Avoiding surgery in breast cancer patients with exceptional Response to neo-adjuvant chemotherapy - ASTARTE Trial
Association of Breast Surgery ePoster Library. Tasoulis M. 05/13/19; 257166; P124
Mr. Marios Konstantinos Tasoulis
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P124
Topic: Other
Background: Neoadjuvant chemotherapy (NACT) is increasingly used in phenotype-appropriate, early-stage breast cancer. Modern chemotherapy regimens and the use of targeted therapies can eliminate gross disease in increasing number of women. Particularly in triple negative (TN) and HER2-positive subtypes, pathologic complete response (pCR) rates exceeding 60% have been reported. In these cases, the role of surgery is limited to histopathological confirmation of pCR. Recent data suggest that in selected women with exceptional clinical and imaging response, post-NACT, pre-surgery large volume, vacuum-assisted core biopsy (VACB) of the imaging residuum can reliably identify those who achieve pCR and therefore may not benefit from surgery. ASTARTE is a pilot study aiming to evaluate the safety of omission of surgery in a selected group of women with exceptional response to NACT. Methods : Fifty women with unifocal, T1-2, N0, M0, TN or HER2-positive invasive ductal carcinoma of the breast will be entered in the study. To be eligible, women must have completed standard NACT and achieved a complete or near complete imaging response on ultrasound scan +/- mammogram. They must have also demonstrated a pCR on post-NACT VACB following a standardized protocol. These women will not undergo breast and axillary surgery following completion of NACT but will receive radiotherapy and will continue systemic treatments as indicated. The primary endpoint of the study is the biopsy proven ipsilateral breast tumour recurrence free survival at 5 years. Results will provide data that might support a paradigm change in the treatment of breast cancer.
Topic: Other
Background: Neoadjuvant chemotherapy (NACT) is increasingly used in phenotype-appropriate, early-stage breast cancer. Modern chemotherapy regimens and the use of targeted therapies can eliminate gross disease in increasing number of women. Particularly in triple negative (TN) and HER2-positive subtypes, pathologic complete response (pCR) rates exceeding 60% have been reported. In these cases, the role of surgery is limited to histopathological confirmation of pCR. Recent data suggest that in selected women with exceptional clinical and imaging response, post-NACT, pre-surgery large volume, vacuum-assisted core biopsy (VACB) of the imaging residuum can reliably identify those who achieve pCR and therefore may not benefit from surgery. ASTARTE is a pilot study aiming to evaluate the safety of omission of surgery in a selected group of women with exceptional response to NACT. Methods : Fifty women with unifocal, T1-2, N0, M0, TN or HER2-positive invasive ductal carcinoma of the breast will be entered in the study. To be eligible, women must have completed standard NACT and achieved a complete or near complete imaging response on ultrasound scan +/- mammogram. They must have also demonstrated a pCR on post-NACT VACB following a standardized protocol. These women will not undergo breast and axillary surgery following completion of NACT but will receive radiotherapy and will continue systemic treatments as indicated. The primary endpoint of the study is the biopsy proven ipsilateral breast tumour recurrence free survival at 5 years. Results will provide data that might support a paradigm change in the treatment of breast cancer.
P124
Topic: Other
Background: Neoadjuvant chemotherapy (NACT) is increasingly used in phenotype-appropriate, early-stage breast cancer. Modern chemotherapy regimens and the use of targeted therapies can eliminate gross disease in increasing number of women. Particularly in triple negative (TN) and HER2-positive subtypes, pathologic complete response (pCR) rates exceeding 60% have been reported. In these cases, the role of surgery is limited to histopathological confirmation of pCR. Recent data suggest that in selected women with exceptional clinical and imaging response, post-NACT, pre-surgery large volume, vacuum-assisted core biopsy (VACB) of the imaging residuum can reliably identify those who achieve pCR and therefore may not benefit from surgery. ASTARTE is a pilot study aiming to evaluate the safety of omission of surgery in a selected group of women with exceptional response to NACT. Methods : Fifty women with unifocal, T1-2, N0, M0, TN or HER2-positive invasive ductal carcinoma of the breast will be entered in the study. To be eligible, women must have completed standard NACT and achieved a complete or near complete imaging response on ultrasound scan +/- mammogram. They must have also demonstrated a pCR on post-NACT VACB following a standardized protocol. These women will not undergo breast and axillary surgery following completion of NACT but will receive radiotherapy and will continue systemic treatments as indicated. The primary endpoint of the study is the biopsy proven ipsilateral breast tumour recurrence free survival at 5 years. Results will provide data that might support a paradigm change in the treatment of breast cancer.
Topic: Other
Background: Neoadjuvant chemotherapy (NACT) is increasingly used in phenotype-appropriate, early-stage breast cancer. Modern chemotherapy regimens and the use of targeted therapies can eliminate gross disease in increasing number of women. Particularly in triple negative (TN) and HER2-positive subtypes, pathologic complete response (pCR) rates exceeding 60% have been reported. In these cases, the role of surgery is limited to histopathological confirmation of pCR. Recent data suggest that in selected women with exceptional clinical and imaging response, post-NACT, pre-surgery large volume, vacuum-assisted core biopsy (VACB) of the imaging residuum can reliably identify those who achieve pCR and therefore may not benefit from surgery. ASTARTE is a pilot study aiming to evaluate the safety of omission of surgery in a selected group of women with exceptional response to NACT. Methods : Fifty women with unifocal, T1-2, N0, M0, TN or HER2-positive invasive ductal carcinoma of the breast will be entered in the study. To be eligible, women must have completed standard NACT and achieved a complete or near complete imaging response on ultrasound scan +/- mammogram. They must have also demonstrated a pCR on post-NACT VACB following a standardized protocol. These women will not undergo breast and axillary surgery following completion of NACT but will receive radiotherapy and will continue systemic treatments as indicated. The primary endpoint of the study is the biopsy proven ipsilateral breast tumour recurrence free survival at 5 years. Results will provide data that might support a paradigm change in the treatment of breast cancer.
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