At a glance
ClinicalIndex Comparison Record- ✓Women or men 18 years or older
- ✓Histologically confirmed breast cancer with invasive component ≥20 mm and/or morphologically confirmed spread to regional lymph nodes (stage cT2-cT4 with any cN, or cN1-cN3 with any cT)
- ✓Known ER and/or PR status, with ≥10% cell nuclei staining for positivity
- ✓Known HER2-positive status (IHC 3+ or ISH positive if IHC 2+)
- ✕Distant metastases including contralateral thoracic, mediastinal node metastases
- ✕Other malignancy in past five years (except skin cancers or cervical carcinoma in situ)
- ✕History of invasive breast cancer
- ✕History of DCIS except if treated exclusively with mastectomy >5 years prior
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE
In Brief
A Phase 2 clinical trial evaluating Trastuzumab deruxtecan, Docetaxel, and 8 other interventions for Breast Cancer. Currently recruiting, targeting 370 participants across 7 sites.
Detailed Summary
The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.
Study Details
Timeline
Interventions
Experimental drug. Provided in 100mg vials. IV infusion.
Active comparator. IV infusion.
Active comparator. IV infusion.
Active comparator. IV infusion.
Active comparator. IV infusion.
Active comparator. IV infusion.
Experimental drug. Tablets.
Experimental drug. Tablets.
Active comparator. IV infusion.
Active comparator. IV infusion.