Table 2.
Trial identifier | Status | Setting | Target group | Arms/treatment | POM |
---|---|---|---|---|---|
KEYNOTE-522 |
A N/R |
Neoadjuvant, adjuvant |
Locally advanced TNBC |
1. PXL + CBDCA + placebo → AC/EC + placebo → surgery → placebo 2. PXL + CBDCA + pembrolizumab → AC/EC + pembrolizumab → surgery → pembrolizumab (Q3W) |
pCR rate (ypT0/Tis ypN0) |
Treatment-naïve locally advanced non-metastatic (M0) TNBC: T1c, N1-N2 T2, N0-N2 T3, N0-N2 T4a-d, N0-N2 | |||||
EFS | |||||
NCT02954874 | R | Adjuvant | TNBC or ER-, PgR- weakly positive and/or HER2-equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or ETs after completion of neoadjuvant chemotherapy |
1. Observation (± Rth) 2. Pembrolizumab (every 42 days for 52 weeks) ± Rth |
IDFS |
HER2- and HER2-equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy | |||||
Weakly ER or PgR positive disease (ER and/or PgR ≤ 5% by IHC) are eligible if the patient is not eligible for adjuvant ET | Severity of fatigue | ||||
Residual disease must be ≥ 1 cm in greatest dimension, and/or ypN1mi, ypN1, ypN2, ypN3 | Physical function | ||||
KEYNOTE-355 |
A N/R |
Recurrence, Metastatic |
Treatment-naïve: locally recurrent inoperable breast cancer which cannot be treated with curative intent |
Part 1: 1. Pembrolizumab (200 mg/Q3W) + nab-PXL 2. Pembrolizumab (200 mg/Q3W) + PXL 3. Pembrolizumab (200 mg/Q3W) + GEM/CBDCA Part 2: 1. Pembrolizumab (200 mg/Q3W) + chemotherapy 2. Placebo + chemotherapy |
Part 1: percentage of participants who experience an AE—all |
Percentage of participants who discontinue study drug due to an AE—all | |||||
Part 2: PFS and OS—all | |||||
MBC | PFS and OS in those with PD-L1–positive CPS ≥ 1 tumours, and with CPS ≥ 10 tumours | ||||
KEYLYNK-009 |
R |
Recurrence, metastatic |
Treatment-naïve: locally recurrent inoperable TNBC that cannot be treated with curative intent |
1. CBDCA + GEM + pembrolizumab → CBDCA + GEM + pembrolizumab (200 mg/Q3W) 2. CBDCA + GEM + pembrolizumab → pembrolizumab (200 mg/Q3W) + olaparib |
PFS |
MBC | OS | ||||
NeoTRIPaPDL1 |
A N/R |
Neoadjuvant adjuvant |
Early high-risk and locally advanced or inflammatory breast cancers |
1. CBDCA + nab-PXL + atezolizumab → surgery → AC or EC or FEC 2. CBDCA + nab-PXL → surgery → AC or EC or FEC |
EFS |
IMpassion030 |
R |
Neoadjuvant adjuvant |
Operable stage II-III |
1. Atezolizumab (840 mg/Q2W) + PXL → atezolizumab + ddAC/ddEC → surgery → atezolizumab (1200 mg/Q3W to complete 1 year of treatment from the first dose) 2. PXL → ddAC/ddEC → surgery |
IDFS |
IMpassion031 |
A N/R |
Neoadjuvant adjuvant |
cT2-cT4, cN0-cN3, cM0 |
1. Atezolizumab (840 mg/Q2W) + nab-PXL → atezolizumab (840 mg/Q2W) + AC → surgery → atezolizumab (1200 mg/Q3W, 11 doses) 2. Placebo + nab-PXL → placebo + AC → surgery |
Percentage of participants with pCR |
Percentage of participants with pCR in subpopulation with PD-L1–positive tumour status | |||||
NCT03281954 | R | Neoadjuvant, adjuvant | T2 or T3, N0 |
1. PXL + CBDCA + placebo → AC/EC + placebo → surgery → placebo 2. PXL + CBDCA + atezolizumab → AC/EC + atezolizumab → surgery → atezolizumab (1200 mg/Q3W) |
pCR in the breast and lymph nodes (ypT0/Tis ypN0) |
cN1 (cytologically or histologically positive) or cN2-N3 (with or without a biopsy), then can be clinically T1c, T2, or T3 | EFS | ||||
IMpassion131 |
A N/R |
Locally advanced, metastatic |
Treatment-naïve: locally advanced |
1. Atezolizumab (840 mg/Q2W) + PXL 2. Placebo + PXL |
PFS in the subpopulation with PD-L1(+) tumour status |
MBC not amenable to surgical therapy | PFS in the intent-to-treat population | ||||
IMpassion132 |
R |
Recurrence, locally advanced, metastatic |
Treatment-naïve: locally recurrent, inoperable |
1. Atezolizumab (1200 mg/Q3W) + chemotherapy (GEM + CBDCA or capecitabine) 2. Placebo + chemotherapy (GEM + CBDCA or capecitabine) |
OS in population with PD-L1(+) tumour status |
Locally advanced | OS in modified intent-to-treat popluation | ||||
MBC | |||||
NCT04177108 | R |
Locally advanced unresectable, metastatic |
Treatment-naïve: locally advanced unresectable |
PD-L1(-): 1. PXL + atezolizumab + ipatasertib 2. PXL + placebo + ipatasertib 3. PXL + placebo + placebo PD-L1(+): 1. PXL + atezolizumab + ipatasertib 2. PXL + atezolizumab + placebo |
PFS |
MBC | OS |
TNBC triple-negative breast cancer, POM primary outcome measures, A N/R Active not recruiting, PXL paclitaxel, CBDCA carboplatin, AC/EC doxorubicin plus cyclophosphamide/epirubicin plus cyclophosphamide, Q3W every 3 weeks, pCR pathological complete reponse, EFS event-free survival, R recruiting, ER estrogen receptor, PgR progesterone receptor, HER2 human epidermal growth factor receptor 2, ET endocrine therapy, ASCO CAP American Society of Clinical Oncology College of American Pathologists, IHC immunohistochemistry, Rth radiotherapy, IDFS invasive disease-free survival, MBC metastatic breast cancer, GEM gemcitabine, AE adverse event, PFS progression-free survival, OS overall survival, PD-L1 programmed cell death ligand 1, CPS combined positive score, FEC fluorouracil, epirubicin and cyclophosphamide, Q2W every 2 weeks, dd dose-dense