Recommendations:...If a patient’s cancer is hormone receptor positive and HER2 positive, clinicians may recommend either:...Endocrine therapy plus trastuzumab or lapatinib (in selected cases; Type: evidence based; Evidence quality: high; Strength of recommendation: moderate).

HER2 Positive Breast Cancer: Invasive Breast Cancer…SYSTEMIC THERAPY FOR ER - AND/OR PR - POSITIVE RECURRENT OR STAGE IV (M1) DISEASE…HER2-Positive and Postmenopausal Receiving Ovarian Ablation or Suppression…Aromatase inhibhitor+/-trastuzumab

The NCCN Panel has included other combinations of available endocrine therapies such as fulvestrant or tamoxifen with trastuzumab as options for HR-positive and HER2-positive metastatic disease.

Of the 28 patients, partial response was observed in 1 (4%), stable disease in 17 (61%), and progressive disease in 10 (36%) patients. The disease control rate was 64%....Trastuzumab and fulvestrant combination therapy showed moderate clinical efficacy and no severe toxicity after standard anti-HER2 treatment, which is a reasonable treatment option for patients with hormone receptor- and HER2-positive metastatic breast cancer.

We conducted an open-label, non-inferiority, phase-3, randomized, controlled trial (NCT01950182) at nine hospitals in China. Patients with HR+HER2+ MBC were enrolled....After a median follow-up of 30.2 months (IQR 15.0-44.7), the median PFS was 19.2 months (95%CI 16.7-21.7) in the ET group and 14.8 months (12.8-16.8) in the CT group (hazard ratio 0.88, 95%CI 0.71-1.09; pnon-inferiority <0.0001)....Trastuzumab plus endocrine therapy was non-inferior to trastuzumab plus chemotherapy in patients with HR+HER2+ MBC.

A total of 392 patients were enrolled and assigned randomly to receive trastuzumab plus endocrine therapy (ET group, n=196) or trastuzumab plus chemotherapy (CT group, n=196). After a median follow-up of 30.2 months (IQR 15.0-44.7), the median PFS was 19.2 months (95%CI 16.7-21.7) in the ET group and 14.8 months (12.8-16.8) in the CT group (hazard ratio 0.88, 95%CI 0.71-1.09; pnon-inferiority <0.0001)....Trastuzumab plus endocrine therapy was non-inferior to trastuzumab plus chemotherapy in patients with HR+HER2+ MBC.

Patients with hormone receptor-positive and HER2-positive histologically confirmed advanced breast cancer were randomly assigned (1:1) to receive trastuzumab plus chemotherapy (CT group) or endocrine therapy (ET group)....the median PFS was 14.8 months (95% CI 12.8-16.8) in the CT group and 19.2 months (95% CI 16.7-21.7) in the ET group (HR 0.88, 95% CI 0.71-1.09; Pnon-inferiority< 0.0001)....Trastuzumab plus endocrine therapy could provide more convenient treatment and allow better treatment tolerance.

We evaluated a cohort of patients treated with trastuzumab in the Czech Republic….The present study is a retrospective analysis of patients whose data were recorded in a nationwide non-interventional, post-authorisation database BREAST. After propensity score matching of data, the cohort included 4,532 patients....Increased OS rates were found in several subgroups of patients with HR+/HER2+ tumours compared to those with HR-/HER2+ tumours.

...- Hormone receptor-positive disease and planning to receive treatment with neoadjuvant aromatase inhibitor and ovarian suppression therapy (if premenopausal)...

...Pathological complete response in the breast and axilla (pCRBL) to dual HER2 blockade with lapatinib and trastuzumab, in all patients, at the time of surgery, predicted by PAM50 HER2-E subtype`Residual cancer burden in the breast (RCB) to dual HER2 blockade with lapatinib and trastuzumab, in all patients, at the time of surgery, predicted by PAM50 HER2-E subtype`Changes in the percentage of Ki67-positive cells in PAM50 non-Luminal A/B (combined) subtypes`Gene expression variations in all patients, in HR-negative and in HR-positive patients`Correlation between PAM50 HER2-E centroid, as a continuous variable, and pCR and/or RCB in the breast to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery`Identification of additional gene expression signatures beyond the PAM50 subtypes that predict pCR and/or RCB to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery`PAM50 risk of relapse (ROR) score and its ability to predict pCR and/or RCB in the breast to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery in all patients and in those with HR-positive and HR-negative disease`PAM50 HER-2 subtype (PAM50 HER2-E signature) ability as a continuous variable to predict pCRB to dual HER2 blockade at the time of surgery in patients with HR-positive disease and in patients with HR-negative disease`Changes in gene expression from day 0 to day 14, after dual HER2 blockade, that predict pCRB in all patients and in those with HR-positive and HR-negative disease`Frequency of adverse events (AE) when lapatinib plus trastuzumab, with or without endocrine therapy, is administered in the neoadjuvant setting...

...Hormone receptor positive (definition: immunohistochemistry estrogen receptor ≥ 1%, and/or progesterone receptor ≥ 1%), HER2 positive (definition: standard immunohistochemistry 3+or ISH positive); 6....

...while if a patient is HR positive(ER and/or PR ≥10%）,the longest diameter of invasive cancer is greater than 1cm and...

...Ratio (95% CI) of Geometric Means in p95HER2 Expression in HR Positive Patients With pCR vs no pCR`Percentage of Participants With Circulating Tumor Cells (CTC) in the Bloodstream...

...while if a patient is HR positive(ER and/or PR ≥10%）,the longest diameter of invasive cancer is greater than 1cm and...

692 consecutive patients with pT1N0 HER2-positive IDC of the breast were included….ER+PR+ (HR = 0.44, 95%CI 0.26-0.77, P = 0.004) and adjuvant trastuzumab (HR = 0.21, 95%CI 0.12-0.35, P< 0.001) were associated with favorable IDFS….For patients with T1N0 HER2-positive IDC of breast, age≤40, T1c, ER+PR+, adjuvant trastuzumab are independent prognostic factors. We recommend adjuvant chemotherapy plus trastuzumab, especially for patients with T1c tumors.

For triple-positive breast cancer, maintenance endocrine therapy was aslo given concurrently with trastusumab in 75 patients after chemotherapy and trastusumab….Multivariate analysis revealed that HR positive [hazard ratio, 0.69; 95% confidence interval (CI), 0.52–0.92; P= 0.010], and non-brain metastasis (hazard ratio, 0.54; 95% CI, 0.29–0.99; P= 0.048) were independent prognostic factors. Further Kaplan–Meier analysis demonstrated triple-positive patients with maintenance endocrine therapy significantly had longer PFS than triple-positive patients without maintenance endocrine therapy and HER2+/HR- patients (21.33m vs. 10.13m vs. 9.53m, respectively, P< 0.001)....HR-positive was an independent prognostic factor for HER2-positive advanced breast cancer patients receiving first-line chemotherapy with trastuzumab.

...multicentric study which aimed to describe the clinical outcome of patients with HR + /HER2 + ABC who received the combination of Fulvestrant (F) and Trastuzumab (T)...Among the 86 evaluable patients, 6 (6.9%) achieved CR, 18 (20.7%) PR, and 44 (50.6%) had SD ≥ 24 weeks with an overall CBR of 78.2%. At a median follow-up of 33.6 months, mPFS of the entire cohort was 12.9 months (range, 2.47-128.67).

Sixteen patients had HER2 positive, hormone receptor (HR) positive tumors and 6 patients a HER2 positive, HR negative tumors….patients treated with neoadjuvant therapy with trastuzumab (proposed biosimilar or trastuzumab)...Breast pCR was achieved in 86% (n=6) and 33% (n=5) in trastuzumab and proposed biosimilar groups respectively.

...375 patients (pts) with HR+/HER2+ BC were randomized to 12 weeks of T-DM1 +/- standard ET and trastuzumab+ET q3w (ratio 1:1:1)....pCR (vs. non-pCR) after the 12-week study treatment was strongly associated with improved DFS (5y DFS 92.7% vs. 82.7, HR=0.40, 95% CI 0.18-0.85)….Early pCR after 12 weeks of therapy was strongly associated with improved outcome in ADAPT TP and may serve as a predictive marker for CT treatment (de)-escalation.

We found that the addition of trastuzumab to NAC improved relative survival benefit in HER2+/HR+ patients than in HER2+/HR- patients, even though the pCR rate increases were lower.

A 50-year-old premenopausal woman...the patient was diagnosed with liver, lung, and left cervical lymph node metastatic HER2-positive and HR-positive carcinoma from the left breast after systemic therapy….She was treated with trastuzumab, leuprorelin, letrozole, and piperacillin combined with percutaneous transhepatic cholangic drainage....The patient's symptoms were relieved, her liver function returned to normal, and the tumor showed partial response....To date, the progression-free survival of the patient is over 14 months.