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NCT06042569 · ClinicalTrials.gov registry record · Phase 2

Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial

A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 2
Development phase
174
Enrollment target
2
Study locations

NCT06042569: Recruiting Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.

NCT06042569 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 174 participants, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06042569, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 2
Development phase
174 participants
Enrollment target
2
Study locations

Study Summary

This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.

Primary Outcome

RDI is defined as the ratio of actual dose intensity received to the standard dose intensity, ranging from 0 to 100%. The RDI between the two arms will be compared using T-test, RDI difference and 90% confidence interval. A one-sided p-value \< 0.05 will be considered statistically significant.

Conditions Studied

Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Docetaxel
  • OTHER Questionnaire Administration
  • OTHER Medical Chart Review

Study Locations (2)

California

  • City of Hope Medical Center - Duarte

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2024-09-16
Est. Completion 2030-03-20
Phase Phase 2
City of Hope Medical Center

582 total trials

What NCT06042569 shows while recruiting

NCT06042569 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (43% lower).

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

NCT06042569 reports a single indexed study location in California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06042569 about?

NCT06042569 is a clinical study titled "Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial". This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the gro...

What is the current status of trial NCT06042569?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2024-09-16. Estimated completion is 2030-03-20.

What conditions does trial NCT06042569 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma.

What interventions are being tested in trial NCT06042569?

The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Questionnaire Administration (OTHER), Medical Chart Review (OTHER).

Who is sponsoring clinical trial NCT06042569?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06042569 being conducted?

This trial has 2 study locations across California, Massachusetts. 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 NCT06042569's enrollment target sits among peer trials

174 26th of 84 higher than 59 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 NCT06042569

Source: ClinicalTrials.gov NCT06042569, the US trial registry maintained by the National Library of Medicine. NCT06042569 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.