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NCT03499353 · ClinicalTrials.gov registry record · Phase 2

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

A Phase 2 study, sponsored by Pfizer.

Terminated
Registry status
Phase 2
Development phase
61
Enrollment target

NCT03499353: Clinical Trial Phase 2 study, sponsored by Pfizer.

NCT03499353 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03499353, a Phase 2 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

Primary Outcome

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by sur

Interventions

  • DRUG TALAZOPARIB

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2018-08-27
Est. Completion 2020-09-23
Phase Phase 2
Pfizer

1,845 total trials

Why NCT03499353 stopped before completion

NCT03499353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

The record links to 0 conditions, and to 1 intervention - of which TALAZOPARIB is the first listed.

NCT03499353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03499353 about?

NCT03499353 is a clinical study titled "Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer". A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

What is the current status of trial NCT03499353?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2018-08-27. Estimated completion is 2020-09-23.

What interventions are being tested in trial NCT03499353?

The interventions under investigation include: TALAZOPARIB (DRUG).

Who is sponsoring clinical trial NCT03499353?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03499353's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 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 NCT03499353, the US trial registry maintained by the National Library of Medicine. NCT03499353 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.