Recruiting
Phase 2

Docetaxel & Cyclophosphamide

Sponsor:

City of Hope Medical Center

Code:

NCT06042569

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

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Docetaxel

Medical Chart Review

Questionnaire Administration

Study Details

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.

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

Study ID

NCT06042569

Start date

Sep 16, 2024

Status verified date

Apr, 2026

Completion date

Mar 20, 2030

Anticipated

Primary completion date

Mar 20, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I: (Dose-reduced docetaxel, cyclophosphamide)

Patients receive dose-reduced docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

active comparator: Arm II: (Standard dose docetaxel, cyclophosphamide)

Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

Cyclophosphamide

Given IV

Docetaxel

Given IV

Medical Chart Review

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Thanh Nga Doan, MD

626-321-1845tdoan@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Thanh Nga Doan

626-256-4673tdoan@coh.org

Principal Investigator:

Thanh Nga Doan

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rachel Freedman, MD

617-632-3000Rachel_Freedman@dfci.harvard.edu

Principal Investigator:

Rachel Freedman, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Allison Magnuson, MD

585-602-5085allison_magnuson@urmc.rochester.edu

Principal Investigator:

Allison Magnuson

More Information

Sponsor

City of Hope Medical Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-04-17.