Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02152943 · ClinicalTrials.gov registry record · Phase 1
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
A Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 5
- Study locations
NCT02152943: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT02152943 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152943, a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Defined as the highest dose at which no more than 1 of 6 patients has had dose-limiting toxicity.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Letrozole
- DRUG Everolimus
- BIOLOGICAL Trastuzumab
Study Locations (5)
Texas
- M D Anderson Cancer Center - Houston
- MD Anderson in Katy - Houston
- MD Anderson League City - Nassau Bay
- MD Anderson in Sugar Land - Sugar Land
- MD Anderson in The Woodlands - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-07-17 |
| Est. Completion | 2020-12-14 |
| Phase | Phase 1 |
What the finished NCT02152943 record still lists
NCT02152943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (79% lower).
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02152943 lists 5 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT02152943 about?
NCT02152943 is a clinical study titled "Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients". 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 ot...
What is the current status of trial NCT02152943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2014-07-17. Estimated completion is 2020-12-14.
What conditions does trial NCT02152943 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Recurrent Breast Carcinoma, Estrogen Receptor Positive, Postmenopausal, Stage IIIA Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02152943?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Letrozole (DRUG), Everolimus (DRUG), Trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02152943?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02152943 being conducted?
This trial has 5 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02152943's enrollment target sits among peer trials
37 68th of 108 higher than 41 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
RECRUITING · Phase 1
-
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
RECRUITING · Phase 1
-
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
RECRUITING · Phase 1
-
Studying TAK-243 in Patients With Advanced Cancer
RECRUITING · Phase 1
-
Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02800486 · 37 participants · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
- NCT03173937 · 37 participants · Phase 1
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
- NCT03295227 · 37 participants · Phase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
- NCT03401047 · 37 participants · Early Phase 1
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI