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Study on Chemotherapy and Hormone Therapy for Women Over 70 with ER-Positive, HER2-Negative Breast Cancer Using Cyclophosphamide and Drug Combination

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for estrogen receptor (ER)-positive HER2-negative breast cancer in women over the age of 70. The study is exploring the effects of combining chemotherapy with hormone therapy compared to hormone therapy alone. The chemotherapy drugs being used in this study include cyclophosphamide, doxorubicin, and docetaxel. These medications are administered through an intravenous (IV) route, which means they are given directly into a vein.

The purpose of the study is to evaluate the benefit of adding chemotherapy to the treatment plan for elderly patients who have a high risk of cancer returning, as determined by a specific test called the Genomic Grade (GG). Participants in the study will receive treatment over a period of up to 12 months. The study will follow participants for four years to assess their overall survival, which means the length of time they live after starting the treatment. Other aspects being evaluated include the quality of life and any side effects experienced during the treatment.

This trial is part of a larger effort by the French UNICANCER Geriatric Oncology Group and Breast Group to improve treatment options for older women with this type of breast cancer. The study aims to provide valuable information on how effective the combination of chemotherapy and hormone therapy is in improving survival rates and quality of life for these patients. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

    A written informed consent form is signed, agreeing to the use of medical data and participation in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate overall health, including blood tests and imaging if necessary.

    This assessment ensures that all health parameters meet the study requirements.

  3. Step 3

    Treatment phase

    The treatment involves the administration of chemotherapy drugs: cyclophosphamide, doxorubicin, and docetaxel. These are given through an intravenous infusion.

    The dosage and frequency of these medications are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Endocrine treatment

    In addition to chemotherapy, endocrine treatment is provided to target hormone receptors in the cancer cells.

    This treatment is tailored based on individual health needs and the specific characteristics of the cancer.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor health status and response to treatment.

    These appointments include physical exams, blood tests, and possibly imaging studies to assess the effectiveness of the treatment.

  6. Step 6

    Quality of life assessment

    Quality of life is evaluated using specific questionnaires designed for elderly patients with cancer.

    This assessment helps to understand the impact of treatment on daily life and overall well-being.

  7. Step 7

    Completion of study

    The study concludes after a follow-up period of four years, during which overall survival and other health outcomes are evaluated.

    Final assessments are conducted to gather data on the long-term effects of the treatment.

Who can join the trial?

14 criteria

  • Women aged 70 years or older.
  • Kidney function must be adequate, with a creatinine clearance of at least 40 mL/min. This is a measure of how well the kidneys are working.
  • Performance status (PS) should be 2 or less. This is a scale that measures how well a patient can perform ordinary tasks.
  • The patient must be able to follow the study protocol.
  • The patient must have signed a written informed consent form before any study-specific procedures. This includes agreeing to use stored tumor material for genetic testing and data collection.
  • The patient must have health insurance.
  • The patient must have a confirmed diagnosis of invasive breast cancer, regardless of the type.
  • Complete surgery must have been performed before joining the study. This could be a radical modified mastectomy or breast-conserving surgery, with either a sentinel lymph node procedure or axillary lymph node dissection.
  • Any lymph node status is acceptable, whether cancer is present in the lymph nodes (pN+) or not (pN0).
  • No visible signs of cancer spread to other parts of the body (metastases).
  • The cancer must be **oestrogen receptor (ER)-positive**, meaning at least 10% of the tumor cells show this characteristic when tested.
  • The cancer must be **HER2-negative**, which means it has a low score on specific tests (IHC score 0 or 1+, or IHC score 2+ with further negative tests).
  • Normal blood function is required, with specific levels for white blood cells (ANC ≥ 1,500/mm³), platelets (≥ 100,000/mm³), and hemoglobin (> 9 g/dl).
  • Normal liver function is required, with specific limits for bilirubin (≤ 1.25 times the upper limit of normal), ASAT and ALAT (≤ 1.5 times the upper limit of normal), and alkaline phosphatases (≤ 3 times the upper limit of normal).

Who cannot join the trial?

4 criteria

  • Patients who do not have **oestrogen-receptor (ER)-positive HER2-negative breast carcinoma**. This means the cancer must be sensitive to hormones and not have a specific protein called HER2.
  • Patients who are not considered elderly. The study is focused on older patients.
  • Patients who are male. The study is only for female patients.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

  • Chemotherapy

    is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is being evaluated to see if it can improve overall survival in elderly patients with a high risk of breast cancer relapse. The specific drugs used in chemotherapy can vary, but they generally work by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing.

  • Endocrine Treatment

    is a therapy used to treat breast cancer by blocking or lowering the amount of hormones in the body. This is particularly effective for oestrogen-receptor (ER)-positive breast cancer, as these cancer cells need oestrogen to grow. Endocrine treatment can involve medications that block the hormone receptors on cancer cells or reduce the production of hormones in the body.

What is already known about the treatment

Letrozole – Letrozole is administered orally in tablet form and is primarily used in the treatment of hormone receptor-positive breast cancer, particularly in postmenopausal women. It is well-established in medical literature as an effective endocrine therapy for breast cancer, often used in combination with other treatments. The main therapeutic indication for Letrozole is to reduce the risk of cancer recurrence by lowering estrogen levels in the body. At the molecular level, it works by inhibiting the aromatase enzyme, which is responsible for converting androgens into estrogens, thereby decreasing estrogen production. Letrozole is classified as an aromatase inhibitor in pharmacology.

Investigated diseases

Estrogen Receptor-Positive HER2-Negative Breast Carcinoma – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells, which means the cancer cells may receive signals from estrogen that could promote their growth. It is also HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surfaces. This subtype of breast cancer tends to grow more slowly than other types and may respond well to hormone therapy. The progression of the disease can vary, with some cases remaining localized while others may spread to nearby tissues or distant parts of the body. The risk of recurrence and progression is often assessed using genomic grading and other factors.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-516996-34-00Protocol codeUC-0103/1102Estimated enrolment1 989 patientsSponsorUnicancer

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