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NCT05914792

Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery

Active, enrolled Last updated 10 April 2025
What this trial tests

trial in Breast Cancer in 49 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
19 April 2022
Primary endpoint
16 October 2024
1 July 2026

Quick facts

Lead sponsorUniversity of Pittsburgh
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment49
Start date19 April 2022
Primary completion16 October 2024
Estimated completion1 July 2026
Sites1 location across United States

Conditions studied

Sponsor

University of Pittsburgh

Who can join

70 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Omission of surgery, primary endocrine therapy adherence, and effect of comorbidity in older women with estrogen receptor positive breast cancer.
    Carleton N, Abidi H, Puthanmadhom-Narayanan S, Marroquin OC, et al · · 2024 · cited 5× · PMID 38135542 · DOI 10.1016/j.jgo.2023.101679
  2. Use of ctDNA in Older Women with ER+ Breast Cancer to Facilitate Surgical De-escalation: A Prospective, Hybrid-Decentralized Trial with Correlative Studies.
    Carleton N, Chang AC, Chen F, Puhalla SL, et al · · 2026 · PMID 41854411 · DOI 10.1158/1078-0432.ccr-25-4079
  3. Longitudinal ctDNA Surveillance in Older Women with ER+ Breast Cancer to Facilitate Surgical De-Escalation: A Prospective, Hybrid-Decentralized Trial with Correlative Studies
    Carleton N, Chang AC, Chen F, Puhalla SL, et al · · 2025 · DOI 10.1101/2025.08.23.25332468

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other University of Pittsburgh trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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