Invasive Breast Cancer: HER-2 negative...Other Recommended Regimens…Albumin-bound paclitaxel…

...- HER2/neu-negative....

...- Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;...

...Patients with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. ...

...• Histologically or cytologically confirmed HER-2 negative, newly diagnosed breast cancer • Metastatic breast cancer with measurable disease (by RECIST criteria) • Age >18 • PS: 0-2 • No prior chemotherapy for metastatic disease • ≥12 months since adjuvant paclitaxel and/or anthracyclines therapy • Patients not candidates for endocrine therapy • No peripheral neuropathy grade > 1 • No brain metastases or clinically serious concurrent illnesses • Previous anthracycline (adjuvant setting) maximum dose of doxorubicin 360 mg/mq and epirubicin 480 mg/mq • Adequate organ function (obtained within 14 days prior to treatment study) as evidenced by: o Absolute neutrophil count (ANC) 1.5 X 109/L without myeloid growth factor support for 7 days preceding the lab assessment; o Haemoglobin (Hgb) 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if hemoglobin is corrected to 9 g/dL (90 g/L) as assessed by the central laboratory by growth factor or transfusion prior to randomization; o Platelet count 75 X 109/L without blood transfusions for 7 days preceding the lab assessment; o Bilirubin 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert’’s disease; Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 2.5 X ULN (for patients with liver metastases 5 X ULN); o Alkaline phosphatase 3 X ULN (for patients with liver metastases, 5 X ULN); o Serum creatinine 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance 50 mL/min (using Cockcroft-Gault formula); o Women of childbearing potential (WCBP): negative serum pregnancy test (this test is required of all women unless post-menopausal, defined as 12 consecutive months since last regular menses, or surgically sterile). ...

...histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (...

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...- Tumor must be HER-2-neu negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio less than or equal to 2.0, by fluorescent in situ hybridization...

...- HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer....

...- Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer....

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...Her-2 negative is defined as immunohistochemistry for Her-2 (-) or (1+), where a FISH test must be negative for Her-2 (2+) and a negative result for Her-2 (-) or (1+);...

...HER2 negative is defined as: When immunohistochemistry detects HER-2 0 or 1+, or++, FISH detection is negative without amplification;...

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...- HER2-negative disease...

...- Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer....

...more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory)....

...- Histologically documented Her-2 negative -...

...HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative); 4....

...Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence [such as high Ki67 expression (≥20%), T > 2 cm, age 2 cm; 7....

...- Luminal B-like tumors (ER and/or PgR positive, HER2 negative, Ki-67 > 20%) with involved lymph nodes or...

...Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology...

Patients with HER2-negative mBC were enrolled and randomly assigned (1:1) to receive nab-paclitaxel for a 3-week schedule...Patients in the 2 arms had a similar overall survival (28.0 vs. 25.8 months), objective response rate (51.1% vs. 48.9%), and disease control rate (93.6% vs. 80.9%)...This study demonstrated the better antitumor activity and safety profile of a 3-week over 4-week nab-paclitaxel schedule in HER2-negative mBC...

This is a single-center, open-label, randomized, phase II trial. Eligible female patients with HER-2 negative recurrent/metastatic breast cancer....In two groups, respectively, median PFS was 9.6 months and 7.5 months (HR 0.905; 95%CI 0.569-1.440) and ORR were 50.0% (23/46) and 46.9% (23/49) in the evaluable population. Median OS was 22.5 months in the 3-week group and has not yet been reached for the 4-week group....Preliminary results suggest that compared with the 4-week regimen, the 3-week regimen of nab-paclitaxel seems to be more suitable and adaptable for Chinese patients with advanced breast cancer.

The pathological complete response (pCR)(ypT0/isN0) rate was significantly higher in the nab-paclitaxel group than in the docetaxel group (36.71% vs 20.00%; P = 0.031)....Compared with docetaxel, nab-paclitaxel achieved a higher pCR rate, especially those patients with triple-negative breast cancer or lymph node negative breast cancer.

In this retrospective analysis, a total of 159 HER2-negative breast cancer patients underwent operation after NAC...The pathological complete response (pCR)(ypT0/isN0) rate was signifcantly higher in nab-paclitaxel group than in docetaxel group (36.71% vs 20.00%; P=0.031).

This was an open-label, single-arm, phase II, single-institution prospective study of 4 cycles of nab-paclitaxel (260 mg/m2) administered intravenously on day 1 in combination with S-1 (65 mg/m2 orally twice daily) on days 1 to 14 every 21 days followed by EC as neoadjuvant chemotherapy. pCR was observed in 57.1% of luminal B human epidermal growth factor receptor type 2 (HER2)-negative patients, 55.6% of luminal B HER2-positive patients, 100% of HER2-positive patients, and 57.1% of triple-negative breast cancer patients.

The current study was to investigate the safety and efficacy of low-dose nab-PTX for HER2-negative MBC in Japanese patients….No patient achieved CR, seven patients (41%) showed PR, and 7 patients showed SD (one patient longer than 24 weeks and six patients shorter than 24 weeks)...The ORR was 41% (95%CI=17.8-64.5), CBR was 47% (95%CI=23.3-70.8)...

We conducted a retrospective study to compare the efficacy and safety of Nab-PTX to PTX as neoadjuvant chemotherapy for patients with operable HER2-negative breast cancer….The cCR rate for the Nab-PTX regimen was 48% (12/25), which was higher than the rate of 16% (4/25) for the PTX regimen; this difference was statistically significant (P = 0.032).