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NCT02152943
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
Phase 1 trial testing Everolimus in Advanced Malignant Solid Neoplasm in 37 participants. Completed in 14 December 2020.
14 December 2020
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 17 July 2014 |
| Primary completion | 14 December 2020 |
| Estimated completion | 14 December 2020 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Everolimus (everolimus) — full drug profile →
- Laboratory Biomarker Analysis
- Letrozole — full drug profile →
- Trastuzumab (trastuzumab) — full drug profile →
Conditions studied
- Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
- Estrogen Receptor Positive — all drugs for Estrogen Receptor Positive →
- HER2/Neu Positive — all drugs for HER2/Neu Positive →
- Postmenopausal — all drugs for Postmenopausal →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Advanced Malignant Solid Neoplasm or Estrogen Receptor Positive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2 (HER2)-positive breast cancer or other solid tumors that have spread to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells. Immunotherapy with monoclonal antibodies, such as trastuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving everolimus, letrozole, and trastuzumab together may be a better treatment for breast cancer and other solid tumors than everolimus alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanisms of resistance and sensitivity to anti-HER2 therapies in HER2+ breast cancer.
de Melo Gagliato D, Jardim DL, Marchesi MS, Hortobagyi GN. · · 2016 · cited 144× · PMID 26824988 · DOI 10.18632/oncotarget.7043 -
PI3K/AKT/mTOR-Targeted Therapy for Breast Cancer.
Zhu K, Wu Y, He P, Fan Y, et al · · 2022 · cited 117× · PMID 36010585 · DOI 10.3390/cells11162508 -
Investigational chemotherapy and novel pharmacokinetic mechanisms for the treatment of breast cancer brain metastases.
Shah N, Mohammad AS, Saralkar P, Sprowls SA, et al · · 2018 · cited 102× · PMID 29604436 · DOI 10.1016/j.phrs.2018.03.021 -
Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment.
Yu S, Liu Q, Han X, Qin S, et al · · 2017 · cited 82× · PMID 29209558 · DOI 10.1186/s40164-017-0091-4 -
First-line therapy in HER2 positive metastatic breast cancer: is the mosaic fully completed or are we missing additional pieces?
Fabi A, Malaguti P, Vari S, Cognetti F. · · 2016 · cited 32× · PMID 27357210 · DOI 10.1186/s13046-016-0380-5 -
Resistance to therapy in estrogen receptor positive and human epidermal growth factor 2 positive breast cancers: progress with latest therapeutic strategies.
Lousberg L, Collignon J, Jerusalem G. · · 2016 · cited 27× · PMID 27800032 · DOI 10.1177/1758834016665077 -
Phase I Study of Everolimus, Letrozole, and Trastuzumab in Patients with Hormone Receptor-positive Metastatic Breast Cancer or Other Solid Tumors.
Ballhausen A, Wheler JJ, Karp DD, Piha-Paul SA, et al · · 2021 · cited 10× · PMID 33115815 · DOI 10.1158/1078-0432.ccr-20-2878 -
Molecular Biology in the Breast Clinics-Current status and future perspectives.
Parmar V, Nair NS, Thakkar P, Chitkara G. · · 2021 · PMID 33994723 · DOI 10.1007/s13193-019-00954-1
Verify or expand the search:
- PubMed search for NCT02152943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other recruiting trials for Advanced Malignant Solid Neoplasm
Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02152943 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 19 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02152943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing