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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial
Published date:
10/31/2023
Excerpt:
Pyrotinib, trastuzumab, and docetaxel showed superiority by significantly improving progression-free survival compared with placebo, trastuzumab, and docetaxel in patients with untreated HER2 positive metastatic breast cancer.
Secondary therapy:
docetaxel
DOI:
10.1136/bmj-2023-076065
Source:
Title:
Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial
Published date:
12/27/2022
Excerpt:
The tpCR rate was 41.0% (95% CI 34.0 to 48.4) in the pyrotinib group compared with 22.0% (95% CI 16.6 to 28.7) in the placebo group (difference, 19.0% [95% CI 9.5 to 28.4]; one-sided P < 0.0001). The objective response rate per investigator was 91.6% (95% CI 86.6 to 94.8) in the pyrotinib group and 81.9% (95% CI 75.6 to 86.9) in the placebo group after the neoadjuvant treatment, resulting in an increase of 9.7% (95% CI 2.7 to 16.6)....Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer.
Secondary therapy:
docetaxel
DOI:
10.1186/s12916-022-02708-3
Trial ID:
Source:
Title:
LBA19 - Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer (PHILA): A randomized phase III trial
Published date:
09/05/2022
Excerpt:
Median follow-up was 15.8 mo and 14.9 mo, respectively. PFS per INV of PyroHT was significantly longer than HT (median, 24.3 mo [95% CI 19.1-33.0] vs 10.4 mo [95% CI 9.3-12.3]; HR, 0.41 [95% CI 0.32-0.53]; P < 0.0001; subgroup results are in Table 1), which was consistent with PFS per IRC (median, 33.0 vs 10.4 mo; HR, 0.35 [95% CI 0.27-0.46]). PyroHT significantly prolonged PFS over HT in pts with HER2-positive mBC. The safety is manageable. To our knowledge, this is the second phase 3 trial to demonstrate PFS benefit from dual HER2 inhibition in 1L treatment of HER2-positive mBC.
Secondary therapy:
docetaxel
Trial ID:
Source:
Title:
Pyrotinib in combination with trastuzumab and docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer (PHEDRA): A randomized, double-blind, multicenter, phase 3 study
Published date:
10/09/2021
Excerpt:
In the full analysis set, IRC-assessed tpCR rates were 41.0% (73 of 178) in the pyrotinib arm and 22.0% (39 of 177)...Pyrotinib, trastuzumab, and docetaxel as neoadjuvant treatment achieved a statistically significant and clinically meaningful improvement in IRC-assessed tpCR rate for patients with HER2-positive early or locally ABC...
Secondary therapy:
docetaxel
Trial ID:
Source:
Title:
Neoadjuvant pyrotinib plus trastuzumab and chemotherapy for stage I-III HER2-positive breast cancer: Results of a single-arm pilot clinical trial
Published date:
11/17/2020
Excerpt:
19 eligible patients were administrated pyrotinib neoadjuvant therapy with epirubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab...The tpCR rate was 72.2% (95% CI: 46.5 - 90.3), and no recurrence or metastasis occurred during the short-term follow-up period...The objective response rate (ORR) was 100% (95% CI: 81.5 - 100) at the end of eighth cycle...HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant...
Secondary therapy:
cyclophosphamide + epirubicin; docetaxel
Source:
Title:
Neoadjuvant chemotherapy with pyrotinib, trastuzumab, docetaxel, and carboplatin in combination for locally advanced epidermal growth factor receptor 2-positve breast cancer: a multicenter, randomized, open-label, parallel-group controlled phase III trial
Excerpt:
......
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+) 5....
Trial ID:
More C2 evidence
Source:
Title:
A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results...
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+) 5....
Trial ID:
Source:
Title:
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC
Excerpt:
...HER2-positive breast cancer; 6....
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+) 5....
Trial ID:
Source:
Title:
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies....
