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Alkylating agents

Reduced-Dose Chemotherapy for Breast Cancer

Phase 2

Recruiting

Led By Thanh Nga E Doan, MD

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

Must not have

Past treatment with the regimen TC for prior breast cancer

Participants who have already received any chemotherapy for their current breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with TC for breast cancer before.

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I have received chemotherapy for my current breast cancer.

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My cancer has returned or spread to other parts of my body.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative dose intensity (RDI)

Secondary study objectives

Changes in function and health status

Differences in PRO-CTCAE and clinician-reported toxicities

Distant recurrences

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Docetaxel

1995

Completed Phase 4

~6550