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This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.
A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.
The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemotherapy arm | No Intervention | The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines. post systemic treatment imaging will be done to assess the response, followed by surgery as indicated. Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated. Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics. | |
| Neoadjuvant chemoradiation arm | Experimental | The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemoradiation | Radiation | Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response rates | the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system | 1 week postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| acute radiation toxicity | radiation therapy oncology group (RTOG) acute morbidity score | during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks |
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Inclusion Criteria:
Female patients.
Age: 21 years or older.
ECOG performance status (PS) score 0 to 2.
Locally advanced tumors (stage IIIA or above) of any subtype.
Early breast cancer of the HER2+ or TNBC subtype when:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medhat El Sebaie, Professor | National Cancer Institute (NCI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39106546 | Background | Ward J, Ho K, Ike C, Wood SH, Thiruchelvam PTR, Khan AA, Leff DR. Pre-operative chemoradiotherapy followed by mastectomy and breast reconstruction-A systematic review of clinical, oncological, reconstructive and aesthetic outcomes. J Plast Reconstr Aesthet Surg. 2024 Sep;96:242-253. doi: 10.1016/j.bjps.2024.07.022. Epub 2024 Jul 15. | |
| 29948462 |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| O' Halloran N, McVeigh T, Martin J, Keane M, Lowery A, Kerin M. Neoadjuvant chemoradiation and breast reconstruction: the potential for improved outcomes in the treatment of breast cancer. Ir J Med Sci. 2019 Feb;188(1):75-83. doi: 10.1007/s11845-018-1846-6. Epub 2018 Jun 14. |