Dose-Reduced Docetaxel with Cyclophosphamide for Breast Cancer
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Recruiting
Phase 2Interventional Study
Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
This trial is looking for women aged 65 and older with early-stage HER2-negative breast cancer. Participants will receive a lower dose of docetaxel combined with cyclophosphamide as treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am 65 years old or older.
I have been diagnosed with breast cancer that is HER2-negative.
I can give my consent or have a representative to consent for me.
I will answer questionnaires as part of the study.
I have non-metastatic invasive breast cancer.
I understand that my treatment journey may include other therapies decided by my doctor.
I have had prior hormonal therapy but can hold it during the study.
I speak or read languages other than English, with interpreter services available.
You may not be able to join if
I have already received chemotherapy for my current breast cancer.
I have recurrent or metastatic breast cancer.
I have a history of allergic reactions to cyclophosphamide or docetaxel.
I have been treated with docetaxel and cyclophosphamide for a previous breast cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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…
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.
Trial Locations
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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 con…
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
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