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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Focus V (anlotinib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A prospective study on efficacy and safety of anlotinib combined with fulvestrant in patients with HR-positive and HER2-negative, secondary endocrine-resistant, locally advanced or metastatic breast cancer
Excerpt:
...HR-positive and HER2-negative breast cancer diagnosed by histology; 5. ...
Trial ID:
Source:
Title:
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer
Excerpt:
......
Trial ID:
More C2 evidence
Source:
Title:
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
Excerpt:
...- Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;...
Trial ID:
Source:
Title:
ADCb (Anlotinib/Docetaxel/Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer
Excerpt:
...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....
Trial ID:
Source:
Title:
Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation
Excerpt:
...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...
Trial ID:
Source:
Title:
Anlotinib in Metastatic HER2 Negative Breast Cancer
Excerpt:
...- Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization); -...
Trial ID:
Source:
Title:
Clinical study on the treatment of second-line and above HER2 negative advanced breast cancer with anrotinib combined with capecitabine
Excerpt:
......
Trial ID:
Source:
Title:
A Controlled, Phase II Study of Anlotinib vs Placebo Combination with Vinorelbine for the Treatment of HER2- Advanced Breast Cancer
Excerpt:
...Patients with locally advanced or metastatic breast cancer diagnosed as HER2-negative by molecular typing; 5. ...
Trial ID:
Source:
Title:
A Single-arm, Single-Center Prospective Clinical Study of the Efficacy and Safety of Anlotinib and Etoposide in Subjects of Treating Triple-Negative Breast Cancer
Excerpt:
...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. ...
Trial ID:
Source:
Title:
Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer
Excerpt:
...Patients with locally advanced or metastatic breast cancer diagnosed as HER2-negative by molecular typing;...
Trial ID:
Source:
Title:
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Excerpt:
...- All patients were HER2 negative, defi ned as munohistochemistry of 0/1+, or if 2+, fl uorescence insitu hybridisation showed...
Trial ID:
Less C2 evidence
Source:
Title:
450P - A prospective, single-arm, single-center, exploratory clinical study of anlotinib combined with irinotecan in second-line and above treatment of HER-2-negative advanced breast cancer
Published date:
10/16/2023
Excerpt:
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).
Secondary therapy:
irinotecan
Source:
Title:
A randomized trial of eribulin monotherapy versus eribulin plus anlotinib in patients with locally recurrent or metastatic breast cancer
Published date:
06/05/2023
Excerpt:
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.
Secondary therapy:
eribulin mesylate
DOI:
10.1016/j.esmoop.2023.101563
Trial ID:
Source:
Title:
A prospective, single-arm, single-center, exploratory clinical study of anlotinib combined with irinotecan in second-line and above treatment of HER-2–negative advanced breast cancer.
Published date:
05/25/2023
Excerpt:
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.
Secondary therapy:
irinotecan
DOI:
10.1200/JCO.2023.41.16_suppl.e13114
Source:
Title:
244P - Eribulin combined with anlotinib for patients with HER2-negative metastatic breast cancer: A single-arm, multicenter, phase II study
Published date:
09/05/2022
Excerpt:
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.
Secondary therapy:
E7386
Trial ID:
Source:
Title:
A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer
Published date:
07/28/2022
Excerpt:
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.
DOI:
10.3389/fonc.2022.939343
Source:
Title:
Eribulin combined with anlotinib for patients with HER2-negative metastatic breast cancer: A single-arm, multicenter, phase II study.
Published date:
05/26/2022
Excerpt:
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.
Secondary therapy:
eribulin mesylate
DOI:
10.1200/JCO.2022.40.16_suppl.e13051
Trial ID:
Source:
Title:
Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer
Published date:
03/11/2021
Excerpt:
Anlotinib showed objective efficacy with tolerable toxicity in heavily pre-treated, metastatic HER2-negative breast cancer.
DOI:
10.20892/j.issn.2095-3941.2020.0463
