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NCT03368729 · ClinicalTrials.gov registry record · Phase 1

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

A Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma, sponsored by University of Alabama at Birmingham.

Active
Registry status
Phase 1
Development phase
46
Enrollment target
7
Study locations

NCT03368729 is a Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 46 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT03368729, a Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
46 participants
Enrollment target
7
Study locations

Study Summary

The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.

Conditions Studied

Metastatic Breast Cancer HER2-Positive Breast Carcinoma

Interventions

  • DRUG Trastuzumab
  • DRUG Niraparib

Study Locations (7)

Alabama

  • University of Alabama at Birmingham - Birmingham

Illinois

  • University of Chicago - Chicago

Minnesota

  • Mayo Clinic - Rochester

New York

  • Montefiore - The Bronx

North Carolina

  • University of North Carolina - Chapel Hill

Pennsylvania

  • University of Pennsylvania - Philadelphia

Washington

  • University of Washington- - Seattle

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2019-09-06
Est. Completion 2027-12-30
Phase Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

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What the Registry Record Tells You About NCT03368729

The ClinicalTrials.gov registry entry for NCT03368729 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (78% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab is the first listed.

NCT03368729 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, Illinois, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03368729 about?

NCT03368729 is a clinical study titled "Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer". The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhi...

What is the current status of trial NCT03368729?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-09-06. Estimated completion is 2027-12-30.

What conditions does trial NCT03368729 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Positive Breast Carcinoma.

What interventions are being tested in trial NCT03368729?

The interventions under investigation include: Trastuzumab (DRUG), Niraparib (DRUG).

Who is sponsoring clinical trial NCT03368729?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03368729 being conducted?

This trial has 7 study locations across Alabama, Illinois, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.