Both treatments involve receiving radiation once a day for about 5 to 7 days, so about one week in total.

Before and after your treatment, you would have regular follow-up appointments where doctors will check how you are doing, monitor for any side effects, and assess how your breast looks and feels. These assessments will continue for 3 years after your treatment starts. The total duration of your active participation, including follow-up, would be 3 years.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new radiation treatment (partial breast radiation) that might have fewer side effects and lead to a better cosmetic outcome than the standard whole breast radiation. However, as with any medical treatment, there are potential risks, including side effects from radiation therapy, which your doctors will discuss with you. You will be monitored closely for any issues. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (29)

GenesisCare Darlinghurst
Verified postcode
Darlinghurst, Australia· Recruiting
GenesisCare Hurstville
Verified postcode
Hurstville, Australia· Recruiting
GenesisCare Mater Hospital
Verified postcode
North Sydney, Australia· Recruiting
GenesisCare Bundaberg
Verified postcode
Bundaberg, Australia· Recruiting
GenesisCare Southport
Verified postcode
Southport, Australia· Recruiting
GenesisCare Tugun
Verified postcode
Tugun, Australia· Recruiting
GenesisCare Hervey Bay
Verified postcode
Urraween, Australia· Recruiting
GenesisCare St Andrew's
Verified postcode
Adelaide, Australia· Recruiting
GenesisCare Bedford Park
Verified postcode
Bedford Park, Australia· Not yet recruiting
GenesisCare Wembley
Verified postcode
Wembley, Australia· Recruiting
GenesisCare Fiona Stanley Hospital
Verified postcode
Murdoch, Australia· Recruiting
GenesisCare Hollywood
Verified postcode
Nedlands, Australia· Recruiting

Common questions

What kind of cancer is this study for?

This study is for women with early-stage breast cancer that has not spread beyond the breast and is no more than 3cm in size, after having had surgery to remove the lump.

What is the difference between the two treatments?

One treatment, Whole Breast Irradiation, treats the entire breast. The other, Partial Breast Irradiation, treats only the specific area where the tumour was.

How long does the radiation treatment last?

Both types of radiation treatment are given once a day for about one week (5-7 days).

Will I know which treatment I am getting?

No, you will not know which treatment you are receiving. This helps make sure your comments about how your breast looks and feels are unbiased.

How long will I be followed in this study?

You will be followed by the study team for 3 years after your radiation treatment.

How to find out more

Shelley Chambers, MA

schamber@mcmaster.ca 905-527-2299 Official trial record

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