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Dose-Reduced Docetaxel with Cyclophosphamide for Older Women with Early Breast Cancer

This study, called DOROTHY, is testing a new way to give chemotherapy to older women (age 65 and up) with early-stage (Stage I-III) HER2-negative breast cancer. It compares a lower dose of docetaxel with cyclophosphamide to the standard dose of these drugs. Both docetaxel and cyclophosphamide are chemotherapy drugs that work to stop cancer cell growth. The goal is to see if the lower dose is just as effective while being easier to tolerate and improving quality of life for patients who might be more sensitive to side effects. To join, you must be a woman aged 65 or older with HER2-negative breast cancer and be able to provide informed consent. The study aims to enroll 174 participants and is currently unclear on its recruitment status.

Study design
This study is an interventional trial that randomly assigns participants to one of two groups: one receiving a reduced dose of docetaxel with cyclophosphamide, and the other receiving the standard dose. It plans to enroll 174 participants.
What's involved
Participants will receive docetaxel and cyclophosphamide intravenously every 21 days for 4 cycles. They will also complete questionnaires and have medical chart reviews.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will be followed up at 30 days, and then at least twice a year for two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06042569

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

Recruiting
PHASE2Ages 65+InterventionalTreatment
City of Hope Medical Center
~174 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:CyclophosphamideDocetaxelMedical Chart ReviewQuestionnaire Administration

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative dose intensity (RDI)
Measured over At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks)

Conditions

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

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Breast Carcinoma

Where it's being run

3 sites across 3 states
California1
Massachusetts1
New York1

Study leadership

  • Thanh Nga E Doan, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Thanh Nga Doan, MD
[email protected]
626-321-1845
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability to provided informed consent or a legally authorized representative is able to consent on behalf of the patient
Willing to answer questionnaires as part of their participation
Age: \>= 65 years by the time of study registration
Histologically or cytologically confirmed breast cancer(s) that is human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent 2018 American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines relapsed/ refractory disease
Estrogen receptor and progesterone receptor immunohistochemistry (IHC) status must be known; any estrogen receptor (ER)/progesterone receptor (PR) status is eligible
Non-metastatic, invasive breast cancer (scans are not required to document non-metastatic disease- any staging work-up is up to the treating providers' discretion)
Recommended to have either standard dose neoadjuvant docetaxel, cyclophosphamide (TC) chemotherapy or adjuvant TC chemotherapy per their treating provider. Participant may be on immunotherapy concurrently with the protocol regimen at the discretion of the treating physician
Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating provider but should not occur concurrently with study therapy
Any patient who received pre-operative hormonal therapy and who is then recommended for neo/adjuvant chemotherapy is eligible, though hormonal therapy should be held during study treatment administration
For patients with bilateral or multifocal/multicentric breast cancers, the following criteria must be met to enroll: (1) both cancer are HER2 negative, AND (2) the provider feels the patient will benefit from TC for at least one of the cancers
Patients who do not speak or read English are eligible as long as adequate interpreter services are available or the surveys are available in the preferred language (i.e. the Geriatric Assessment \[GA\] and Patient Reported Outcomes \[PRO\] surveys are available in many languages)

Exclusion

Participants who have already received any chemotherapy for their current breast cancer
Patients with recurrent and/or metastatic disease will be excluded. Prior diagnoses of breast cancers (including ductal carcinoma in situ \[DCIS\]) are allowed, provided that the treating provider feels that the current cancer most likely represents a new primary breast cancer and not recurrent disease
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and/or docetaxel
Past treatment with the regimen TC for prior breast cancer

What this trial measures

  • Relative dose intensity (RDI)At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks)

    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.