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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Halaven (eribulin mesylate) (Microtubule inhibitor, CBP inhibitor, β-catenin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Invasive Breast Cancer: HER-2 negative...Preferred regimens…Microtubule inhibitors…Eribulin...
Source:
Title:
Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer
Excerpt:
...HER2-negative breast cancer 3....
Trial ID:
Source:
Title:
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
Excerpt:
...HER2-negative as determined by fluorescence in situ hybridization (FISH); or 0 or 1+ by immunohistochemistry (IHC) staining ....
Trial ID:
More C2 evidence
Source:
Title:
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
Excerpt:
...Patients with HER2-negative inoperable or recurrent breast cancer....
Trial ID:
Source:
Title:
Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer
Excerpt:
...- HER2-negative BC (as per local assessment), defined as either of the following:...
Trial ID:
Source:
Title:
Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer
Excerpt:
...- Invasive breast cancer must be Her2-negative....
Trial ID:
Source:
Title:
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
Excerpt:
...To evaluate the pathologic complete response (pCR) rate following neoadjuvant treatment with four cycles of Doxorubicin and Cyclophosphamide (AC) and four cycles of Eribulin mesylate chemotherapy in HER2-negative operable breast cancer.`...
Trial ID:
Source:
Title:
Multicenter, randomized study of eribulin plus capecitabine versus capecitabine in HER2-negative patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes
Excerpt:
...HER2-negative confirmed by a local laboratory; 4. ...
Trial ID:
Source:
Title:
Gemcitabine and Eribulin as first line treatment of advanced triple-negative breast cancer. Gemcitabina ed Eribulina come trattamento di prima linea nel carcinoma mammario triplo-negativo in fase avanzata.
Excerpt:
...Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or, e.g. in HER2 2+ cases, fluorescent in situ hybridization (FISH) < ratio of 1.8. ...
Trial ID:
Source:
Title:
Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
Excerpt:
...Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative)....
Trial ID:
Source:
Title:
Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer
Excerpt:
...Bilateral, synchronous breast cancer is allowed if both primary tumors are HER2-negative and at least one meets the specified qualifying tumor or nodal...
Trial ID:
Source:
Title:
Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment
Excerpt:
...- Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV...
Trial ID:
Source:
Title:
Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients
Excerpt:
...- The patient was diagnosed as triple-negative breast cancer by histopathology (ER negative (IHC ER positive percentage <1%), PR negative (IHC PR positive percentage <1%), HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is...
Trial ID:
Source:
Title:
AIRE: Investigation of the immune response after chemotherapy treatment with Eribulin: A trial for female patients with advanced breast cancer. AIRE: Untersuchung der Immunantwort nach Behandlung mit der Chemotherapie Eribulin: Eine Studie für Patientinnen mit fortgeschrittenem Brustkrebs.
Excerpt:
...Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. ...
Trial ID:
Source:
Title:
Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Breast Cancer (MBC) patients: a randomized phase II study – ERICA trial ERIbulina in seconda linea seguita da CApecitabina o sequenza inversa in pazienti con carcinoma mammario metastatico (MBC) HER2-negativo: uno studio randomizzato di fase II – Studio ERICA
Excerpt:
...Histological diagnosis of HER2 negative MBC;3. ...
Trial ID:
Source:
Title:
Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients
Excerpt:
...- Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or fluorescent in situ hybridization (FISH) < ratio of 1.8...
Trial ID:
Source:
Title:
Clinical Trial to study the effect of the treatment with eribulin and endocrine therapy in metastatic breast cancer patients Ensayo clínico para estudiar el efecto de tratamiento con eribulina y terapia endocrina en pacientes con cáncer de mama avanzado
Excerpt:
...Patients with HER2-negative breast cancer through in situ hybridization test (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver enhanced in situ hybridization [SISH]) or negative immunohistochemical status of 0 or 1+. ...
Trial ID:
Source:
Title:
Eribulin in Brain Metastases From HER2-negative Breast Cancer
Excerpt:
...HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer 5....
Trial ID:
Source:
Title:
Eribulin in HER2 Negative Metastatic BrCa
Excerpt:
...- Hormone receptor positive or hormone receptor negative HER2-negative disease...
Trial ID:
Source:
Title:
Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer
Excerpt:
...- Documentation of HER2 negative breast cancer at the time of protocol registration; (...
Trial ID:
Source:
Title:
A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).
Excerpt:
...The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］....
Trial ID:
Source:
Title:
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
Excerpt:
...Females age 18 years or older at the time of informed consent Have histologically or cytologically proven adenocarcinoma of the breast Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1 Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining....
Trial ID:
Source:
Title:
Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer Patients
Excerpt:
...- Histological diagnosis of HER2 negative MBC...
Trial ID:
Source:
Title:
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer
Excerpt:
...- Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion....
Trial ID:
Source:
Title:
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
Excerpt:
...The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］....
Trial ID:
Source:
Title:
Gemcitabine Combined With Eribulin Regimen in the Treatment of Second-line Above Recurrent HER2-negative Breast Cancer
Excerpt:
...Histologically diagnosed histological examination confirmed breast cancer patients with locally advanced or metastatic HER2-negative (expression lack of human epidermal growth factor 2 (HER2) confirmed by central laboratory examination) and unsuitable for surgical treatment; 2....
