Study on Lower Dose Docetaxel and Cyclophosphamide for Older Women with Early Stage HER2 Negative Breast Cancer (DOROTHY Trial)

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06042569

Provider View

This clinical trial is exploring whether a lower dose of the chemotherapy drugs docetaxel and cyclophosphamide can effectively treat older women with early stage HER2 negative breast cancer, while reducing side effects and improving quality of life.

Patient Parameters

Program Overview

The DOROTHY trial is testing if a reduced dose of the chemotherapy drugs docetaxel and cyclophosphamide can work well for older women with early stage HER2 negative breast cancer. These drugs help stop cancer cells from growing and spreading. However, the standard dose can be hard for older patients to handle. This study aims to see if a lower dose can be just as effective and easier on patients, improving their quality of life.

Description

PRIMARY OBJECTIVE:

  • To compare how well patients tolerate a lower dose of docetaxel compared to the standard dose.

SECONDARY OBJECTIVE:

  • To compare how patients handle the lower dose versus the standard dose of docetaxel.

STUDY DESIGN:

Participants are randomly assigned to one of two groups:

  • Group 1: Receives a lower dose of docetaxel and cyclophosphamide through an IV on the first day of each treatment cycle. Each cycle lasts 21 days, and treatment is repeated for 4 cycles unless the cancer progresses or side effects become too severe.

  • Group 2: Receives the standard dose of docetaxel and cyclophosphamide through an IV on the first day of each treatment cycle. Each cycle lasts 21 days, and treatment is repeated for 4 cycles unless the cancer progresses or side effects become too severe.

After finishing the treatment, participants will have follow-up visits 30 days later and then at least twice a year for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent or have a representative consent on their behalf.
  • Willing to complete questionnaires during the study.
  • Aged 65 years or older.
  • Have a Cancer and Aging Research Group-Breast Cancer (CARG-BC) score of 6 or higher.
  • Diagnosed with HER2 negative breast cancer based on recent guidelines.
  • Estrogen and progesterone receptor status must be known; any status is eligible.
  • Have non-metastatic, invasive breast cancer.
  • Recommended to receive standard or reduced dose chemotherapy with docetaxel and cyclophosphamide by their doctor.
  • May be receiving immunotherapy at the same time, as decided by their doctor.
  • Any surgery, radiation, or hormonal therapy should not occur at the same time as the study treatment.
  • Patients with multiple breast cancers must have all cancers be HER2 negative and benefit from the treatment.
  • Non-English speakers are eligible if interpreter services or translated surveys are available.

Exclusion Criteria

  • Have already received chemotherapy for their current breast cancer.
  • Have recurrent or metastatic breast cancer.
  • Have a history of allergic reactions to similar drugs as cyclophosphamide or docetaxel.
  • Have been treated with the same chemotherapy regimen for a previous breast cancer.

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