About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Docetaxel
  • Medical Chart Review
  • Questionnaire Administration

Treatment groups

174 Participants
are divided into 2 treatment groups

Locations

3
City of Hope Medical Center91010, DuarteCalifornia, United States
Dana-Farber Cancer Institute02215, BostonMassachusetts, United States
University of Rochester14642, RochesterNew York, United States

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Rising Tide Foundation

Collaborator