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

Last updated: January 28, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Medical Chart Review

Questionnaire Administration

Docetaxel

Clinical Study ID

NCT06042569
21374
21374
NCI-2023-06506
P30CA033572
  • Ages > 65
  • All Genders

Study 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

Inclusion Criteria:

  • Ability to provided informed consent or a legally authorized representative is ableto 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 epidermalgrowth factor receptor 2 negative (HER2-negative) per the most recent 2018 AmericanSociety of Clinical Oncology College of American Pathologists (ASCO CAP) guidelinesrelapsed/ refractory disease

  • Estrogen receptor and progesterone receptor immunohistochemistry (IHC) status mustbe known; any estrogen receptor (ER)/progesterone receptor (PR) status is eligible

  • Non-metastatic, invasive breast cancer (scans are not required to documentnon-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 thediscretion of the treating physician

  • Any surgery, nodal assessment, radiation, hormonal therapy is left up to thetreating provider but should not occur concurrently with study therapy

  • Any patient who received pre-operative hormonal therapy and who is then recommendedfor neo/adjuvant chemotherapy is eligible, though hormonal therapy should be heldduring study treatment administration

  • For patients with bilateral or multifocal/multicentric breast cancers, the followingcriteria must be met to enroll: (1) both cancer are HER2 negative, AND (2) theprovider 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 adequateinterpreter services are available or the surveys are available in the preferredlanguage (i.e. the Geriatric Assessment [GA] and Patient Reported Outcomes [PRO]surveys are available in many languages)

Exclusion

Exclusion Criteria:

  • Participants who have already received any chemotherapy for their current breastcancer

  • Patients with recurrent and/or metastatic disease will be excluded. Prior diagnosesof breast cancers (including ductal carcinoma in situ [DCIS]) are allowed, providedthat the treating provider feels that the current cancer most likely represents anew primary breast cancer and not recurrent disease

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to cyclophosphamide and/or docetaxel

  • Past treatment with the regimen TC for prior breast cancer

Study Design

Total Participants: 174
Treatment Group(s): 4
Primary Treatment: Medical Chart Review
Phase: 2
Study Start date:
September 16, 2024
Estimated Completion Date:
March 20, 2028

Study Description

PRIMARY OBJECTIVE:

I. Compare the relative dose intensity (RDI) of reduced- versus (vs.) standard-dose docetaxel dosing strategies.

SECONDARY OBJECTIVE:

I. Compare treatment tolerability of reduced- vs. standard-dose docetaxel dosing strategies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dose-reduced docetaxel intravenously (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.

ARM II: 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.

After completion of study treatment, patients are followed up at 30 days then at least twice yearly for 2 years.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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