Active not recruitingPHASE3INTERVENTIONAL

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

This research study is looking at an updated way to give radiation therapy after a mastectomy for certain types of stage 2 or 3 breast cancer. It's designed for people who have had their breast removed. The study wants to find out if a shorter course of radiation, called 'hypofractionated' therapy, which gives higher doses in fewer sessions, works as well as the usual, longer radiation course. Researchers also want to see if this new approach might cause fewer side effects, especially for those who have had breast reconstruction. The main goal is to prevent the cancer from returning while improving the patient's experience and quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Enrolment target

898

Start

12 Mar 2018

Estimated completion

01 Aug 2035

Ductal Breast Carcinoma Invasive Breast Carcinoma Lobular Breast Carcinoma Medullary Breast Carcinoma Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Tubular Breast Carcinoma

Results

Results from this study

Posted February 2026

Results have been published for this study.

Primary outcome

Proportion of Breast Reconstruction Complications

The primary endpoint of this trial is the rate of ipsilateral breast reconstruction complications defined (in the protocol in 10.0. Measurement of effect) as; Capsular contracture (Baker Grade III or IV only), Complete failure of the implant/skin flap, Unplanned admission for reconstruction related issue(s) including but not limited to infection, wound healing complication or pain, Unplanned return to the operating room for recon related issue including but not limited to infection, prosthesis exposure, failed reconstruction, implant removal, wound healing complications or contracture management. Note: Routine revisions such as dog-ear corrections, fat grafting, and contralateral breast revision will be recorded, but not counted towards the primary endpoint; ii) Complications related to the contralateral breast will be collected but will not count towards the assessment of the primary endpoint, ipsilateral breast complications will be counted towards the primary endpoint.

Full results on the registry

What is this study about?

This research study is looking for women who have had a mastectomy (surgery to remove the breast) for specific types of stage 2 or 3 breast cancer. The main aim is to compare two different ways of giving radiation therapy, which is treatment using high-energy rays to kill any remaining cancer cells.

One type is the standard radiation care you might already know about. The other is called 'hypofractionated' radiation therapy. This means you get higher doses of radiation in each session, which allows for fewer total treatment sessions. Doctors hope this shorter treatment could be just as effective at stopping cancer from coming back, with potentially fewer side effects. This could make treatment more convenient and comfortable for patients.

Throughout the study, doctors will be carefully watching to see how well both types of radiation work, if one causes more or fewer side effects, and how they affect breast reconstruction results and your overall well-being. They'll also look at things like your happiness with your new breast, your physical comfort, and even the cost of treatment.

Key takeaways

Compares two radiation treatments after mastectomy for breast cancer.
Aims to see if a shorter radiation course is as effective and has fewer side effects.
Will assess impact on breast reconstruction and quality of life.
Participation involves questionnaires and follow-up for 2 years.
You'll be randomly assigned to either standard or shorter radiation treatment.

Who may be eligible?

To join this study, you need to be an adult (18 or older) and have been diagnosed with certain types of stage 2 or 3 breast cancer, such as ductal, lobular, tubular, or medullary breast cancer. You must have already had a mastectomy (breast removal surgery).

It's important that you haven't received radiation therapy to your chest, neck, or armpit before. You also shouldn't have had breast cancer in the same breast before, or invasive breast cancer in the other breast. Conditions like lupus or scleroderma would also prevent you from joining. The edges of the tissue removed during your mastectomy must also be clear of invasive cancer cells.

The study team will carefully check your medical records, including your cancer stage and any other health conditions, to make sure this study is the right fit for you. Even if you don't fit every single detail, it's always worth discussing with your doctor if a study might be an option.

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 18 years old or older?
Have you recently had a mastectomy for stage 2 or 3 breast cancer (not metaplastic type)?
Have you NEVER had radiation therapy to your chest, neck, or armpit before?
Do you NOT have connective tissue diseases like lupus or scleroderma?
Are the edges of your mastectomy surgery clear of invasive cancer cells?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive one of two types of radiation therapy after your mastectomy: either the standard treatment or the shorter, hypofractionated treatment. This is like flipping a coin, so neither you nor your doctor can choose which one you'll get.

Throughout the study, you'll have regular appointments where doctors will check for any side effects and how your body is responding. You'll also be asked to fill out questionnaires about your quality of life, how you're feeling, and your satisfaction with your breast reconstruction. Some visits might involve having pictures taken of your breasts or providing blood samples for further analysis. The study will continue for a total of 24 months after your radiation therapy is finished, with follow-up appointments and assessments over this period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the new, shorter radiation therapy might be just as effective as the standard treatment but with fewer side effects and greater convenience. However, it's also possible that the new treatment might have different or unexpected side effects. You might also not receive any direct personal benefit from participating, but the information gained could help others in the future. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (859)

Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Anchorage Radiation Therapy Center
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
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
Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States
Kingman Regional Medical Center
Verified postcode
Kingman, United States
Cancer Center at Saint Joseph's
Verified postcode
Phoenix, United States
Mercy Hospital Fort Smith
Verified postcode
Fort Smith, United States

Common questions

What is 'hypofractionated' radiation therapy?

It's a type of radiation treatment where you get slightly higher doses in each session, meaning you need fewer sessions overall, making the treatment course shorter.

Why is this study being done?

To see if the shorter radiation treatment is as good as the standard one at preventing cancer from coming back after a mastectomy, and if it leads to fewer side effects, especially with breast reconstruction.

Will I get to choose which radiation treatment I receive?

No, you will be randomly assigned to either the standard radiation or the shorter, hypofractionated treatment. This is to ensure fair comparison between the two groups.

What kind of breast cancer is this study for?

It's for certain types of stage 2 or 3 breast cancer, like ductal, lobular, medullary, or tubular, after you've had a mastectomy.

How long will I be involved in the study?

The study will follow up with you for 24 months (two years) after your radiation therapy is completed.