Illustration of HER2-positive breast cancer cells being targeted by combined therapy, overcoming resistance.

HER2+ Breast Cancer Breakthrough: Can a New Combo Overcome Treatment Resistance?

"A Phase I study reveals how adding dasatinib to trastuzumab and paclitaxel shows promise in fighting HER2-overexpressing breast cancer by targeting resistance mechanisms."


Personalized medicine is revolutionizing cancer treatment by targeting specific vulnerabilities in tumors. A prime example is the development of anti-HER2 therapies, which have significantly improved outcomes for patients with HER2-overexpressing breast cancers. Trastuzumab, a monoclonal antibody, has become a cornerstone of treatment, but resistance remains a major challenge.

While trastuzumab offers undeniable benefits, most patients with HER2-positive metastatic tumors eventually experience disease progression. This has spurred the development of novel agents like lapatinib, pertuzumab, and T-DM1. However, understanding and overcoming resistance mechanisms is crucial to further improve outcomes.

Researchers have identified several mechanisms that contribute to trastuzumab resistance, including the activation of alternative signaling pathways and intrinsic changes in the HER2 receptor itself. Among these, the activation of the cytosolic kinase SRC has emerged as a key player. A new study explores whether combining dasatinib, an SRC kinase inhibitor, with trastuzumab and paclitaxel can improve outcomes in patients with HER2-overexpressing breast cancer.

Dasatinib: A New Weapon Against Trastuzumab Resistance?

Illustration of HER2-positive breast cancer cells being targeted by combined therapy, overcoming resistance.

Preclinical studies suggest that SRC inhibition can enhance trastuzumab activity. SRC was found to be activated in trastuzumab-resistant cells and breast cancer patients who progressed on the drug. By performing a tyrosine phosphoproteome analysis, researchers identified SRC as a mediator of resistance. In preclinical models, combining dasatinib with trastuzumab synergistically increased the antibody's activity, leading to DNA damage, cell cycle arrest, and apoptosis.

Motivated by these findings, GEICAM (Spanish Breast Cancer Group) designed a Phase I-II clinical trial to evaluate the safety and clinical activity of adding dasatinib to trastuzumab and paclitaxel. The Phase I portion focused on determining the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of dasatinib in this combination. Secondary objectives included assessing efficacy, pharmacokinetics, and pharmacodynamics. This article focuses on the safety, pharmacokinetics, and exploratory biomarker analyses from the Phase I part of the study.

  • Study Design: A "3+3" dose-escalation design was used, starting with two oral dose levels of dasatinib: 100mg (DL1) and 140 mg (DL2).
  • Patient Population: Ten patients with HER2-overexpressing advanced breast cancer were enrolled.
  • Recommended Dose: Dasatinib 100 mg daily was established as the recommended RP2D.
  • Treatment Duration: The median number of administered cycles was 12 (range, 1 to 18).
The most common grade 3 treatment-related adverse events at DL1 were diarrhea, hyponatremia, fatigue, and elevated liver enzymes. Importantly, the study observed a significant reduction in phosphorylated SRC (p-SRC) expression in epidermal keratinocytes from sequential skin biopsies. This suggests that dasatinib effectively inhibits its target in combination with trastuzumab and paclitaxel. The Phase II part of the study is currently evaluating efficacy and final results will be reported soon.

Hope for Overcoming Resistance

This Phase I study demonstrates the feasibility of combining dasatinib with trastuzumab and paclitaxel, showing a manageable toxicity profile. This is especially important because the addition of dasatinib did not appear to significantly increase toxicities compared to the standard regimen.

The observed reduction in p-SRC expression confirms the drug's mechanism of action and supports the potential for this combination to overcome trastuzumab resistance. These findings align with preclinical models, suggesting that dasatinib enhances trastuzumab's activity by inhibiting the pAKT and pSRC pathways.

The ongoing Phase II study will further evaluate the efficacy of this combination in patients with HER2-positive breast cancer. If successful, this approach could provide a valuable new treatment option for patients who develop resistance to existing therapies, improving outcomes and quality of life.

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This article is based on research published under:

DOI-LINK: 10.18632/oncotarget.17113, Alternate LINK

Title: A Phase I Study Of The Src Kinase Inhibitor Dasatinib With Trastuzumab And Paclitaxel As First Line Therapy For Patients With Her2-Overexpressing Advanced Breast Cancer. Geicam/2010-04 Study

Subject: Oncology

Journal: Oncotarget

Publisher: Impact Journals, LLC

Authors: Alberto Ocana, Marta Gil-Martin, Miguel Martín, Federico Rojo, Silvia Antolín, Ángel Guerrero, José Manuel Trigo, Montse Muñoz, Atanasio Pandiella, Núria Gonzalo Diego, Susana Bezares, Rosalía Caballero, Eva Carrasco, Ander Urruticoechea

Published: 2017-04-14

Everything You Need To Know

1

Why do some HER2-positive breast cancers become resistant to trastuzumab?

Trastuzumab, a monoclonal antibody, is a cornerstone treatment for HER2-overexpressing breast cancer. However, resistance to trastuzumab is a significant clinical challenge, meaning that tumors eventually stop responding to the drug. This resistance can occur due to various mechanisms, including the activation of alternative signaling pathways or changes in the HER2 receptor itself. Understanding and overcoming these resistance mechanisms is crucial to improving outcomes for patients with HER2-positive breast cancer.

2

What is dasatinib, and how might it help overcome resistance to trastuzumab in HER2-positive breast cancer?

Dasatinib is an SRC kinase inhibitor. Preclinical studies suggest that SRC inhibition can enhance the activity of trastuzumab. SRC was found to be activated in trastuzumab-resistant cells. Combining dasatinib with trastuzumab synergistically increased the antibody's activity, leading to DNA damage, cell cycle arrest, and apoptosis in preclinical models. This suggests that dasatinib may help overcome trastuzumab resistance.

3

How was the Phase I study designed to test the combination of dasatinib, trastuzumab, and paclitaxel?

The Phase I study used a "3+3" dose-escalation design. It started with two oral dose levels of dasatinib: 100mg (DL1) and 140 mg (DL2). Ten patients with HER2-overexpressing advanced breast cancer were enrolled. The primary goal of Phase I was to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of dasatinib in combination with trastuzumab and paclitaxel. The recommended dose was established at Dasatinib 100 mg daily. The median number of administered cycles was 12 (range, 1 to 18).

4

What evidence from the Phase I study suggests that dasatinib is actually working to inhibit its intended target in patients?

The Phase I study observed a significant reduction in phosphorylated SRC (p-SRC) expression in epidermal keratinocytes from sequential skin biopsies. This is important because it suggests that dasatinib effectively inhibits its target (SRC kinase) when combined with trastuzumab and paclitaxel in patients. This pharmacodynamic effect supports the rationale for using dasatinib to overcome trastuzumab resistance.

5

What were the main findings of the Phase I study regarding the safety and tolerability of combining dasatinib with trastuzumab and paclitaxel, and what are the implications?

The Phase I study demonstrated the feasibility of combining dasatinib with trastuzumab and paclitaxel, showing a manageable toxicity profile. Common side effects at the 100mg dose of dasatinib included diarrhea, hyponatremia, fatigue, and elevated liver enzymes. This is significant because the addition of dasatinib did not appear to significantly increase toxicities compared to the standard regimen of trastuzumab and paclitaxel. This suggests that this combination could be a safe and effective treatment option for patients with HER2-positive breast cancer who have developed resistance to trastuzumab. The Phase II portion of the study is designed to further evaluate the efficacy of this treatment combination.

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