Trial ID:
Source:
Title:
The efficacy and safety of Trastuzumab combined with pyrotinib in neoadjuvant treatment for HER2-positive eraly breast cancer: A real-world study
Excerpt:
...Female breast cancer patients aged ≥18 years old and ≤80 years old; 3.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 4.Patients with breast cancer are eligible: (1) histologically or pathologically diagnosed resectable invasive breast cancer; the primary tumor stage is cT1-4/N0-3/M0 according to standard evaluation at the study site; (2) HER2-positive breast cancer confirmed by a central laboratory and defined as: IHC 3+ in > 10% immunoreactive cells OR c-erbB2 gene amplification by in situ hybridization [ISH] (ratio of c-erbB2 gene signals to centromere 17 signals ≥ 2 or HER 2 gene copy number ≥6); (3) known hormone receptor status (ER and PgR); 5. ...
Trial ID:
Source:
Title:
A Study of Pyrotinib Plus Taxanes or Vinorelbine in Patients With HER2+ Metastatic Breast Cancer Priored Treatment With Trastuzumab
Excerpt:
......
Trial ID:
Source:
Title:
A prospective, open, multi-center clinical study of pyrotinib combined with trastuzumab and nab-paclitaxel in neoadjuvant treatment for stage II-III HER2-positive breast cancer patients
Excerpt:
...Her2-positive breast cancer confirmed by pathology; 6. ...
Trial ID:
Source:
Title:
Neoadjuvant Study With Trastuzumab, Pyrotinib and AI in HER2+ / HR+ Breast Cancer Patients Sensitive to Hormonal Therapy Combined With HER2-Targeted Therapy: an Open-Label, Single-Arm, Multicenter, Phase 2 Trial
Excerpt:
...Pathologically confirmed HER2-positive breast cancer, which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification; 5. ...
Trial ID:
Source:
Title:
Single-Arm, Multi-Center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-Bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
Excerpt:
...Patients with HER2-positive breast cancer confirmed by pathological examination, clinical stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards]; 5. ...
Trial ID:
Source:
Title:
Pyrotinib after trastuzumab-based adjuvant therapy in HER2- positive breast cancer: a single-arm, open, exploratory research
Excerpt:
......
Trial ID:
Source:
Title:
A prospective, open, multicenter, clinical trial for epirubicin, cyclophosphamide, and pyrotinib, sequential docetaxel plus trastuzumab and pyrotinib in the treatment of HER2-positive breast cancer
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+); 5. ...
Trial ID:
Source:
Title:
Efficacy of Pyrotinib combined with trastuzumab and chemotherapy in patients with advanced her-2 positive metastatic breast cancer with or without brain metastasis
Excerpt:
...Advanced or metastatic breast cancer, her-2 positive, positive criteria: FISH method to detect HER-2 gene amplification or immunohistochemical HER-2 3+; 3. ...
Trial ID:
Source:
Title:
Preoperative single arm, multicenter, prospective clinical study of pyrotinib maleate tablets combined with albumin paclitaxel and trastuzumab in the treatment of HER2 positive early or locally advanced breast cancer
Excerpt:
......
Trial ID:
Source:
Title:
A prospective multicenter phase 2 clinical trial: trastuzumab combined pyrotinib and fulvestrant for HR+HER2+ advanced breast cancer after failure of AIs and trastuzumab
Excerpt:
...Histopathologically confirmed HR-positive, HER2-positive breast cancer; (1) ER-positive and/or PR-positive is defined as the proportion of tumor cells with positive staining accounted for all tumor cells >= 10% (reviewed and confirmed by researchers in the test center); (2) HER2-positive is defined as a standard immunohistochemical (IHC) test for HER2 (3+), or HER2 (2+) and a positive FISH test (reviewed and confirmed by an investigator at the testing center); 3. ...
Trial ID:
Source:
Title:
A prospective, single-arm, multicentre clinical study of first-line treatment of her2-positive recurrent/metastatic breast cancer with pyrotinib maleate tablet and trastuzumab plus albumin-bound paclitaxel
Excerpt:
...Patients with recurrent/metastatic breast cancer confirmed by pathological examination with positive HER2 expression; Positive expression of HER2 refers to those whose HER2 is positive by standard immunohistochemical staining (IHC) and/or fluorescence in situ hybridization (FISH) (verified by the researchers in the test center): (1) blood routine examination: neutrophils (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) blood biochemistry: total bilirubin (TBIL) =50%; 8. ...
Trial ID:
Source:
Title:
Prospectiv, open-label, multicenter trial for pyrotinib plus trastuzumab, carboplatin and docetaxel in the treatment of HER2-positive breast cancer
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+); 5. ...
Trial ID:
Source:
Title:
A multicenter, prospective and open clinical study of pyrotinib maleate tablets combined with trastuzumab in adjuvant treatment of HER-2 positive early or locally advanced breast cancer
Excerpt:
......
Trial ID:
Source:
Title:
A multi-center prospective single-arm trial for neoadjuvant chemotherapy with pyrotinib plus trastuzumab for HER2-positive breast cancer
Excerpt:
...Willing to join in the study and agree to use the trastuzumab as the standard scheme for HER2-positive breast cancer and sign the informed consent; 9. ...
Trial ID:
Source:
Title:
Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test; 5....
Trial ID:
Source:
Title:
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
Excerpt:
...Her2-positive breast cancer confirmed by pathology; 3....
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Excerpt:
...- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)...
Trial ID:
Source:
Title:
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Excerpt:
...- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;...
Trial ID:
Source:
Title:
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
Excerpt:
...- Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;...
Trial ID:
Source:
Title:
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
Excerpt:
...HER2 positive breast cancer 3....
Trial ID:
Source:
Title:
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer
Excerpt:
...- For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled; -...
Trial ID:
Source:
Title:
Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Excerpt:
...Pathologically confirmed HER2 positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification 2....
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
Excerpt:
...HER2 positive (HER2+++ by IHC or FISH+) 5....
Trial ID:
Source:
Title:
Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
Excerpt:
...Patients with HER2-positive breast cancer confirmed by pathological examination, clinical stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards]...
Trial ID:
Source:
Title:
Novel Double Target Therapy Combined With Chemotherapy in First-line Treatment of HER2+ Breast Cancer, MA-BC-II-038
Excerpt:
...- Pathologically confirmed diagnosis of Her2-positive advanced or metastatic breast cancer....
Trial ID:
Source:
Title:
Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Excerpt:
...HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2; 3....
Trial ID:
Source:
Title:
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
Excerpt:
...- HER2 positive (HER2+++ by IHC or FISH+)...
Trial ID:
Source:
Title:
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Excerpt:
...- Histologically confirmed invasive HER2 positive breast cancer....
Trial ID:
Source:
Title:
Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
Excerpt:
...- Histologically or cytologic confirmed HER2 positive advanced breast cancer....
Trial ID:
Source:
Title:
Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
Excerpt:
...Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification); 6....
Trial ID:
Source:
Title:
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Excerpt:
...- HER2-positive breast cancer defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization...
Trial ID:
Source:
Title:
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
Excerpt:
...HER2-positive breast cancer; 6....
Trial ID:
Less C2 evidence
Source:
Title:
Real-world data of triplet combination of pyrotinib, trastuzumab, and chemotherapy in HER2-positive metastatic breast cancer: a multicenter, retrospective study
Published date:
12/23/2023
Excerpt:
Patients receiving PyroHC achieved a median PFS of 8.67 months [95% confidence interval (CI): 6.84–10.51] and an ORR of 51.3% (95% CI: 42.1–61.5%). The first-line treatment with PyroHC led to a median PFS of 14.46 months (95% CI: 6.35–22.56).
