NCT01111825 is a Phase 1/Phase 2 clinical trial of Temsirolimus in Breast Cancer, sponsored by Puma Biotechnology, Inc..

Who is sponsoring NCT01111825?

NCT01111825 is sponsored by Puma Biotechnology, Inc..

What drugs are being tested in NCT01111825?

Interventions in NCT01111825: Temsirolimus, Neratinib.

What condition does NCT01111825 study?

NCT01111825 studies Breast Cancer.

Is NCT01111825 still recruiting?

NCT01111825 is currently completed. Last updated 29 August 2018.

Are results published for NCT01111825?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-08-29 · How we verify

NCT01111825

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

A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Completed Phase 1/Phase 2 Results posted Last updated 29 August 2018

What this trial tests

Phase 1/Phase 2 trial testing Temsirolimus in Breast Cancer in 99 participants. Completed in 1 July 2016.

Timeline

1 April 2010

Primary endpoint
1 July 2016

1 July 2016

Quick facts

Lead sponsor	Puma Biotechnology, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	99
Start date	1 April 2010
Primary completion	1 July 2016
Estimated completion	1 July 2016
Sites	12 locations across United States, Denmark, France, Hong Kong, Spain, United Kingdom

Drugs / interventions tested

Temsirolimus (temsirolimus) — full drug profile →
Neratinib — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Puma Biotechnology, Inc. — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Objective Response Rate (ORR) (Phase II)
Time frame: From enrollment date to first documented response, or last tumor assessment, assessed up to two years
ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A complete or partial respo

Sponsor's own description

This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.

Publications & conference data

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

The PI3K/AKT/mTOR pathway in breast cancer: targets, trials and biomarkers.
Paplomata E, O'Regan R. · · 2014 · cited 425× · PMID 25057302 · DOI 10.1177/1758834014530023
The fate of chemoresistance in triple negative breast cancer (TNBC).
O'Reilly EA, Gubbins L, Sharma S, Tully R, et al · · 2015 · cited 270× · PMID 26676166 · DOI 10.1016/j.bbacli.2015.03.003
Therapeutic targeting of autophagy in disease: biology and pharmacology.
Cheng Y, Ren X, Hait WN, Yang JM. · · 2013 · cited 188× · PMID 23943849 · DOI 10.1124/pr.112.007120
Therapeutic targets of triple-negative breast cancer: a review.
Jamdade VS, Sethi N, Mundhe NA, Kumar P, et al · · 2015 · cited 143× · PMID 26040571 · DOI 10.1111/bph.13211
Efficacy and mechanism of action of the tyrosine kinase inhibitors gefitinib, lapatinib and neratinib in the treatment of HER2-positive breast cancer: preclinical and clinical evidence.
Segovia-Mendoza M, González-González ME, Barrera D, Díaz L, et al · · 2015 · cited 107× · PMID 26609467
Multidrug-resistant breast cancer: current perspectives.
Martin HL, Smith L, Tomlinson DC. · · 2014 · cited 84× · PMID 24648765 · DOI 10.2147/bctt.s37638
Therapies for triple negative breast cancer.
Andreopoulou E, Schweber SJ, Sparano JA, McDaid HM. · · 2015 · cited 77× · PMID 25881743 · DOI 10.1517/14656566.2015.1032246
Defining biomarkers to predict sensitivity to PI3K/Akt/mTOR pathway inhibitors in breast cancer.
Gonzalez-Angulo AM, Blumenschein GR. · · 2013 · cited 74× · PMID 23218708 · DOI 10.1016/j.ctrv.2012.11.002

Verify or expand the search:

Other trials of Temsirolimus

Trials testing the same drug.

NCT04433572 — Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee · Phase 3 · recruiting
NCT04199026 — Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sa · NA · recruiting
NCT03203525 — Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurre · Phase 1 · active not recruiting
NCT03942601 — Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropop · Phase 2 · terminated
NCT03158389 — NCT Neuro Master Match - N²M² (NOA-20) · Phase 1, PHASE2 · completed

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Puma Biotechnology, Inc. trials

Trials by the same sponsor.

NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) · Phase 2 · not yet recruiting
NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta · Phase 2 · recruiting
NCT06095505 — A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer · Phase 2 · recruiting
NCT04366713 — A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib · Phase 2 · completed
NCT03786107 — HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research St · terminated

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 NCT01111825 (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 Puma Biotechnology, Inc.
Last refreshed: 29 August 2018

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/NCT01111825.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing