NCT06042569 Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
| NCT ID | NCT06042569 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | City of Hope Medical Center |
| Condition | Anatomic Stage I Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2030-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 174 participants in total. It began in 2024-09-16 with a primary completion date of 2030-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Thanh Nga E Doan, MD
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT06042569 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Anatomic Stage I Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06042569 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06042569 currently recruiting?
Yes, NCT06042569 is actively recruiting participants. Contact the research team at tdoan@coh.org for enrollment information.
Where is the NCT06042569 trial being conducted?
This trial is being conducted at Duarte, United States, Boston, United States, Rochester, United States.
Who is sponsoring the NCT06042569 clinical trial?
NCT06042569 is sponsored by City of Hope Medical Center. The principal investigator is Thanh Nga E Doan, MD at City of Hope Medical Center. The trial plans to enroll 174 participants.
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