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Alkylating agents

Reduced-Dose Chemotherapy for Breast Cancer

Phase 2

Recruiting

Led By Joanne E Mortimer

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed HER2-negative breast cancer per the most recent 2018 ASCO CAP guidelines relapsed/ refractory disease

Age: >= 65 years by the time of study registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests if a reduced dose of chemo drugs can help older women with early stage breast cancer.

Who is the study for?

This trial is for older women (65+) with early-stage HER2 negative breast cancer who are vulnerable to chemotherapy toxicity. They must have a CARG-BC score of 6 or higher, be able to consent, and willing to answer questionnaires. Excluded are those who've had chemo for their current breast cancer, have recurrent/metastatic disease, or allergies to similar drugs.Check my eligibility

What is being tested?

The DOROTHY trial is testing a reduced dose of docetaxel combined with cyclophosphamide in treating older women with stage I-III HER2 negative breast cancer. The aim is to see if this lower dose can effectively treat the cancer while improving quality of life by reducing side effects.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion such as fever and chills, fatigue, nausea and vomiting, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, mouth sores, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is confirmed HER2-negative and has come back or didn't respond to treatment.

Select...

I am 65 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relative dose intensity (RDI)

Secondary outcome measures

Changes in function and health status

Differences in PRO-CTCAE and clinician-reported toxicities

Distant recurrences

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I: (Dose-reduced docetaxel, cyclophosphamide)Experimental Treatment4 Interventions

Patients receive dose-reduced docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II: (Standard dose docetaxel, cyclophosphamide)Active Control4 Interventions

Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Docetaxel

1995

Completed Phase 4

~5620

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,486 Total Patients Enrolled

43 Trials studying Breast Cancer

6,649 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,267 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Joanne E MortimerPrincipal InvestigatorCity of Hope Medical Center

2 Previous Clinical Trials

170 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on enrollment for this experiment?

"Affirmative. According to records found on clinicaltrials.gov, this scientific investigation opened its recruitment window for participants on October 14th 2023 and is still recruiting up until the present day (September 20th 2023). The research team needs 174 volunteers from 1 dedicated medical facility."

Answered by AI

Is there still an opportunity to participate in this research endeavor?

"That is correct. According to the clinicaltrials.gov database, this analysis was initially published on October 14th 2023 and will require 174 participants from 1 site for completion."

Answered by AI

How efficacious is Arm I: (Dose-reduced docetaxel, cyclophosphamide) in terms of patient safety?

"Our team at Power assigned Arm I: (Dose-reduced docetaxel, cyclophosphamide) a safety rating of 2 since it is currently in phase 2. This implies that there are preliminary results suggesting its security, though no efficacy data has been documented yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042569.