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NCT05035836 · ClinicalTrials.gov registry record · Phase 2

A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)

A Phase 2 study of Breast Cancer and HER2-positive, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT05035836: Recruiting Phase 2 study of Breast Cancer and HER2-positive, sponsored by M.D. Anderson Cancer Center.

NCT05035836 is a Phase 2 study of Breast Cancer and HER2-positive that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05035836, a Phase 2 study of Breast Cancer and HER2-positive, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .

Interventions

  • DRUG Tamoxifen
  • DRUG Letrozole
  • DRUG Zanidatamab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-11-16
Est. Completion 2028-12-29
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What NCT05035836 shows while recruiting

NCT05035836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Tamoxifen is the first listed.

NCT05035836 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05035836 about?

NCT05035836 is a clinical study titled "A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)". This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic comple...

What is the current status of trial NCT05035836?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-11-16. Estimated completion is 2028-12-29.

What conditions does trial NCT05035836 study?

This clinical trial studies the following conditions: Breast Cancer, HER2-positive.

What interventions are being tested in trial NCT05035836?

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

Who is sponsoring clinical trial NCT05035836?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05035836 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

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 NCT05035836's enrollment target sits among peer trials

20 1079th of 1224 higher than 112 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer 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 NCT05035836, the US trial registry maintained by the National Library of Medicine. NCT05035836 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.