Table 4.
Levels of evidence and grades of recommendation of the consensus meeting statements.
| Statements | Percentage of Consensus Votes | Level of Evidence (LOE) | Grade of Recommendation (GOR) |
|---|---|---|---|
| TNBC disease is defined as HER2− with ER and PR expression <1%. | 85.5% | I | A |
| HER2− and ER/PR expression between 1–10% tumours would be treated clinically as TNBC, being not eligible to receive endocrine therapy as a monotherapy. | 61.5% | IV | C |
| Germline BRCA mutation testing for TNBC patients is indicated if diagnosed at ≤60 years or with strong family history in order to plan for genetic counselling and risk reduction measures for the patient and her family. | 67% | II | B |
| Androgen receptor (AR) reporting has no current role in TNBC management plan and should be reported in TNBC cases for research purposes only. | 77% | II | B |
| TILs reporting has no current role in standard of care of TNBC and should be reported for research purposes only. If reported, it should be according to the International Working Group Criteria, 2014, on the stromal +/− intra-tumoural immune cells. | 44% | II | A |
| Ki67 has no evident role in the current standard of care of TNBC and should be reported for research purposes only. | 70% | II | A |
| It is mandatory to repeat hormonal receptors and HER2 assessment after neo-adjuvant treatment in TNBC patients with any residual disease. Capturing any overexpression of these markers avoids missing any opportunity of adjuvant therapy. | 75% | III | A |
| If HER2 assessment by IHC changed to HER2+ after neo-adjuvant treatment in TNBC, it is preferred to offer adjuvant anti-HER2 therapy. | 92.6% | Expert opinion | A |
| For early TNBC cases (cT1–2N0), mastectomy is not the preferred surgery for the ipsilateral breast, if the patient is eligible for BCT. | 100% | IV | A |
| For gBRCA1/2 mutant early TNBC, the surgical option for the ipsilateral breast is controversial, if the patient is eligible for BCT. | 100% | IV | C |
| For gBRCA1/2 mutant early TNBC patients, risk reduction contralateral mastectomy is advised. Taking into account, the patients’ age, stage, preference and risk of developing contralateral BC, rather than doctor’s recommendation solely. | 69% | IV | C |
| TNBC biology per se is not an absolute indication for postoperative radiation therapy after mastectomy for all pT1–2 N0 TNBC cases. | 91.6% | IV | C |
| Hypo-fractionation regimens can be considered for both early and advanced TNBC cases. | 87% | II | B |
| It is preferred to offer radiation therapy boost to tumour bed for all cases of TNBC after lumpectomy. | 58% | IV | B |
| After upfront surgery for pT1–3 N0 TNBC, offering regional nodal irradiation is based on the clinico-pathological features including but not limited to TNBC biology only, such as LVI and high grade. | 86% | II | B |
| After mastectomy for pN1 (1–3 + LNs) TNBC, regional nodal irradiation is preferred. | 76% | I | B |
| The preferred local management for the axilla for TNBC patients with Z-0011 criteria is controversial. | 100% | II | B |
| There is no preference regarding the timing of reconstruction (immediate vs. delayed) after breast surgery for TNBC. | 68% | II | B |
| For early-stage TNBC (cT2–3 N0); NAT is preferred over upfront surgery (regardless of the planned surgery type). | 93% | II | A |
| For early-stage TNBC (cT2–3 N1); NAT is preferred over upfront surgery (regardless of the planned surgery type). | 100% | I | A |
| NAT regimens for TNBC are preferred to be administered for 6–8 cycles. | 76% | I | B |
| Adding platinum to the standard anthracyclines/taxanes NAT regimen is preferred especially with stage II–III TNBC and if suboptimal tumour response was achieved following anthracyclines. | 77.6% | II | B |
| De-escalating the neo-adjuvant chemotherapy in TNBC by offering a short, anthracycline-free, taxane/platinum regimen only, for early responders (response adapted approach, ADAPT-TN trial), is not preferred. | 86% | II | B |
