Table 1 Eligibility criteria for the Triple-Negative Albumin-bound paclitaxel Combination International Treatment Study (tnAcity) trial
Key inclusion criteria | Key exclusion criteria |
|---|---|
Female, aged ≥ 18 years | Concurrent chemotherapy or any other antitumor breast cancer therapy |
Measurable metastatic disease | |
Pathologically confirmed as triple negative, defined as ER and PR expression both < 1 % of tumor cell nuclei per ASCO/CAP guidelinesa and HER2 negative per ASCO/CAP guidelinesa (IHC 0 or 1+ or FISH−, or IHC 2+ and FISH−) | Concurrent chemotherapy or any other antitumor therapy for breast cancer. Prior immunotherapy or monoclonal antibody therapy for metastatic breast cancer is acceptable |
If prior ER/PR/HER2+ breast cancer history, must have pathologically confirmed TN disease in ≥ 1 metastatic site | Receipt of prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease |
ECOG PS 0–1 | History or current evidence of brain metastasis, including leptomeningeal involvement |
No prior cytotoxic chemotherapy for metastatic disease; prior radiation therapy allowed | History of other primary malignancy in the past 5 years, except prior history of breast or in situ/basal/localized squamous cell skin cancer |
Must have received previous adjuvant or neoadjuvant anthracycline therapy unless not indicated by physician | Baseline peripheral neuropathy grade ≥ 2 by NCI CTCAE v4.0 |
Patients with newly diagnosed mTNBC are eligible if anthracycline not indicated by physician | Patients with bone as the only site of metastatic disease |
Completion of prior neoadjuvant or adjuvant chemotherapy ≥ 6 months before randomization or ≥ 12 months if containing taxane, gemcitabine, or platinum agents | Patients with regional lymph node as the only site of metastatic disease |