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Triage: High /protocolSection/eligibilityModule/eligibilityCriteria Matched rules
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eligibility_criteria_changeEligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ol><li>Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.</li><li>A participant is eligible to participate if she is not pregnant, not breastfeeding.</li><li>The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.</li><li><p>Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:</p><ul><li>HER2-positive status by local determination according to 2018 ASCO/CAP guidelines.</li><li>PAM50 HER2-enriched subtype and ERBB2-high as predefined cutoff as per central determination.</li><li>Unifocal invasive carcinoma: only 1 invasive focus can be observed (the tumor focus containing or not containing an in situ component)</li><li>Tumor largest diameter ≤2 cm as defined by breast MRI.</li><li>No nodal involvement (i.e. cN0). Any suspicious axillary node by ultrasound must be biopsied. If the biopsy or the FNA is negative of tumor cells, patient is eligible.</li><li>No evidence of distant metastasis (M0) by routine clinical assessment.</li></ul></li><li>Patient must have known ER and PR status locally determined prior to study entry.</li><li>Eligible for taxane therapy.</li><li>Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy.</li><li>Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.</li><li>Breast cancer eligible for primary surgery</li><li>Have provided archival tumor tissue sample or newly obtained core. Formalin-fixed,paraffin embedded (FFPE) tissue blocks are mandatory. Available pre-treatment FFPE core biopsy evaluable for PAM50 or possibility to obtain one.</li><li>Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.</li><li>Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.</li><li>Have adequate organ function.</li></ol><p>Exclusion Criteria:</p><ol><li>Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.</li><li>Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.</li><li>Clinical stage II, III or IV.</li><li>History of radiotherapy in the ipsilateral breast or axilla.</li><li>History of surgery of the ipsilateral axilla.</li><li>Bilateral invasive breast cancer.</li><li>Infiltrating lobular carcinoma.</li><li>Multicentric or multifocal breast cancer, defined as the presence of two or more foci of cancer in the same or different quadrants of the same breast.</li><li>Patients who have undergone sentinel lymph node biopsy prior to study treatment.</li><li>Patient has active cardiac disease or a history of cardiac dysfunction</li><li>Has an active infection requiring systemic therapy.</li></ol><p>13. Patients with a history of previous breast cancer are excluded.</p>
After
<p>Inclusion Criteria:</p><ol><li>Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.</li><li>A participant is eligible to participate if she is not pregnant, not breastfeeding.</li><li>The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.</li><li><p>Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:</p><ul><li>HER2-positive status by local determination according to 2018 ASCO/CAP guidelines.</li><li>PAM50 HER2-enriched subtype and ERBB2-high as predefined cutoff as per central determination.</li><li>Unifocal invasive carcinoma: only 1 invasive focus can be observed (the tumor focus containing or not containing an in situ component)</li><li>Tumor largest diameter ≤4 cm as defined by breast MRI.</li><li>No nodal involvement (i.e. cN0). Any suspicious axillary node by ultrasound must be biopsied. If the biopsy or the FNA is negative of tumor cells, patient is eligible.</li><li>No evidence of distant metastasis (M0) by routine clinical assessment.</li></ul></li><li>Patient must have known ER and PR status locally determined prior to study entry.</li><li>Eligible for taxane therapy.</li><li>Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy.</li><li>Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.</li><li>Breast cancer eligible for primary surgery</li><li>Have provided archival tumor tissue sample or newly obtained core. Formalin-fixed,paraffin embedded (FFPE) tissue blocks are mandatory. Available pre-treatment FFPE core biopsy evaluable for PAM50 or possibility to obtain one.</li><li>Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.</li><li>Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.</li><li>Have adequate organ function.</li></ol><p>Exclusion Criteria:</p><ol><li>Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.</li><li>Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.</li><li>Clinical stage II, III or IV.</li><li>History of radiotherapy in the ipsilateral breast or axilla.</li><li>History of surgery of the ipsilateral axilla.</li><li>Bilateral invasive breast cancer.</li><li>Infiltrating lobular carcinoma.</li><li>Multicentric or multifocal breast cancer, defined as the presence of two or more foci of cancer in the same or different quadrants of the same breast.</li><li>Patients who have undergone sentinel lymph node biopsy prior to study treatment.</li><li>Patient has active cardiac disease or a history of cardiac dysfunction</li><li>Has an active infection requiring systemic therapy.</li></ol><p>13. Patients with a history of previous breast cancer are excluded.</p>