| A carboplatin-including regimen is preferred in the NAT setting for gBRCA1/2 mutant TNBC. | 69.2% | II | C |
| A carboplatin-including regimen is not preferred in the NAT setting for wBRCA1/2 TNBC | 66.6% | II | C |
| No mature data yet to support the use of Pembrolizumab or Atezolizumab in the NAT setting for early TNBC. | 72% | II | B |
| Capecitabine (6–8 cycles) is the preferred adjuvant therapy in case of absence of pCR after NAT (anthracyclines/taxanes) for TNBC. | 85% | II | A |
| In the presence of pCR after NAT (anthracylines/taxanes) for TNBC, no further adjuvant systemic therapy is advised. | 93% | II | A |
| Adjuvant chemotherapy for pT1a N0 TNBC can be omitted safely. | 88% | II | A |
| Adjuvant chemotherapy for pT1b N0 TNBC is preferred. | 97% | II | A |
| After upfront surgery, for stage I TNBC, the preferred adjuvant regimen is 6 cycles anthracyclines/taxanes. | 80% | I | A |
| After upfront surgery, for stage II–III TNBC, the preferred adjuvant regimen is 6–8 cycles anthracyclines/taxanes. | 61% | I | B |
| Dose dense AC-T regimen is a preferred one over standard regimen (/3 wks) in the adjuvant setting for stage II–III TNBC. | 88% | II | A |
| If TNBC case developed metastasis, tissue biopsy and testing for ER, PR, HER2, PDL-1/germline BRCA mutations are recommended. | 95% | I | A |
| After complete resection of isolated loco-regional recurrence (LRR) in non-metastatic TNBC, chemotherapy is recommended for 3–6 months. | 85% | II | A |
| Metastatic TNBC disease (mTNBC) is a heterogeneous disease and should be categorized as the following: (1) PD-L1+ mTNBC, (2) gBRCA mutant mTNBC, (3) PD-L1−/wBRCA mTNBC or no testing done. | 89% | I | A |
| Atezolizumab + nab-paclitaxel or Pembrolizumab + chemotherapy are preferred options over standard chemotherapy in the first-line setting for unresectable locally advanced/mTNBC expressing PD-L1 (PDL-1 ≥ 1% for Atezolizumab or CPS ≥ 10 for Pembrolizumab). | 86% | I | B |
| For the 1st-line immunotherapy for PDL1+ mTNBC, no preference for one over the other (Atezolizumab/Pembrolizumab) as no head-to-head comparison. | 58% | I | B |
| No mature data yet to support the use of Pembrolizumab in the subsequent lines in the metastatic setting of TNBC. | 93% | II | B |
| Atezolizumab plus nab-paclitaxel should be offered for unresectable locally advanced/mTNBC patients after PD-L1 testing to identify the PD-L1+ population. | 93% | I | A |
| If Atezolizumab is planned, PD-L1 should be tested using the Ventana SP142 IHC on the tumoural immune cells, with the cut-off value for PD-L1 positivity is 1%. | 94% | I | A |
| If Pembrolizumab is planned, PD-L1 should be tested by 22C3 pharmDx test, with the cut-off of CPS ≥ 10. | 93% | I | A |
| For gBRCA1/2 mutant mTNBC, a platinum or PARP inhibitor should be incorporated early in the treatment course. | 66% | I | A |
| No mature data yet to support the use of Veliparib in the metastatic setting of TNBC. | 86% | II | C |
| For mTNBC with PD-L1−/wBRCA or no testing done, the most efficacious sequencing of chemotherapy agents has yet to be defined. | 75% | II | B |
| For mTNBC with PD-L1−/wBRCA or no testing done, paclitaxel or nab-paclitaxel/carboplatin are preferred as a combination regimen. | 60% | III | C |
| For mTNBC with PD-L1−/wBRCA or no testing done, no preferred chemotherapy regimen in subsequent lines and enrolment in clinical trials is encouraged. | 75% | III | B |
| For mTNBC with PD-L1−/wBRCA or no testing done, eribulin is a preferred subsequent line of therapy after prior anthracyclines and taxanes. | 75% | II | B |
| In AR+ mTNBC, AR-directed therapy is not recommended for the management of mTNBC outside clinical trials. | 79% | II | D |
| Sacituzumab govitecan is preferred over chemotherapy after ≥ 2 prior chemotherapies for mTNBC. | 86% | I | A |