Trial ID:
Source:
Title:
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
Excerpt:
...- HER2-negative breast cancer....
Trial ID:
Source:
Title:
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer
Excerpt:
...Patients with HER2-negative disease confirmed as ISH negative or IHC 0, 1+ or 2+ (Those with IHC 2+ are eligible, if the additional ISH test results are negative....
Trial ID:
Less C2 evidence
Source:
Title:
Eribulin combined with antiangiogenic agents in women with HER2-negative metastatic breast cancer: a retrospective multicenter study
Published date:
10/11/2023
Excerpt:
A total of 85 consecutive MBC patients with HER2-negative who were treated with eribulin + antiangiogenic agents...The ORR and DCR were 34.1% (29/85) and 75.3% (64/85). The median PFS (mPFS) of total population was 6.0 months (95% CI: 4.3-7.7), and median OS (mOS) was immature. The mPFS was 7.7 and 4.3 months in the first to second and greater than or equal to third line treatment (p = 0.003), respectively.
Source:
Title:
Efficacy and safety of eribulin plus gemcitabine in second-line or beyond for patients with HER2-negative metastatic breast cancer: A multi-center, open-label, single-arm, phase II study.
Published date:
05/25/2023
Excerpt:
The median number of previous chemotherapy lines was 3 (range: 2-7): eribulin plus gemcitabine was used in second-line for 15 (27.8%) patients, third-line for 20 (37.0%) patients, fourth-line for 7 (13.0%) patients and ≥fifth-line in 12 (22.2%) patients. The median PFS was 7.7 months. The ORR was 40.7% and the DCR was 66.7%. Best overall responses and PFS rates at 3 and 6 months are shown...Eribulin plus gemcitabine is effective in heavily pretreated patients with HER2-negative MBC with a predictable, manageable safety profile.
Secondary therapy:
gemcitabine
DOI:
10.1200/JCO.2023.41.16_suppl.e13102
Trial ID:
Source:
Title:
Prognosis factors for long-term eribulin response in a cohort of patients with HER2-negative metastatic breast cancer.
Published date:
05/25/2023
Excerpt:
Our retrospective cohort include female patients with HER2-negative metastatic breast cancer treated with eribulin...Median progression free survival (PFS) is 3.2 months. 23.6 percent of patients have a long-term response to eribulin. Four discriminant criteria appear to separate progression free survival in two arms (PFS < 3 months or > 6 months) predicting nearly 78% the probability of a prolonged response to eribulin...Median overall survival is 8.5 months...
DOI:
10.1200/JCO.2023.41.16_suppl.e13120
Source:
Title:
Eribulin improved the overall survival from the initiation of first-line chemotherapy for HER2-negative advanced breast cancer: a multicenter retrospective study
Published date:
01/03/2022
Excerpt:
...in patients who received eribulin in later lines (≥3rd-line) and who had a history of perioperative chemotherapy with anthracycline- and/or taxane-based regimens, the median OS improved (1001 vs. 744 days, P = 0.037; and 834 vs. 464 days, respectively P = 0.032, respectively; Wilcoxon)....This study successfully identified subgroups of HER2− ABC patients with improved OS by eribulin therapy.
DOI:
https://doi.org/10.1186/s12885-021-09137-0
Source:
Title:
Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19)
Published date:
04/23/2021
Excerpt:
Patients with recurrent HER2-negative BC...Patients were randomized 1:1 by the minimization method to receive either eribulin (1.4 mg/m2 on day one and eight of each 21-day cycle) or TPC (paclitaxel, docetaxel, nab-paclitaxel or vinorelbine)....Patients were randomized 1:1 by the minimization method to receive either eribulin (1.4 mg/m2 on day one and eight of each 21-day cycle) or TPC (paclitaxel, docetaxel, nab-paclitaxel or vinorelbine).
DOI:
10.1007/s10147-021-01920-0
Source:
Title:
Single arm, phase two study of low-dose metronomic eribulin in metastatic breast cancer
Published date:
04/02/2021
Excerpt:
All patients were treated with metronomic eribulin (0.9 mg/m2 administered intravenously on days 1, 8, and 15 of a 28-day cycle....We consented 86 patients and 59 were evaluable for final analysis. Median age was 59 years; 78% had HER2 negative tumors. The median progression-free survival (PFS) was 3.5 months with overall survival (OS) of 14.3 months. Objective response rate was 15% with clinical benefit rate of 48%.
DOI:
10.1007/s10549-021-06175-x
Source:
Title:
A phase II, multicenter, single-arm trial of eribulin as first or second line chemotherapy for HER2-negative advanced or metastatic breast cancer: Evaluation of efficacy, safety, and patient-reported outcomes.
Published date:
05/16/2018
Excerpt:
A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off: July 31, 2017). The ORR was 37.1% (95% CI 21.1%–53.2%). The clinical benefit rate was 54.3% (95% CI 37.8%–70.8%). The median PFS was 6.2 months (95% CI 2.7–9.4 months) and median OS was 21.4 months (95% CI 11.5–32.9 months)...Eribulin as first- or second-line chemotherapy is effective and has manageable tolerability for patients with HER2-negative MBC.
DOI:
10.1200/JCO.2018.36.15_suppl.e13059
