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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update

Published date:
05/31/2022
Excerpt:
If a patient's HER2-positive advanced breast cancer has progressed during or after second-line or greater HER2-targeted treatment...Recommendation…May offer lapatinib and capecitabine…
Secondary therapy:
capecitabine
DOI:
10.1200/JCO.22.00519
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Invasive Breast Cancer: HER2 positive...Other recommended regimens…Lapatinib + capecitabine…Aromatase inhibitor ± lapatinib.
Secondary therapy:
Aromatase inhibitor; capecitabine
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer

Excerpt:
HER2-positive breast cancer...Recommendations...Second-line treatment...Neratinib...and margetuximab...can be considered reasonable approaches in the late-line scenario.
DOI:
https://doi.org/10.1016/j.annonc.2021.09.019.
Evidence Level:
Sensitive: B - Late Trials
Title:

Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer

Published date:
01/09/2023
Excerpt:
Ten-year OS rates were 76% (95% CI, 67%–83%), 75% (95% CI, 66%–82%) and 80% (95% CI, 73%–86%) in the lapatinib, trastuzumab and combination groups, respectively….Patients with HER2-positive BC showed a durable survival benefit of neoadjuvant anti-HER2, irrespective of treatment arm. Patients who achieve pCR have significantly better outcomes than patients without pCR.
DOI:
https://doi.org/10.1016/j.ejca.2022.12.020
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

221P - Long-term outcomes of patients with node-negative, <=3cm, HER2+ breast cancer (BC) enrolled in ALTTO

Published date:
09/14/2020
Excerpt:
ALTTO was a large phase III study evaluating the addition of lapatinib (L) to T for early-stage HER2+ BC pts…As such, for pts under concomitant CT (N=1235), 96 DFS events occurred for 7y DFS rates of 84% (95% CI [77-90]), 91% (86-94), 93% (89-96), and 89% (83-93) in L, T, T+L, and T⟶L, respectively (p=0.038).
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer

Excerpt:
The interim analysis of time to progression met specified criteria for early reporting on the basis of superiority in the combination-therapy group….Lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.
Secondary therapy:
capecitabine
DOI:
10.1056/NEJMoa064320
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses

Excerpt:
The addition of lapatinib prolonged TTP with a hazard ratio (HR) of 0.57 (95% CI, 0.43–0.77; P < 0.001) and provided a trend toward improved overall survival (HR: 0.78, 95% CI: 0.55–1.12, P = 0.177)….The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy.
Secondary therapy:
capecitabine
DOI:
10.1007/s10549-007-9885-0
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A PHASE II STUDY OF GW572016 LAPATINIBTM ON CELL PROLIFERATION IN HER-2/neu ErbB2 POSITIVE BREAST CANCER BEFORE SURGERY.

Excerpt:
...Histologically-confirmed HER 2 positive ErbB-2 3 , regardless of the FISH results, or 2 with FISH positive . ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

The Myocet/Lapatinib Study. ICORG 10-03, V5

Excerpt:
...Determination of the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes as measured by MTD (Phase I)`Optimal dose for lapatinib plus myocet...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases

Excerpt:
...Patients with HER2-positive MBC and unequivocal evidence of brain metastases....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

Excerpt:
...Advance breast cancer with her2 positive 2....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

INST 0514C- Biologic Correlative Study: Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients

Excerpt:
...HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >5 (in Dr. ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells

Excerpt:
...Evidence of EGFR positive circulating tumour cells or HER-2 positive (≥50% CTCs or FISH positive) in a peripheral blood sample taken at screening visit.5. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Lapatinib Resistance in Patients With Breast Cancer

Excerpt:
...- ErbB2-positive disease...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Excerpt:
...The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery

Excerpt:
...- Patients must have histologically confirmed HER2-positive invasive breast, gastric, or gastroesophageal carcinoma that is locally advanced and unresectable or metastatic and for which standard curative or palliative measures do...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadjuvant GW572016 to Treat Breast Cancer

Excerpt:
...HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >/- 5 (in Dr. ...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Concurrent lapatinib with brain radiotherapy in HER2+ breast cancer patients with brain metastases - NRG ONCOLOGY-KROG/ RTOG 1119 phase II randomized trial

Published date:
07/26/2023
Excerpt:
This study included HER2+ breast cancer patients with ≥1 measurable, unirradiated BM. Patients were randomized to WBRT (37.5 Gy/3 weeks)/ SRS (size-based dosing) +/- concurrent lapatinib...At 4 weeks, RT+lapatinib showed higher ORR (55% vs. 42%)....Adding lapatinib to WBRT/SRS showed improvement of 4-week ORR suggesting a short-term benefit from concomitant therapy.
DOI:
https://doi.org/10.1016/j.ijrobp.2023.07.019
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Prognostic Factors Influencing Progression-Free Survival in HER2-Positive Metastatic Breast Cancer Patients Who Were Treated With A Combination of Lapatinib and Capecitabine

Published date:
04/01/2023
Excerpt:
With combined lapatinib and capecitabine, complete response was observed in 7.8%, partial response in 30.4%, and stable disease in 24.5%....These results have demonstrated the effectiveness of lapatinib plus capecitabine in metastatic HER2-positive breast cancer patients.
Secondary therapy:
capecitabine
DOI:
10.4274/ejbh.galenos.2023.2022-12-4
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Outcomes of patients with HER2 positive metastatic breast cancer treated with low dose or metronomic lapatinib

Published date:
11/28/2022
Excerpt:
The median number of lines of treatment before lapatinib was one. Lapatinib was given in combination, but 4 patients received it as a single agent. The disease control rate with lapatinib was 61.7%, out of whom 4.3% (n=2) experienced complete remission. The median progression free survival was 7 months (95% CI: 5.6 - 8.4 months), with a median overall survival of 12.5 months (95% CI: 9.7 - 15.3 months). The median duration of response was 4.5 months, ranging from 1.3 months to 45.8 months. The low-dose lapatinib was well-tolerated...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Prognostic factors influencing progression-free survival in HER2 positive metastatic breast cancer patients who treated with lapatinib and capecitabine combination.

