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RecruitingPhase 2

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

Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completion of study treatment, patients are followed up at 30 days then at least twice yearly for 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a lower dose of docetaxel with cyclophosphamide, two chemotherapy drugs. It is for women age 65 or older with stage I–III HER2-negative breast cancer who may be more likely to have side effects. The study looks at how well treatment works and whether it improves quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 65 or older when joining the study.
  • Have breast cancer confirmed by a tissue or cell test. It must be HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Have invasive cancer that has grown into nearby breast tissue but has not spread to distant parts of the body.
  • Have known estrogen and progesterone hormone receptor test results. Any result is allowed.
  • Your doctor must recommend docetaxel and cyclophosphamide before or after surgery. If you have more than one breast cancer, all must be HER2-negative, and your doctor must expect treatment to help at least one.
  • Surgery, lymph node checks, radiation, and hormone treatment must not happen during study treatment. Prior hormone treatment is allowed; your doctor may allow immune therapy during the study.
  • You or a legally approved person must be able to give consent for you to join.
  • Be willing to answer surveys. You do not need to speak or read English if suitable interpreters or surveys in your language are available.

Who can't join

  • You have already had chemotherapy for your current breast cancer.
  • Your cancer has come back or spread to distant parts of the body. A past breast cancer is allowed if your doctor believes the current cancer is new.
  • You have had an allergic reaction to drugs similar to docetaxel or cyclophosphamide.
  • You have had docetaxel and cyclophosphamide together for a past breast cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

CA

MA

NY