Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction an… (NCT04578106) | Clinical Trial Compass
TerminatedPhase 2
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
Stopped: The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible
Spain5 participantsStarted 2020-09-23
Plain-language summary
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab. The primary trial objective is to estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging (i.e. Magnetic resonance imaging) and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.
Who can participate
Age range40 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. A participant is eligible to participate if she is not pregnant, not breastfeeding.
✓. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
✓. Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:
✓. Patient must have known ER and PR status locally determined prior to study entry.
✓. Eligible for taxane therapy.
✓. Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy.
✓. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
Exclusion criteria
✕. Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.
✕. Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.
✕. Clinical stage II, III or IV.
✕. History of radiotherapy in the ipsilateral breast or axilla.
✕. History of surgery of the ipsilateral axilla.
✕. Bilateral invasive breast cancer.
✕. Infiltrating lobular carcinoma.
✕. 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.