Who is sponsoring NCT01783756?

NCT01783756 is sponsored by Jonsson Comprehensive Cancer Center.

What drugs are being tested in NCT01783756?

Interventions in NCT01783756: lapatinib ditosylate, everolimus, capecitabine, laboratory biomarker analysis.

What condition does NCT01783756 study?

NCT01783756 studies Central Nervous System Metastases, HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer.

Is NCT01783756 still recruiting?

NCT01783756 is currently completed. Last updated 12 November 2019.

Last reviewed 2019-11-12 · How we verify

NCT01783756

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis

Completed Phase 1, PHASE2 Last updated 12 November 2019

What this trial tests

Phase 1, PHASE2 trial testing lapatinib ditosylate in Central Nervous System Metastases in 9 participants. Completed in 10 May 2019.

Timeline

26 June 2013

Primary endpoint
10 May 2019

10 May 2019

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	26 June 2013
Primary completion	10 May 2019
Estimated completion	10 May 2019
Sites	1 location across United States

Drugs / interventions tested

lapatinib ditosylate — full drug profile →
everolimus (everolimus) — full drug profile →
capecitabine (capecitabine) — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

Central Nervous System Metastases — all drugs for Central Nervous System Metastases →
HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Male Breast Cancer — all drugs for Male Breast Cancer →
Recurrent Breast Cancer — all drugs for Recurrent Breast Cancer →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Central Nervous System Metastases or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have progressed on trastuzumab. The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has proven benefits in metastatic breast cancer may lead to improved clinical outcomes for participants with CNS metastasis. Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate response to the treatment, regular laboratory tests and echocardiogram or Multi Gated Acquisition Scan (MUGA) to assess cardiac activity

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Deregulation of the EGFR/PI3K/PTEN/Akt/mTORC1 pathway in breast cancer: possibilities for therapeutic intervention.
Davis NM, Sokolosky M, Stadelman K, Abrams SL, et al · · 2014 · cited 186× · PMID 25051360 · DOI 10.18632/oncotarget.2209
Breast cancer brain metastases: the last frontier.
Leone JP, Leone BA. · · 2015 · cited 123× · PMID 26605131 · DOI 10.1186/s40164-015-0028-8
Breast cancer brain metastasis: insight into molecular mechanisms and therapeutic strategies.
Wang Y, Ye F, Liang Y, Yang Q. · · 2021 · cited 99× · PMID 34226684 · DOI 10.1038/s41416-021-01424-8
Understanding patterns of brain metastasis in breast cancer and designing rational therapeutic strategies.
Brosnan EM, Anders CK. · · 2018 · cited 98× · PMID 29911111 · DOI 10.21037/atm.2018.04.35
The therapeutic potential of mTOR inhibitors in breast cancer.
Steelman LS, Martelli AM, Cocco L, Libra M, et al · · 2016 · cited 88× · PMID 27059645 · DOI 10.1111/bcp.12958
Breast cancer brain metastasis: molecular mechanisms and directions for treatment.
Pedrosa RMSM, Mustafa DA, Soffietti R, Kros JM. · · 2018 · cited 86× · PMID 29566179 · DOI 10.1093/neuonc/noy044
HER2-positive advanced breast cancer: optimizing patient outcomes and opportunities for drug development.
Singh JC, Jhaveri K, Esteva FJ. · · 2014 · cited 81× · PMID 25025958 · DOI 10.1038/bjc.2014.388
The Dual PI3K/mTOR Pathway Inhibitor GDC-0084 Achieves Antitumor Activity in <i>PIK3CA</i>-Mutant Breast Cancer Brain Metastases.
Ippen FM, Alvarez-Breckenridge CA, Kuter BM, Fink AL, et al · · 2019 · cited 66× · PMID 30796030 · DOI 10.1158/1078-0432.ccr-18-3049

Verify or expand the search:

Other trials of lapatinib ditosylate

Trials testing the same drug.

NCT01873833 — Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic · Phase 2 · terminated
NCT01382706 — Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder · Phase 2 · terminated
NCT00667251 — Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer · Phase 3 · completed
NCT00331630 — Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer · EARLY_PHASE1 · completed
NCT00107003 — GW572016 to Treat Recurrent Malignant Brain Tumors · Phase 2 · completed

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01783756 (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 Jonsson Comprehensive Cancer Center
Last refreshed: 12 November 2019

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/NCT01783756.

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