88 Participants Needed

Accelerated Radiation for Breast Cancer

(ART Trial)

Recruiting at 2 trial locations
SC
PY
Overseen ByPragya Yadav, Ph.D.
Age: 18+
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: Weill Medical College of Cornell University
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow for anti HER2neu therapies during the study. It's best to discuss your specific medications with the trial team.

Is accelerated radiation therapy safe for breast cancer patients?

Accelerated partial breast irradiation, a form of accelerated radiation therapy, has a very low risk profile and fewer late side effects compared to whole-breast irradiation. Grade 3 late side effects are extremely rare, and most patients experience good cosmetic results.12345

How does Accelerated Radiation Therapy (ART) differ from other breast cancer treatments?

Accelerated Radiation Therapy (ART) for breast cancer is unique because it targets only the area around the tumor site, reducing the treatment time from several weeks to just a few days. This approach, known as accelerated partial breast irradiation, minimizes exposure to healthy tissue and is particularly beneficial for early-stage breast cancer patients.26789

What data supports the effectiveness of the treatment Accelerated Radiation Therapy (ART) for breast cancer?

Research shows that accelerated partial breast irradiation, a form of accelerated radiation therapy, is effective for early-stage breast cancer, offering similar outcomes to whole breast radiation with fewer side effects. Short courses of radiation therapy over 3-4 weeks are generally as effective as longer courses, and modern techniques have improved safety and survival rates.26101112

Who Is on the Research Team?

Silvia Formenti, M.D. | Neurological ...

Silvia Formenti

Principal Investigator

Weill Cornell Medicine - New York Presbyterian Hospital

Are You a Good Fit for This Trial?

This trial is for women over 18 with Stage I-III breast cancer who've had neo-adjuvant chemotherapy and surgery. They must understand the study and agree to participate. Excluded are pregnant or breastfeeding women, those with more than 5 affected lymph nodes, previous radiation in the same area, active connective tissue disorders like lupus, or concurrent chemotherapy (except anti HER2neu therapies).

Inclusion Criteria

Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
I am older than 18 years.
I am a woman with Stage I-III breast cancer, regardless of my menopausal status.
See 4 more

Exclusion Criteria

My lymph node removal was incomplete despite cancer presence.
I am not on chemotherapy, except for HER2-targeted treatments.
Pregnant or lactating women
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy to the breast and nodal stations, including a concomitant boost for some patients

3 weeks
15 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of acute and late radiation toxicity and quality of life

5 years
1 visit at 3 months, then yearly

Long-term Monitoring

Molecular signatures predicting fibrosis are measured from blood samples

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated Radiation Therapy (ART)
Trial Overview The trial tests Accelerated Radiation Therapy (ART) on patients after breast cancer surgery. It aims to see if ART can effectively treat breast cancer by targeting the remaining breast tissue and nearby lymph node areas post-surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy) Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Group II: Cohort 1Experimental Treatment1 Intervention
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost. Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Published Research Related to This Trial

Radiation therapy is crucial in breast cancer treatment, significantly reducing local recurrence and improving survival rates, especially with advancements in techniques since the late 1980s.
Shorter courses of radiation therapy (3-4 weeks) are generally as effective as longer ones, and modern techniques like volumetric modulated arc therapy (VMAT) help minimize complications while enhancing treatment outcomes.
Evolution of radiotherapy techniques in breast conservation treatment.Boyages, J., Baker, L.[2020]
In a study of 200 breast cancer patients, those receiving accelerated radiotherapy in 5 fractions experienced significantly lower acute toxicity compared to those receiving treatment in 15 fractions, with notable reductions in breast pain, fatigue, edema, and dermatitis.
Patients treated with the 5-fraction schedule reported better health-related quality of life, including improved physical well-being and less deterioration in social functioning, indicating that this treatment approach may enhance patient comfort and overall experience during therapy.
Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost.Van Hulle, H., Vakaet, V., Monten, C., et al.[2022]

Citations

Accelerated Partial Breast Irradiation: Technological Advances and Current Challenges. [2023]
Early-stage breast cancer treated with 3-week accelerated whole-breast radiation therapy and concomitant boost. [2018]
Updated ASTRO guidelines on accelerated partial breast irradiation (APBI): to whom can we offer APBI outside a clinical trial? [2023]
4.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Evolution of radiotherapy techniques in breast conservation treatment. [2020]
Leveraging intelligent optimization for automated, cardiac-sparing accelerated partial breast treatment planning. [2023]
Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost. [2022]
Breast brachytherapy. [2021]
Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. [2022]
Long-term outcome and toxicity in a Phase I/II trial using high-dose-rate multicatheter interstitial brachytherapy for T1/T2 breast cancer. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
A comparison of brachytherapy techniques for partial breast irradiation. [2012]
[Conformal accelerated partial breast irradiation: state of the art]. [2018]
Early outcomes data for accelerated partial breast irradiation using balloon brachytherapy. [2011]
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