Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
Breast Cancer
Спонсор: Weill Medical College of Cornell University
Налично на:
БГ
Обобщение
This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Описание
Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. 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 (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.
Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes.
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).
Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.
Кой може да участва
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.