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.1177/17588359231217972
Trial ID:
Source:
Title:
A multicenter single-arm trial of neoadjuvant pyrotinib and trastuzumab plus chemotherapy for HER2-positive breast cancer
Published date:
12/07/2023
Excerpt:
The objective of this multicenter, single-arm trial (ChiCTR1900022293) was to explore the efficacy and safety of neoadjuvant therapy with epirubicin, cyclophosphamide, and pyrotinib followed by docetaxel, trastuzumab, and pyrotinib (ECPy-THPy) in the treatment of patients with stage II-III HER2-positive breast cancer....The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0) rate in the modified intention-to-treat (mITT) population. In total, 175 patients were included. The tpCR rate was 68.6% (95% CI, 60.7-75.8%), while the objective response rate was 89.1%.
Secondary therapy:
docetaxel + cyclophosphamide + epirubicin
DOI:
10.1002/mco2.435
Source:
Title:
427P - Pyrotinib plus trastuzumab versus pertuzumab plus trastuzumab in patients with HER2-positive metastatic breast cancer: A multicenter, retrospective study
Published date:
10/16/2023
Excerpt:
We retrospectively evaluated medical records for all patients with HER2-positive metastatic breast cancer who received PyroH plus chemotherapy...PyroH demonstrated a longer PFS than HP when taxane was not utilized (median PFS: 10.12 vs. 8.15 months, p=0.017). In patients with brain metastases receiving first-line treatment, PyroH showed a potential advantage over the HP group...In real-world setting, although HP showed unshakable position when combined with taxane in first-line treatment, PyroH presented comparable effectiveness in post second-line treatment and patients with brain metastasis and even better efficacy in patients without combination of taxane.
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Title:
Real-world treatment patterns and outcomes of pyrotinib-based therapy in patients with HER2-positive advanced breast cancer (PRETTY): A nationwide, prospective, observational study
Published date:
08/06/2023
Excerpt:
Dual HER2 blockade with pyrotinib plus trastuzumab showed a mrwPFS of 16.2 months in the total population...In real world, pyrotinib-based therapy shows promising effectiveness in the first-, as well as second- and later-line treatment, with acceptable tolerability.
DOI:
10.1002/ijc.34676
Source:
Title:
Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Published date:
06/09/2023
Excerpt:
In total, 69 female patients were randomized (pyrotinib, 36; and placebo, 33; median age, 53 [31-69] years). In the intention-to-treat population, total pathologic complete response rates were 65.5% (19/29) in the pyrotinib group and 33.3% (10/30) in the placebo group (difference, 32.2%, p = 0.013)....Treatment with pyrotinib, trastuzumab, docetaxel, and carboplatin resulted in a statistically significant improvement in the total pathologic complete response rate versus placebo, trastuzumab, docetaxel, and carboplatin for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer in Chinese patients.
DOI:
https://doi.org/10.1159/000531492
Trial ID:
Source:
Title:
P004 Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer : a multicenter, open-label, phase 2 trial
Published date:
03/15/2023
Excerpt:
Extended adjuvant pyrotinib administrated after trastuzumab-based adjuvant therapy was well-tolerated and showed potential efficacy in high-risk early or locally advanced HER-2 positive breast cancer.
Source:
Title:
Pyrotinib after trastuzumab-based adjuvant therapy in high-risk early human epidermal growth factor receptor 2-positive breast cancer: a multicenter phase 2 trial
Published date:
11/22/2022
Excerpt:
...Two and four patients reported invasive disease events after 6-month and 1-year of follow-up, with the 6- month and 1-year iDFS rates of 98.6% and 97.2%, respectively...Extended adjuvant pyrotinib administrated after trastuzumab-based adjuvant therapy was well-tolerated and showed potential efficacy in high-risk early HER-2 positive breast cancer.
Source:
Title:
Pyrotinib combined with trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer: a single-arm exploratory phase II trial
Published date:
10/30/2022
Excerpt:
The median PFS reached 7.5 months (95% confidence interval [CI] 4.7 to 9.9 months) and 9.4 months (95% CI 6.6 to 12.1 months) in the TP and Sub-BrM, respectively. ORR was 50.5% (20/40). CBR was 75.5% (30/40) and DCR reached 97.5% (39/40)….Pyrotinib plus trastuzumab and chemotherapy offered a promising option with manageable safety profile for heavily pre-treated HER2-positive MBC, especially for those without liver or/and lung metastases.
Secondary therapy:
Chemotherapy
DOI:
10.1007/s10549-022-06770-6
Source:
Title:
Neoadjuvant Efficacy of Three Targeted Therapy Strategies for HER2-Positive Breast Cancer Based on the Same Chemotherapy Regimen
Published date:
09/17/2022
Excerpt:
TCH + Py provides a better pCR rate compared with TCH, and a comparable pCR rate with TCHP among patients with HER2-positive breast cancer in the neoadjuvant setting. The present study supports a novel potential treatment option for these patients. Further studies need to be explored in the future.
Secondary therapy:
carboplatin + docetaxel
DOI:
10.3390/cancers14184508
Source:
Title:
Neoadjuvant Trastuzumab and Pyrotinib for Locally Advanced HER2-Positive Breast Cancer (NeoATP): Primary Analysis of a Phase II Study
Published date:
06/17/2022
Excerpt:
For women with hormone receptor negative and positive tumors, the pCR rates were 85.71% and 59.38% (P = 0.041), while the corresponding rates were 69.23% and 70.00% respectively…The addition of pyrotinib to trastuzumab plus chemotherapy is an efficacious and safe regimen for patients with HER2-positive locally advanced breast cancer...
Secondary therapy:
Chemotherapy
DOI:
10.1158/1078-0432.CCR-22-0446
Source:
Title:
Pathological Response and Predictive Role of TILs in HER2+ Early Breast Cancer Treated With Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy
Published date:
03/15/2022
Excerpt:
In the modified intention-to-treat population (n = 69), 38 patients (55.1%) achieved pCR….Neoadjuvant pyrotinib plus trastuzumab-based chemotherapy exhibits promising efficacy and manageable toxicity in patients with human epidermal growth factor receptor 2-positive early BC...
Source:
Title:
Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel for HER2-positive early or locally advanced breast cancer: an exploratory phase II trial
Published date:
01/01/2022
Excerpt:
The total pCR rate was 57.1% (12/21), whereas 23.8% (5/21) and 19.0% (4/21) of patients had minimal and moderate residual disease (RD), respectively. The ORR reached 100% (21/21) at the end of the neoadjuvant therapy….In women with human epidermal growth factor receptor 2-positive early or locally advanced BC, neoadjuvant pyrotinib plus trastuzumab and albumin-bound paclitaxel effectively promoted total pCR rate with an acceptable safety profile.
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.21037/gs-21-911
Trial ID:
Source:
Title:
Clinical observation of neoadjuvant chemotherapy with pyrotinib plus trastuzumab in HER2-positive breast cancer: a cohort study
Published date:
12/21/2021
Excerpt:
This cohort study included 166 patients with HER2-positive breast cancer...The total pathological complete response (tpCR) rate of Group I was 63.49% (40/63); the breast pathological complete response (bpCR) rate was 76.19% (48/63); and the objective response rate (ORR) was 100% (63/63)....Hormone receptor (HR)-negative patients were more likely to reach tpCR as compared to HR-positive patients (61.54% vs. 37.50%, P=0.002, 95% CI: 1.423 to 4.997)...Pyrotinib plus trastuzumab combined with neoadjuvant chemotherapy showed good short-term efficacy in HER2-positive breast cancer...
DOI:
10.21037/gs-21-794
Source:
Title:
First-line pyrotinib plus trastuzumab and nab-paclitaxel for patients with HER2-positive advanced breast cancer
Published date:
09/10/2021
Excerpt:
Pyrotinib plus trastuzumab and nab-paclitaxel showed promising efficacy in first-line HER2-positive breast cancer and were well tolerated. More data would be analyzed and reported in the future.
