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Association details:
| Biomarker: | HR negative |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Randomised, open-label phase II study to compare the safety and efficacy of lapatinib plus trastuzumab or lapatinib plus capecitabine in trastuzumab-resistant HER2-overexpressing metastatic breast cancer Randomisierte, offene Studie der Phase II zum Vergleich der Sicherheit und Wirksamkeit von Lapatinib plus Trastuzumab oder Lapatinib plus Capecitabin bei Trastuzumab-resistentem, HER2-positivem metastasierendem Brustkrebs
Excerpt:
...Women with histologically confirmed breast cancer; measurable metastatic disease; HER2-positive (IHC 3+ or ISH positive); Hormone receptor-negative; prior treatment with trastuzumab, anthracycline and taxanes; progression on trastuzumab as first-line or second-line therapy; no prior treatment with lapatinib within last 6 months; Adequate hematologic, renal and liver function; normal cardiac function with LVEF of ≥50%; ECOG performance status 0-1; No evidence of brain metastases (asymptomatic metastases that have been clinically stable for 3 months are allowed); no significant cardiovascular disease or other serious medical condition; written informed consent to participate in the trial and to the donation of formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer available for central testing....
Trial ID:
Source:
Title:
Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer
Excerpt:
...- Hormone receptor negativity ( 2.2; in case of polysomy, with ≥ 6 gene copies])...
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and safety of PI3K/Akt/mTOR inhibitors combined with trastuzumab therapy for HER2-positive breast cancer: a meta-analysis
Published date:
10/01/2022
Excerpt:
This randomized controlled trial (RCTs) meta-analysis was designed to evaluate the clinical efficacy and safety of PI3K/Akt/mTOR inhibitors in combination with trastuzumab in HER2-positive breast cancer….PI3K/Akt/mTOR inhibitors combination with trastuzumab treatments resulted in a statistically significant increase in PFS compared with conventional trastuzumab therapy (HR 0.82; 95% CI: 0.76-0.90; p<0.00001). The new combination treatment was more effective on hormone receptor-negative patients (HR 0.73; 95% CI: 0.58-0.93; p=0.010).
Secondary therapy:
inhibitors of the PI3K/AKT/mTOR pathway
DOI:
10.26355/eurrev_202210_30043
Source:
Title:
The Role of Trastuzumab in Patients with HER2 Positive Small (pT1mi/a) Breast Cancers, a Multicenter Retrospective Study
Published date:
11/21/2021
Excerpt:
Disease recurrence rate was significantly lower among patients who received adjuvant Trastuzumab (p = 0.02), with this therapy conferring an 85% reduction in the risk of relapse (HR 0.15; p = 0.02)….Adjuvant Trastuzumab appears to reduce the risk of disease recurrence even in small HER2+ tumors. The adjuvant targeted therapy should be considered in patients with HR− HER2+ tumors since they have the highest risk of recurrence, independently from size and grade.
DOI:
https://doi.org/10.3390/cancers13225836
Source:
Title:
Evaluation of a proposed trastuzumab biosimilar compared with trastuzumab in neoadjuvant breast cancer treatment
Published date:
12/04/2020
Excerpt:
Sixteen patients had HER2 positive, hormone receptor (HR) positive tumors and 6 patients a HER2 positive, HR negative tumors….patients treated with neoadjuvant therapy with trastuzumab (proposed biosimilar or trastuzumab)...Breast pCR was achieved in 86% (n=6) and 33% (n=5) in trastuzumab and proposed biosimilar groups respectively.
DOI:
10.1136/ijgc-2020-ESGO.1
Source:
Title:
Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07)
Published date:
11/17/2020
Excerpt:
In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with funding provided by Sanofi and GlaxoSmithKline (TRIO-US B07, Clinical Trials NCT00769470), participants with early-stage HER2-positive breast cancer (N = 128) were recruited...Participants were randomized to receive trastuzumab (T; N = 34), lapatinib (L; N = 36), or both (TL; N = 58) as HER2-targeted therapy...we observed similar pCR rates between T (47%, 95% confidence interval [CI] 30-65%) and TL (52%, 95% CI 38-65%), and a lower pCR rate with L (25%, 95% CI 13-43%)...Higher-level amplification of HER2 and hormone receptor (HR)-negative status were associated with a higher pCR rate.
DOI:
10.1038/s41467-020-19494-2
Trial ID:
Source:
Title:
Therapeutic Effect of Trastuzumab in Neoadjuvant-Treated HER2-Positive Breast Cancer with Low Infiltrating Level of Tumor-Infiltrating Lymphocytes
Published date:
05/05/2020
Excerpt:
HR-negative status and histological grade 3 were independently associated with higher pCR rates, and pCR was the only independent predictor for improved survival.
DOI:
10.2147/CMAR.S248071
