Accelerated Radiation Therapy for Breast Cancer
(PRART Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen bySilvia Formenti, M.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Previous radiation, Male breast cancer, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Accelerated Radiation Therapy for Breast Cancer?
Research shows that accelerated partial breast irradiation (APBI), a component of the treatment, can be as effective as whole-breast irradiation for early-stage breast cancer, with studies indicating comparable local control and potential for increased survival in resource-constrained settings.
12345Is accelerated radiation therapy for breast cancer safe for humans?
Research shows that accelerated radiation therapy, including methods like accelerated partial breast irradiation (APBI) and three-dimensional conformal radiotherapy (3D-CRT), is generally safe for humans, with studies focusing on both acute (short-term) and late (long-term) side effects. These treatments have been evaluated for early-stage breast cancer and have shown manageable levels of normal tissue toxicity.
13678How is accelerated radiation therapy for breast cancer different from other treatments?
Accelerated radiation therapy for breast cancer is unique because it shortens the treatment time to just three weeks, compared to the traditional six-week course. This approach, known as accelerated partial breast irradiation (APBI), targets only the area around the lumpectomy site, potentially reducing side effects and making it more convenient for patients.
1591011Eligibility Criteria
This trial is for women who've had a specific breast surgery for early-stage cancer (Stage 0, T1-T2) with no cancer left at the edges of removed tissue and no spread to lymph nodes. It's not open to men, those treated within 60 days after chemotherapy or 90 days post-surgery if they received chemo, or anyone previously radiated on the same breast.Inclusion Criteria
I have had a segment of my breast surgically removed.
My breast cancer was removed with clear margins.
My breast cancer is contained and hasn't spread beyond its original site.
+2 more
Exclusion Criteria
It has been over 60 days since my last chemotherapy session.
It's been over 90 days since my last surgery, or I've had chemotherapy after surgery.
I am a male diagnosed with breast cancer.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1) or 10 fractions (Arm 2)
2-3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The study compares two schedules of radiation therapy after breast surgery: one group receives standard treatment over three weeks while another gets an experimental shorter course over two weeks. Both groups also get extra radiation focused on where the tumor was.
2Treatment groups
Experimental Treatment
Group I: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractionsExperimental Treatment1 Intervention
Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.
Group II: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractionsExperimental Treatment1 Intervention
Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions
Radiation therapy - 3 weeks is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Radiation therapy for:
- Breast cancer
- Ductal carcinoma in situ (DCIS)
- Early-stage breast cancer
🇺🇸 Approved in United States as Radiation therapy for:
- Breast cancer
- Ductal carcinoma in situ (DCIS)
- Early-stage breast cancer
- Locally advanced breast cancer
🇨🇦 Approved in Canada as Radiation therapy for:
- Breast cancer
- Ductal carcinoma in situ (DCIS)
- Early-stage breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York Presbyterian Hospital - QueensNew York, NY
New York Presbyterian Hospital at Lower Manhattan Cancer CenterNew York, NY
Brooklyn Methodist Hospital - NewYork PresbyterianNew York, NY
Loading ...
Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. [2018]Accelerated partial breast irradiation (APBI) is emerging as an alternative to whole-breast irradiation. This study presents the results of a prospective trial evaluating 3-dimensional conformal radiotherapy (3D-CRT) to deliver APBI for early-stage breast cancer.
Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. [2021]To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer.
Nation-Scale Adoption of Shorter Breast Radiation Therapy Schedules Can Increase Survival in Resource Constrained Economies: Results From a Markov Chain Analysis. [2018]Hypofractionated whole breast irradiation and accelerated partial breast irradiation (APBI) offer women options for shorter courses of breast radiation therapy. The impact of these shorter schedules on the breast cancer populations of emerging economies with limited radiation therapy resources is unknown. We hypothesized that adoption of these schedules would improve throughput in the system and, by allowing more women access to life-saving treatments, improve patient survival within the system.
