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NCT00376688

Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Completed Phase 2 Results posted Last updated 24 February 2020
What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Breast Carcinoma in 31 participants. Completed in 16 December 2019.

Timeline
11 July 2006
Primary endpoint
12 June 2008
16 December 2019

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment31
Start date11 July 2006
Primary completion12 June 2008
Estimated completion16 December 2019
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Breast Carcinoma or Stage III Breast Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease) Primary · Up to 24 months

Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks. Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qu

GroupValue95% CI
Treatment (Temsirolimus)9.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Temsirolimus)
Serious: 9/31 (29%)
Deaths:

Serious adverse events (6 terms)

ReactionSystemTreatment (Temsirolimus)
DyspneaRespiratory, thoracic and mediastinal disorders
Death NOSGeneral disorders
Abdominal painGastrointestinal disorders
NauseaGastrointestinal disorders
Platelet count decreasedInvestigations
VomitingGastrointestinal disorders
Other adverse events (12 terms — click to expand)

ReactionSystemTreatment (Temsirolimus)
Lymphocyte count decreasedInvestigations
HypophosphatemiaMetabolism and nutrition disorders
Alanine aminotransferase increasedInvestigations
Alkaline phosphatase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
DyspneaRespiratory, thoracic and mediastinal disorders
FatigueGeneral disorders
HyperglycemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
Neutrophil count decreasedInvestigations
Platelet count decreasedInvestigations
White blood cell decreasedInvestigations

Most-reported serious reactions: Dyspnea, Death NOS, Abdominal pain, Nausea, Platelet count decreased, Vomiting.

Data from ClinicalTrials.gov NCT00376688 adverse events section.

Sponsor's own description

This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

  1. 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
  2. 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
  3. Emerging therapeutic targets in metastatic progression: A focus on breast cancer.
    Li Z, Kang Y. · · 2016 · cited 51× · PMID 27000769 · DOI 10.1016/j.pharmthera.2016.03.003
  4. The Biological Roles and Clinical Applications of the PI3K/AKT Pathway in Targeted Therapy Resistance in HER2-Positive Breast Cancer: A Comprehensive Review.
    Zhong H, Zhou Z, Wang H, Wang R, et al · · 2024 · cited 26× · PMID 39769140 · DOI 10.3390/ijms252413376

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Recurrent Breast Carcinoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00376688.

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