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NCT06434064 · ClinicalTrials.gov registry record · Phase 2

Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer

A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT06434064: Recruiting Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.

NCT06434064 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 30 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (90% 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

NCT06434064, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.

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

Study Summary

This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.

Primary Outcome

Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized using frequencies and relative frequencies.

Conditions Studied

Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Triple-Negative Breast Carcinoma Locally Advanced Unresectable Triple-Negative Breast Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Echocardiography

Study Locations (1)

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-03-15
Est. Completion 2028-11-30
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What NCT06434064 shows while recruiting

NCT06434064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (90% lower).

The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06434064 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT06434064 about?

NCT06434064 is a clinical study titled "Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer". This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (local...

What is the current status of trial NCT06434064?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-03-15. Estimated completion is 2028-11-30.

What conditions does trial NCT06434064 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Locally Advanced Unresectable Triple-Negative Breast Carcinoma.

What interventions are being tested in trial NCT06434064?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography (PROCEDURE).

Who is sponsoring clinical trial NCT06434064?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06434064 being conducted?

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

Learn More About Clinical Trials

Similar trials for Anatomic Stage III Breast Cancer AJCC v8

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 NCT06434064's enrollment target sits among peer trials

30 64th of 84 higher than 17 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 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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More recruiting context for NCT06434064

Source: ClinicalTrials.gov NCT06434064, the US trial registry maintained by the National Library of Medicine. NCT06434064 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.