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NCT02115048 · ClinicalTrials.gov registry record · Phase 2

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

A Phase 2 study, sponsored by Translational Research in Oncology.

Terminated
Registry status
Phase 2
Development phase
44
Enrollment target

NCT02115048: Clinical Trial Phase 2 study, sponsored by Translational Research in Oncology.

NCT02115048 is a Phase 2 study that was terminated before completion, run by Translational Research in Oncology. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02115048, a Phase 2 study, was terminated before completion, sponsored by Translational Research in Oncology.

TERMINATED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study Summary

The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.

Primary Outcome

Progression Free Survival (PFS) is defined as the time from randomization until date of progression (assessed by Response Evaluation Criteria in Solid Tumors - RECIST) or death due to any cause, whichever occurs first. For evaluation of PFS, the randomization date for each patient was the "start date". If the status at the last assessment date was "Non-complete response/ Non-progressive disease" or "Complete response", then the patient was considered "censored". If the status at the last assessm

Interventions

  • DRUG Letrozole
  • DRUG Afatinib

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2014-07
Est. Completion 2018-11
Phase Phase 2

Why NCT02115048 stopped before completion

NCT02115048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.

NCT02115048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02115048 about?

NCT02115048 is a clinical study titled "Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone". The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.

What is the current status of trial NCT02115048?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2014-07. Estimated completion is 2018-11.

What interventions are being tested in trial NCT02115048?

The interventions under investigation include: Letrozole (DRUG), Afatinib (DRUG).

Who is sponsoring clinical trial NCT02115048?

This trial is sponsored by Translational Research in Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02115048's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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

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Source: ClinicalTrials.gov NCT02115048, the US trial registry maintained by the National Library of Medicine. NCT02115048 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.