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NCT04251533 · ClinicalTrials.gov registry record · Phase 3

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

A Phase 3 study of Triple Negative Breast Neoplasms, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
137
Enrollment target
20
Study locations

NCT04251533 is a Phase 3 study of Triple Negative Breast Neoplasms that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 137 participants, below the 649-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT04251533, a Phase 3 study of Triple Negative Breast Neoplasms, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
137 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Conditions Studied

Triple Negative Breast Neoplasms

Interventions

  • DRUG placebo
  • DRUG nab-paclitaxel
  • DRUG alpelisib

Study Locations (20)

Other

  • Novartis Investigative Site - CABA
  • Novartis Investigative Site - Leoben
  • Novartis Investigative Site - Plovdiv

São Paulo

  • Novartis Investigative Site - Barretos
  • Novartis Investigative Site - São Paulo
  • Novartis Investigative Site - São Paulo

Minnesota

  • Mayo Clinic Rochester - Rochester
  • Park Nicollet Institute - Saint Louis Park

California

  • University of California LA - Los Angeles

Louisiana

  • Hematology and Oncology Clinic - Baton Rouge

Tennessee

  • SCRI Oncology Partners - Nashville

Santa Fe Province

  • Novartis Investigative Site - Rosario

Victoria

  • Novartis Investigative Site - Melbourne

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2020-06-08
Est. Completion 2027-01-28
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04251533

The ClinicalTrials.gov registry entry for NCT04251533 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 649-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (79% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Triple Negative Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.

NCT04251533 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, São Paulo, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04251533 about?

NCT04251533 is a clinical study titled "Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss". The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss withou...

What is the current status of trial NCT04251533?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2020-06-08. Estimated completion is 2027-01-28.

What conditions does trial NCT04251533 study?

This clinical trial studies the following conditions: Triple Negative Breast Neoplasms.

What interventions are being tested in trial NCT04251533?

The interventions under investigation include: placebo (DRUG), nab-paclitaxel (DRUG), alpelisib (DRUG).

Who is sponsoring clinical trial NCT04251533?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04251533 being conducted?

This trial has 20 study locations across California, Louisiana, Minnesota, Tennessee, Santa Fe Province. 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.