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Evaluation of Radiotherapy after Complete Response to Neoadjuvant Chemotherapy in HER-2 Positive Breast Cancer Patients
Proposal
6078
Title of Proposed Research
Evaluation of Radiotherapy after Complete Response to Neoadjuvant Chemotherapy in HER-2 Positive Breast Cancer Patients
Lead Researcher
Youssef Zeidan
Affiliation
American University of Beirut, Medical Center
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
16 Oct 2019
Lay Summary
Although treatment modalities of breast cancer are continuously evolving, evidence for the best treatment combination is still lacking in specific sets of patients. Administration of radiotherapy for HER-2 positive breast cancer patients that have received neoadjuvant targeted therapy/chemotherapy and achieved complete pathological response remains controversial in some clinical scenarios. This creates a clinical dilemma that has to balance the toxicities of radiation against its ability to eradicate probable occult malignant cells that can increase the risk of locoregional recurrence and decrease overall survival rates.
Study Data Provided
[{ "PostingID": 4335, "Title": "ROCHE-WO20697", "Description": "A randomized, open label study to compare the complete pathological response rate achieved with 4 combinations of Herceptin, docetaxel and pertuzumab in patients with locally advanced, inflammatory or early stage HER2 positive breast cancer" },{ "PostingID": 4436, "Title": "NOVARTIS-LPT109096", "Description": "Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women with ErbB2- (HER2/neu-) Overexpressing Invasive Breast Cancer" },{ "PostingID": 14471, "Title": "ROCHE-BO22280", "Description": "A randomized study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy or concomitantly with a non-anthracycline based chemotherapy, as neoadjuvant therapy for patients with HER2-positive breast cancer." }]
Statistical Analysis Plan
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