Accelerated Radiation for Breast Cancer

(ART Trial)

Not currently recruiting at 2 trial locations

Overseen By Pragya Yadav, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Flare therapy

Disqualifiers: Previous radiation, Connective tissue disorders, Pregnant, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for individuals with breast cancer who recently underwent surgery and chemotherapy. The goal is to determine if a shorter, more intense radiation schedule is safe and effective. Participants are divided into two groups: one receives radiation to the breast or chest area, while the other receives additional radiation to nearby lymph nodes. The trial seeks women with Stage I-III breast cancer who have had surgery and chemotherapy, with cancer removed with clear margins (no cancer at the edge of the tissue removed). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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.

What prior data suggests that this protocol is safe for breast cancer patients?

Research has shown that accelerated radiation therapy (ART) for breast cancer is generally safe and well-tolerated. One study found that only 14% of patients experienced complications with the shorter radiation course, compared to 12% with the longer course. Another study reported no severe side effects, with skin irritation decreasing significantly over time, from 71.7% at the end of treatment to just 5.4% six months later. Additionally, ART is associated with fewer long-term side effects compared to traditional methods. These findings suggest that ART could be a safe option for breast cancer patients, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Accelerated Radiation Therapy (ART) for breast cancer because it streamlines the treatment process, potentially offering the same effectiveness as traditional radiation but in a shorter time frame. Unlike conventional radiation therapy, which typically requires daily sessions over several weeks, ART compresses the treatment into just 15 sessions. This accelerated schedule is not only convenient for patients but may also reduce the overall burden of cancer treatment on their daily lives. Additionally, ART targets both the original tumor bed and, in some cases, nearby lymph nodes, providing a comprehensive approach to treatment.

What evidence suggests that Accelerated Radiation Therapy could be an effective treatment for breast cancer?

Research has shown that accelerated radiation therapy (ART) can be as effective as standard radiation therapy in preventing breast cancer recurrence. Studies have found both ART and standard treatments similarly reduce the risk of cancer returning. Patients receiving ART typically experience side effects similar to those of traditional treatments. ART is administered on a shorter schedule, offering more convenience without losing effectiveness. In this trial, participants in Cohort 1 will receive ART to the whole breast or chest wall, while those in Cohort 2 will also receive radiation to Level III axillary nodes and supraclavicular nodes. Some studies have reported that the appearance of the treated area is good, with many patients satisfied with the results. Overall, ART is a promising option for breast cancer patients requiring radiation after surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

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

I am older than 18 years.

Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

I am a woman with Stage I-III breast cancer, regardless of my menopausal status.

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

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?

Group I: Cohort 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6378667/

Effectiveness of different accelerated partial breast ... Based on indirect comparisons, no differences in clinical outcomes were observed among diverse APBI techniques in published clinical trials that formally ...

2. moffitt.org moffitt.org/endeavor/archive/accelerated-radiation-as-effective-as-standard-therapy-for-certain-breast-cancer-patients/

Accelerated Radiation as Effective as Standard Therapy for ... Results showed accelerated and standard courses of treatment were both equally effective at preventing cancer recurrence. Side effects were also ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10885562/

Five-Year Outcomes of a Phase 1/2 Trial of Accelerated Partial ... 2. The cosmesis at baseline before radiation was excellent in 56% (23 breasts) and good in 44% (18 breasts). At 2 years, the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02917421

Accelerated Radiation Therapy (ART) to the Breast and ... This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... We conducted a study to determine whether a hypofractionated 3-week schedule of whole-breast irradiation is as effective as a 5-week schedule.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7136642/

Comparison of Toxicity and Cosmetic Outcomes After ... Conclusions. In women with breast cancer after BCS, APBI was associated with better cosmetic outcome and fewer late radiation toxicities than WBI.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8800131/

Safety of pre- or postoperative accelerated radiotherapy in ... Neo-adjuvant radiotherapy (NART) for breast cancer has shown promising survival results in retrospective trials.

8. moffitt.org moffitt.org/endeavor/archive/new-study-confirms-shorter-radiation-therapy-safe-for-breast-cancer-patients-undergoing-reconstruction/

New Study Confirms Shorter Radiation Therapy Safe for ... In the study, only 14% of patients who received the shorter course of radiation experienced complications, compared to 12% in the longer group.

9. nature.com nature.com/articles/s41598-024-73627-x

A systematic review on the techniques, long-term outcomes ... To evaluate the efficacy and safety of four techniques of partial breast irradiation (PBI) including interstitial brachytherapy (ISBT), ...

10. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(24)00258-9/fulltext

Feasibility and Safety of the “One-Week Breast Radiation ... The rate of radio-dermatitis decreased from end-RT to 6 months (71.7% vs 5.4%, P< 0.001). No patient experienced grade ≥3 toxicity. At 6 months, ...