Secondary therapy:
paclitaxel
Source:
Title:
A prospective, open, multi-center clinical study of pyrotinib combined with trastuzumab and nab-paclitaxel in neoadjuvant treatment for stage II-III HER2-positive breast cancer patients
Published date:
09/10/2021
Excerpt:
Pyrotinib combined with trastuzumab and nab-paclitaxel in neoadjuvanttreatment for pts with stage II-III HER2-positive breast cancer showedacceptable toxicity and promising efficacy.
Secondary therapy:
paclitaxel
Source:
Title:
Pyrotinib as neoadjuvant therapy for HER2+ breast cancer: A multicenter, randomized, controlled, phase II trial.
Published date:
05/19/2021
Excerpt:
Eligible patients (pts) aged 18–70 years with invasive carcinoma, cT2-3N0-3M0 stage, HER2-positive breast cancer were included...Pts in the treatment group received 6 cycles of pyrotinib 400mg + trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m2 + carboplatin (AUC = 6mg/ml·min) (TCbH+Py) treatment...In this study TCbH+Py neoadjuvant therapy significantly improved the tpCR rate of HER2+ breast cancer pts for about twice higher than TCbH with a manageable safety.
Secondary therapy:
carboplatin; docetaxel
DOI:
10.1200/JCO.2021.39.15_suppl.574
Trial ID:
Source:
Title:
225P - Phase II study of pyrotinib plus albumin-bound paclitaxel and trastuzumab as neoadjuvant treatment in HER2-positive early or locally advanced breast cancer
Published date:
09/14/2020
Excerpt:
In women with HER2-positive early or locally advanced BC, the neoadjuvant regimen pyrotinib plus albumin-bound paclitaxel and trastuzumab effectively promoted pCR of tumor and presented an acceptable tolerability.
Secondary therapy:
albumin-bound paclitaxel
Trial ID:
Source:
Title:
Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study
Excerpt:
Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab were assigned (1:1) to receive 400 mg pyrotinib or lapatinib 1,250 mg orally once per day for 21-day cycles in combination with capecitabine (1,000 mg/m2 orally twice per day on days 1 to 14). The overall response rate was 78.5% (95% CI, 68.5% to 88.5%) with pyrotinib and 57.1% (95% CI, 44.9% to 69.4%) with lapatinib (treatment difference, 21.3%; 95% CI, 4.0% to 38.7%; P = .01).
Secondary therapy:
capecitabine
DOI:
10.1200/JCO.19.00108
Source:
Title:
HER2-positive metastatic breast cancer with brain metastases responds favorably to pyrotinib and trastuzumab-based treatment: A case report and literature review
Published date:
01/19/2023
Excerpt:
We herein reported a case of a female patient who was initially diagnosed with HER2-positive metastatic breast cancer with brain metastases, receiving pyrotinib and trastuzumab-based systematic therapy after palliative craniocerebral radiotherapy as the first-line systematic therapy....The patient continued receiving trastuzumab and pyrotinib for HER2-targeted therapy. She had achieved more than 26 months of progression-free survival and the disease was stable during the evaluation in April 2022.
DOI:
10.3389/fonc.2022.980635
Source:
Title:
The successful application of pyrotinib in the treatment of primary trastuzumab-resistant HER-2-positive breast cancer with bilateral axillary lymph node metastasis: a case report
Excerpt:
...a 47-year-old woman diagnosed with HER-2 positive breast cancer with regional lymph nodes metastasis...The patient received trastuzumab-based treatment, but this only afforded a progression-free survival of 5 months, owing to primary trastuzumab resistance. She was then successfully treated with pyrotinib, and the outcome was close to clinical complete response (CCR) with a progression-free survival of over 27 months thus far. This case report may help inform clinicians in the diagnosis of breast cancer with CAM and offer the treatment options in HER-2-positive metastasis breast cancer with primary trastuzumab resistance.
DOI:
10.21037/apm-21-1364