Accelerated Radiation for Breast Cancer
(ART Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

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

Overseen bySilvia Formenti

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

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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

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Treatment Details

Interventions

Accelerated Radiation Therapy (ART) (Radiation Therapy)

Trial OverviewThe 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.

Participant Groups

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.