Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations (NCT02917421) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
United States88 participantsStarted 2016-12-19
Plain-language summary
This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Who can participate
Age range19 Years – 99 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC.
Inclusion Criteria:
* Age older than 18
* Pre- or post-menopausal women with Stage I-III breast cancer
* Status post neoadjuvant systemic therapy
* Status post-chemotherapy breast surgery
* Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm (patients with focally positive margin are not excluded).
* Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed).
* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Exclusion Criteria:
* Previous radiation therapy to the ipsilateral breast and/or nodal area
* Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
* Pregnant or lactating women
* Concurrent chemotherapy, with the exception of anti HER2neu therapies
* Inadequate axillary dissection in a setting of positive sentinel node
* Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.
What they're measuring
1
Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.
Timeframe: 60 days from start of radiation therapy.
Trial details
NCT IDNCT02917421
SponsorWeill Medical College of Cornell University