...Patients with locally advanced or metastatic breast cancer diagnosed as HER2-negative by molecular typing; 5. ...

...- All patients were HER2 negative, defi ned as munohistochemistry of 0/1+, or if 2+, fl uorescence insitu hybridisation showed...

......

...- Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;...

...Histologically confirmed Triple-Negative invasive breast carcinoma：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-) 4....

...The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as >1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection...

...- Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization); -...

...HR-positive and HER2-negative breast cancer diagnosed by histology; 5. ...

...1) aged > 18 years old, < 70 years old; 2) pathologically confirmed HER2 negative primary breast cancer (HER2 negative is defined as immunohistochemical 0 or 1+ or fluorescence in situ hybridization without amplification); 3) metastatic breast cancer was diagnosed by pathology and imaging; 4) there is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1; 5) anthracyclines or taxanes have been used in adjuvant, neoadjuvant or advanced treatment; 6) received at least 1 line of chemotherapy in the advanced stage of treatment; Hormone receptor positive patients received at least 1 line of endocrine therapy; 7) the Eastern Cooperative Oncology Group (ECOG) scored 0-2; 8) any previous treatment should be completed at least 4 weeks prior to enrollment; 9) hematuria routine and examination of heart, liver, kidney and coagulation function were basically normal; Child-pugh liver function rating: grade A or better grade B (>= 7); (1) The standard of blood routine examination should be: HB >= 90g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10^9 / L; PLT 60 x 10^9 / L or higher; (2) biochemical examination should meet the following standards: ALB >= 29g/L; TBIL < 1.5 ULN. ...

...Her-2 negative is defined as: immunohistochemical detection of Her-2 (-) or (1 +), in which Her-2 (2+) must be tested by FISH and the result is negative, such as Her-2 (-) or ( 1+) can choose to perform FISH detection, but the result must be negative; 5. ...

...Patients with locally advanced or metastatic breast cancer diagnosed as HER2-negative by molecular typing;...

This open-label, single-arm, phase II study enrolled women ≥ 18 years with HER2-negative breast cancer who underwent ≥1 line chemotherapy, All patients were treated with intravenous irinotecan (60mg/m2 on days 1 and 8) and oral anlotinib (12 mg once daily on days 1-14)....4(26.7%) and 9(60%) patients got partial response (PR) and stable disease (SD), respectively. ORR was 26.7% (95% CI 7.8-55.1) and DCR was 86.7% (95% CI 59.5-98.3).

The median PFS was 3.5 months [95% confidence interval (CI) 2.8-5.5 months] for eribulin and 5.1 months (95% CI 4.5-6.9 months) for eribulin plus anlotinib (hazard ratio = 0.56, 95% CI 0.32-0.98; P = 0.04). The objective response rates were 32.5% versus 52.5% (P = 0.07), respectively, and disease control rates were 67.5% versus 92.5% (P = 0.01), respectively....Eribulin plus anlotinib can be considered an alternative treatment option for HER2-negative locally advanced or metastatic breast cancer.

From November 2020 to November 2022, 14 patients were enrolled in this study. Median follow-up was 10.8 months (95% CI 4.3-17.3). Median PFS was 5.9 months (95% CI 2.0-9.8). Of all the patients whose efficacy could be evaluated (13/14)...8(61.54%) patients got partial response (PR) and stable disease (SD), respectively. ORR was 23.1% (95% CI 5.0-53.8) and DCR was 84.6% (95% CI 54.6-98.1)...The combination of irinotecan and anlotinib showed better treatment response and tolerable toxicity in the treatment of second-line and above patients with HER2-negative metastatic breast cancer.

Median PFS was 4.7 months (95% CI 3.59-5.53). Of all the patients whose efficacy could be evaluated, no patient achieved complete response (CR); 17 (44.74%) and 15 (39.47%) patients got partial response (PR) and stable disease (SD), respectively. ORR was 44.74% and DCR was 86.84%....The combination of eribulin and anlotinib improved the survival of HER2-negative metastatic breast cancer patients and showed tolerable toxicities.

Anlotinib monotherapy or combination therapy provide a viable third-line or above therapeutic strategy in patients with HER-2 negative metastatic breast cancer, a median PFS of 5.0 months was obtained with well tolerated toxicity.

Median PFS was 4.6 months (95% CI 3.55-5.65). Of all the patients whose efficacy could be evaluated (21/25), no patient achieved complete response (CR); 9 (40.91%) and 10 (45.45%) patients got partial response (PR) and stable disease (SD), respectively. ORR was 40.91% and DCR was 86.36%....The combination of eribulin and anlotinib showed a better treatment response and tolerable toxicity in HER2-negative metastatic breast cancer patients.

Anlotinib showed objective efficacy with tolerable toxicity in heavily pre-treated, metastatic HER2-negative breast cancer.