Published date:
05/26/2022
Excerpt:
We evaluated data of the HER2 positive metastatic breast cancer patients who were treated with lapatinib and capecitabine retrospectively….Complete response was 8.2%, partial response 32%, and stable disease 25.8% with lapatinib and capecitabine combinations. At a median follow of 11.6 months, progression-free survival was 8 (95% CI, 5.1-10.8) months. In multivariate analysis, age (p = 0.020), de-novo metastatic disease (p = 0.028), and endocrine therapy (p = 0.020) were statistically significant prognostic factors for progression-free survival....We showed real-life outcomes of the lapatinib and capecitabine combination in metastatic HER2-positive breast cancer patients.
Secondary therapy:
capecitabine
DOI:
10.1200/JCO.2022.40.16_suppl.e13031
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: a phase II, multicenter, single-arm study (SYSUCC-005)

Published date:
03/15/2022
Excerpt:
Patients with HER2-positive metastatic breast cancer rapidly progressing during pre-trastuzumab from six hospitals in China were designed to switch to lapatinib 1,250 mg orally once per day continuously plus capecitabine (1,000 mg/m2 orally twice per day on days 1-14) or vinorelbine...The median follow-up was 33.1 months, a median PFS of 8.5 months was achieved….The switching mode showed predominant efficacy, which might be a prior therapeutic option over continuing mode in subsequent anti-HER2 therapy for patients with HER2-positive refractory metastatic breast cancer.
Secondary therapy:
vinorelbine; capecitabine
DOI:
10.1186/s12885-022-09399-2
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Experience on the diagnosis and treatment of multiple active primary cancers in our Institution

Published date:
05/19/2021
Excerpt:
Six MAPC patients including 1 ROS-1 rearranged lung cancer, 4 EGFR mutant lung cancer, and 2 HER2 positive breast cancer were treated with corresponding targeted agents (crizotinib, gefitinib and lapatinib). Four responses (1 CR and 3 PR) and 2 stable disease (PFS 33+ and 132 months) were observed. Three of the four responders had a PFS of 1+, 29+ and 27 months...
DOI:
10.1200/JCO.2021.39.15_suppl.e15097
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy of lapatinib combined with capecitabine in patients with HER2-positive metastatic breast cancer in a real-world study

Published date:
10/22/2020
Excerpt:
The aim of the present real-world study was to investigate the medical records and follow-up information of 92 patients with HER2+ MBC who received a lapatinib-based regimen at the recurrent/metastatic stage...the findings of the present study suggested that lapatinib-based treatment is effective in patients with HER2+ MBC (even in trastuzumab-pretreated patients), and the combination of lapatinib with capecitabine may be recommended due to its good efficacy, convenience and tolerability.
Secondary therapy:
capecitabine
DOI:
10.3892/ol.2020.12241
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)

Published date:
11/06/2019
Excerpt:
The median number of previous anti-HER2 therapies was 2 (range 2-5). Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib.
Secondary therapy:
vinorelbine tartrate
DOI:
10.1038/s41416-019-0618-z
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

All-oral combination of lapatinib and capecitabine in patients with brain metastases from HER2-positive breast cancer – A phase II study

Excerpt:
The overall response rate (ORR) was 33.3% (7/21) and all were partial response. For patients receiving prior WBRT and patients receiving LC as first line treatment for BCBM the ORR was 31.2% (5/16) and 40.0% (2/5) respectively. Median PFS was 5.5 months. Median OS was 11 months....The combination of LC is active and well-tolerated treatment in patients with HER2+ve BCBM.
Secondary therapy:
capecitabine
DOI:
https://doi.org/10.1016/j.jnci.2014.08.001
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

The efficacy of lapatinib in patients with metastatic HER2 positive breast cancer who received prior therapy with monoclonal antibodies and antibody-drug conjugate: a single institutional experience

Excerpt:
The aim of this research is to determine efficacy of lapatinib in this setting. This research included 111 patients with metastatic HER2 positive breast cancer who received lapatinib with capecitabine...Median PFS was 5.6 months (95% CI 4.6-6.6) in the group of patients who received lapatinib after prior exposure to trastuzumab, pertuzumab and/or T-DM 1 and 7.4 months (95% CI 6.1-10.2) in the group of patients who received lapatinib after trastuzumab (HR, 0.79; 95% CI 0.61-0.98; P = 0.09).
Secondary therapy:
capecitabine
DOI:
https://doi.org/10.1080/1120009X.2021.2009722
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Human induced pluripotent stem cell-derived platelets loaded with lapatinib effectively target HER2+ breast cancer metastasis to the brain

Published date:
10/15/2021
Excerpt:
...BBM1 lines established from HER2+ patient-derived BBM tumors...We also observed significantly reduced viability of BBM cells exposed to a 1:1 mixture of lapatinib…
DOI:
https://doi.org/10.1038/s41598-021-96351-2
Evidence Level:
Sensitive: D – Preclinical
Title:

Comparative analysis of drug response and gene profiling of HER2-targeted tyrosine kinase inhibitors

Published date:
01/21/2021
Excerpt:
CONTRADICTING EVIDENCE:...The anti-proliferative effects of neratinib, lapatinib, and tucatinib were examined across a panel of 115 cancer cell lines...The MDA-MB-453 cell line was the only HER2+ cell line that had a poor response to each TKI.
DOI:
10.1038/s41416-020-01257-x