Accelerated partial breast irradiation: an advanced form of hypofractionation. [2019]Altered fractionation schedules are being increasingly investigated in the treatment of breast cancer. Two such schedules that are frequently compared are hypofractionated external beam radiation therapy (HERT) and accelerated partial breast irradiation (APBI). Though these two modalities are considered separately, APBI is an actually an advanced form of hypofractionation, where acceleration of the treatment is possible due to the smaller volume being irradiated. HERT as well as APBI are investigational at present and are being tested in randomized trials. This article looks at the advantages of APBI as a hypofractionation schedule.
Accelerated partial breast irradiation: where do we stand? [2019]Accelerated partial breast irradiation (APBI) is a new form of postlumpectomy radiotherapy delivered over 1 to 5 days. Early trials showed high local recurrence rates. More recent single and multiinstitutional studies, as well as a single phase III trial, have shown local control more comparable to whole breast radiotherapy. Patient selection and surgical technique are important variables preparatory to irradiation, which is delivered using 1 of 4 accelerated radiotherapy methods. Phase I/II studies have produced most of the information currently available regarding APBI. Additional phase III studies are underway to determine whether any or all of these accelerated radiotherapy approaches may safely substitute for whole breast radiotherapy in women seeking breast conservation.
The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen. [2022]The use of external beam accelerated partial breast irradiation (APBI) using a twice-per-day regimen has raised concerns about increase rates of late toxicities. We compared toxicity outcomes of external beam APBI using a once-per-day regimen and accelerated hypofractionated whole breast irradiation (AWBI) in patients with early-stage breast cancer.
Feasibility and acute toxicity of 3-dimensional conformal external-beam accelerated partial-breast irradiation for early-stage breast cancer after breast-conserving surgery in Chinese female patients. [2022]A growing number of studies worldwide have advocated the replacement of whole-breast irradiation with accelerated partial breast irradiation using three-dimensional conformal external-beam radiation (APBI-3DCRT) for early-stage breast cancer. But APBI can be only used in selected population of patients with early-staged breast cancer. It is not replacing the whole breast radiotherapy. This study aimed to examine the feasibility and acute normal tissue toxicity of the APBI-3DCRT technique in Chinese female patients who generally have smaller breasts compared to their Western counterparts.
Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. [2021]The aim of this study was to report the 5-year results of accelerated partial breast irradiation (APBI) using external beam three-dimensional conformal radiotherapy (3D-CRT).
Comparison Of Accelerated Partial Breast Radiation Therapy And External Beam Radiation Therapy By Treatment Planning Indices. [2022]Accelerated partial breast irradiation (APBI) is a method in which just bed of lumpectomy with a margin of 1-2 cm is irradiated. Regarding advantages of APBI to whole-brain radiation therapy (WBRT) and limitations for performing other techniques, we compare external beam radiation therapy (EBRT) with three-dimensional conformal radiation therapy (3DCRT), as a type of APBI technique.
Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. [2007]Several accelerated partial-breast irradiation (APBI) techniques are being investigated in patients with early-stage breast cancer. We present our initial experience using three-dimensional conformal radiation therapy (3D-CRT).
Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]Logistical barriers of time and travel created by the conventional six-week course of radiotherapy prevent many women from pursuing breast conservation treatment. For the past 12 years, Accelerated Partial Breast Irradiation (APBI) has been investigated as a potential alternative treatment approach in women with early stage breast cancer. The ability to complete treatment in five days has the potential to provide additional women with the option of breast conservation. The validity of this APBI is supported in the study of in-breast recurrence patterns, pathologic data and the clinical treatment experience. The review of the recent data on contemporary APBI reveals that patient selection criteria and brachytherapy quality assurance are clearly critical components and necessary to assure a successful treatment outcome. This updated report from the American Brachytherapy Society on Accelerated Partial Breast Irradiation reviews the appropriate background data supporting this treatment approach with conclusions regarding patient selection criteria and treatment delivery.