A phase 2 study of everolimus combined with trastuzumab and paclitaxel in patients with HER2-overexpressing advanced breast cancer that progressed during prior trastuzumab and taxane therapy
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Increased activation of the PI3K/Akt/mTOR pathway is a common factor in putative mechanisms of trastuzumab resistance, resulting in dysregulation of cell migration, growth, proliferation, and survival. Data from preclinical and phase 1/2 clinical studies suggest that adding everolimus (an oral mTOR inhibitor) to trastuzumab plus chemotherapy may enhance the efficacy of, and restore sensitivity to, trastuzumab-based therapy. In this phase 2 multicenter study, adult patients with HER2-positive advanced breast cancer resistant to trastuzumab and pretreated with a taxane received everolimus 10 mg/day in combination with paclitaxel (80 mg/m(2) days 1, 8, and 15 every 4 weeks) and trastuzumab (4 mg/kg loading dose followed by 2 mg/kg weekly), administered in 28-day cycles. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Fifty-five patients were enrolled; one remained on study treatment at the time of data cutoff. The median number of prior chemotherapy lines for advanced disease was 3.5 (range 1-11). The ORR was 21.8 %, the clinical benefit rate was 36.4 %, the median PFS estimate was 5.5 months (95 % confidence interval [CI]: 4.99-7.69 months), and the median OS estimate was 18.1 months (95 % CI: 12.85-24.11 months). Hematologic grade 3/4 adverse events (AEs) included neutropenia (25.5 % grade 3, 3.6 % grade 4), anemia (7.3 % grade 3), and thrombocytopenia (5.5 % grade 3, 1.8 % grade 4). Nonhematologic grade 3/4 AEs included stomatitis (20.0 %), diarrhea (5.5 %), vomiting (5.5 %), fatigue (5.5 %), and pneumonia (5.5 %), all grade 3. These findings suggest that the combination of everolimus plus trastuzumab and paclitaxel is feasible, with promising activity in patients with highly resistant HER2-positive advanced breast cancer. This combination is currently under investigation in the BOLERO-1 phase 3 trial.
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Blockade of mTOR downstream HER2 with the TORC1 inhibitor everolimus, while maintaining trastuzumab therapy, can induce clinical responses in HER2+ cancers that have progressed on trastuzumab.
“More recent data suggest that blockade of mTOR downstream HER2 with the TORC1 inhibitor everolimus, while maintaining trastuzumab therapy, can induce clinical responses in HER2+ cancers that have progressed on trastuzumab (Hurvitz et al., 2013; Morrow et al., 2011; O’Regan, 2013).”
From ERBB Receptors: From Oncogene Discovery to Basic Science to Mechanism-Based Cancer Therapeutics (2014) · cites this paper as Hurvitz et al., 2013
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- Authors
- Hurvitz, S. A., Dalenc, F., Campone, M., O’Regan, R. M., Tjan-Heijnen, V. C., Gligorov, J., Llombart, A., Jhangiani, H., Mirshahidi, H. R., Tan-Chiu, E., Miao, S., El-Hashimy, M., Lincy, J., Taran, T., Soria, J.-C., Sahmoud, T., & André, F.
- Affiliations
- University of California, Los Angeles (US)
- Institut Claudius Regaud (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Compassionate Cancer Care (US)
- Loma Linda University Medical Center (US)
- Florida Cancer Care (US)
- Novartis (Switzerland) (CH)
- Institut Gustave Roussy (FR)
- Corresponding author
- Hurvitz, Sara A.
- ORCID
- Venue
- Breast Cancer Research and Treatment
- Published
- 2013-10
- Volume
- 141
- Issue
- 3
- Pages
- 437-446
- ISSN
- 0167-6806 (ISSN-L)
- 1573-7217
- PMC
- PMC3824346
- OpenAlex
- W2036950786
- Cited by
- 76
- References
- 31
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 5 · 2022: 4 · 2021: 1 · 2020: 7 · 2019: 8 · 2018: 6 · 2017: 8 · 2016: 10 · 2015: 11 · 2014: 10 · 2013: 1
- FWCI
- 5.71
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Breast Cancer Research and Treatment (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by-nc)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › PI3K/AKT/mTOR signaling in cancer
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
- Keywords
- everolimus, trastuzumab, paclitaxel, HER2-positive breast cancer, advanced breast cancer, trastuzumab resistance, mTOR inhibition, PI3K/AKT/mTOR pathway, combination chemotherapy, progression-free survival, overall survival, neutropenia, adverse events, drug safety and tolerability, clinical benefit rate, overall response rate
- MeSH terms
- Everolimus, Trastuzumab, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Middle Aged, Neoplasm Staging, Treatment Failure, Paclitaxel, Disease Progression, Disease-Free Survival, Erb-b2 Receptor Tyrosine Kinases, Sirolimus, Taxoids, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized
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