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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | albumin-bound paclitaxel (Bcl2 inhibitor, Tubulin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Invasive Breast Cancer: HER-2 negative...Other Recommended Regimens…Albumin-bound paclitaxel…
Source:
Title:
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer
Excerpt:
...histologically confirmed recurrent or metastatic breast cancer, ER-positive (> 10%), HER-2 negative (...
Trial ID:
Source:
Title:
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
Excerpt:
...Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology...
Trial ID:
More C2 evidence
Source:
Title:
Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer
Excerpt:
...- 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...
Trial ID:
Source:
Title:
Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
Excerpt:
...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....
Trial ID:
Source:
Title:
Anti human PD-L1 monoclonal antibody (HS636) monotherapy and combined with albumin bound paclitaxel in the treatment of advanced triple negative breast cancer (TNBC): a phase Ib /II clinical trial
Excerpt:
......
Trial ID:
Source:
Title:
PHASE I-II STUDY OF THE ASSOCIATION OF TAXOLO BOUND TO ALBUMNI AND LIPOSOMIAL ANTHRACYCLINE FOR THE TREATMENT OF ADVANCED BREAST CANCER STUDIO DI FASE I-II CON L'ASSOCIAZIONE DI TAXOLO LEGATO AD ALBUMINA E ANTRACICLINA LIPOSOMIALE PER IL TRATTAMENTO DEL TUMORE DELLA MAMMELLA IN FASE AVANZATA
Excerpt:
...• 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). ...
Trial ID:
Source:
Title:
A single-arm, multicenter, prospective, phase II clinical study of camrelizumab combined with anlotinib hydrochloride and albumin paclitaxel in the first-line treatment of advanced triple-negative breast cancer
Excerpt:
......
Trial ID:
Source:
Title:
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Excerpt:
...- Histologically documented Her-2 negative -...
Trial ID:
Source:
Title:
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Excerpt:
...- HER2/neu-negative....
Trial ID:
Source:
Title:
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
Excerpt:
...- 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;...
Trial ID:
Source:
Title:
Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
Excerpt:
...HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative); 4....
Trial ID:
Source:
Title:
Study of Nab-Paclitaxel in High Risk Early Breast Cancer
Excerpt:
...- Luminal B-like tumors (ER and/or PgR positive, HER2 negative, Ki-67 > 20%) with involved lymph nodes or...
Trial ID:
Source:
Title:
A single-arm, multicenter, prospective, phase II clinical study of AK105 combined with anlotinib hydrochloride and nab-paclitaxel in the first-line treatment of advanced triple-negative breast cancer
Excerpt:
......
Trial ID:
Source:
Title:
Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer
Excerpt:
...Patients with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. ...
Trial ID:
Source:
Title:
Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice
Excerpt:
...- HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer....
Trial ID:
Source:
Title:
Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
Excerpt:
...- Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer....
Trial ID:
Source:
Title:
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer
Excerpt:
...- HER2-negative disease...
Trial ID:
Source:
Title:
Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
Excerpt:
...- Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer....
Trial ID:
Source:
Title:
Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study
Published date:
10/26/2023
Excerpt:
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...
DOI:
10.1093/oncolo/oyad288
Trial ID:
Source:
Title:
Phase II randomized trial of different nab-paclitaxel dose schedule in patients with HER-2 negative recurrent/metastatic breast cancer.
Published date:
05/26/2022
Excerpt:
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.
DOI:
10.1200/JCO.2022.40.16_suppl.e13050
Trial ID:
Source:
Title:
Efficacy and Safety of Albumin-Bound Paclitaxel Compared to Docetaxel as Neoadjuvant Chemotherapy for HER2-Negative Breast Cancer
Published date:
01/11/2022
Excerpt:
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.
DOI:
https://doi.org/10.3389/fonc.2021.760655
Source:
Title:
Efficacy and safety of albumin-bound paclitaxel compared to docetaxel as neoadjuvant chemotherapy for HER2-negative breast cancer
Published date:
12/13/2021
Excerpt:
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).
Source:
Title:
Feasibility Study of Nanoparticle Albumin-Bound-Paclitaxel and S-1 Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With Operable Breast Cancer: A Prospective Study
Published date:
07/18/2021
Excerpt:
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.
DOI:
10.1016/j.clbc.2021.06.006
Source:
Title:
Safety and Efficacy of Low-dose Nanoparticle Albumin-bound Paclitaxel for HER2-negative Metastatic Breast Cancer
Excerpt:
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)...
DOI:
10.21873/anticanres.12233
Source:
Title:
Efficacy and safety of nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy in HER2-negative breast cancer
Excerpt:
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).
DOI:
10.4103/jcrt.JCRT_241_19
