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Study on Chemotherapy and Aromatase Inhibitors (Exemestane, Letrozole, Anastrozole) for Post-Menopausal Patients with Early Breast Cancer

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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 the treatment of breast cancer, which is the most common cancer among women in North America, Europe, and Latin America. The study involves post-menopausal women with early-stage breast cancer that responds to hormones. The trial is comparing two different ways of giving treatment: giving chemotherapy and aromatase inhibitors at the same time (concurrent) versus one after the other (sequential). Aromatase inhibitors are medications that help lower estrogen levels in the body, which can slow the growth of certain types of breast cancer. The specific aromatase inhibitors being studied are exemestane, letrozole, and anastrozole.

The purpose of the study is to find out which method of treatment is more effective in preventing the cancer from coming back. Participants will receive either the concurrent or sequential treatment over a period of time, and their health will be monitored to see how well the treatment works. The study will also look at the safety of the treatments and any side effects that may occur. Some participants may receive a placebo as part of the study.

The trial will follow participants for several years to gather information on the long-term effects of the treatments. This includes tracking the time until any recurrence of the disease, the development of any new cancers, and overall survival. The study aims to provide valuable insights into the best way to combine chemotherapy and hormone therapy for women with hormone-responsive breast cancer.

The research process

The trial runs in 6 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 postmenopausal status and a diagnosis of early breast cancer that has been completely removed by surgery.

    The study involves women who are prescribed 5 years of endocrine therapy with an aromatase inhibitor and have an indication for additional chemotherapy.

  2. Step 2

    Treatment plan

    The study compares two treatment approaches: concurrent and sequential administration of chemotherapy and aromatase inhibitors.

    Aromatase inhibitors used in the study include exemestane, letrozole, and anastrozole, all taken orally.

  3. Step 3

    Chemotherapy administration

    Chemotherapy is administered as part of the treatment plan. The timing of chemotherapy in relation to the aromatase inhibitors is a key focus of the study.

  4. Step 4

    Aromatase inhibitor administration

    Aromatase inhibitors are taken orally as part of the treatment regimen. The study evaluates the effectiveness of these medications in preventing the recurrence of breast cancer.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for disease recurrence, which includes local, regional, or distant recurrence, as well as the development of new breast cancer or other primary malignancies.

    Safety is assessed through clinical and laboratory evaluations, with toxicities graded according to established criteria.

  6. Step 6

    Study duration

    The study is expected to continue until November 15, 2034, with ongoing assessments of treatment efficacy and safety.

Who can join the trial?

10 criteria

  • Women who have been diagnosed with invasive breast cancer that has been completely removed by surgery.
  • Women who are **postmenopausal**. This means they have stopped having menstrual periods. This can be confirmed if they are:
    • 60 years old or older.
    • Between 45 and 59 years old and meet one of these conditions:
      • Have not had a period for 12 months and have an intact uterus.
      • Have not had a period for less than 12 months, but a blood test shows they are postmenopausal. This includes women who have had a hysterectomy (removal of the uterus), have taken hormone replacement therapy (HRT), or have stopped having periods due to chemotherapy.
      • Have had both ovaries removed (bilateral oophorectomy) at any age over 18.
      • The primary tumor must be positive for **ER** (estrogen receptor) and/or **PgR** (progesterone receptor). This means that at least 1% of the tumor cells test positive in a specific lab test.
      • Patients must be prescribed 5 years of **endocrine therapy** with an **AI** (aromatase inhibitor), which is a type of medication used to treat breast cancer.
      • There must be a need for additional treatment after surgery, known as **adjuvant chemotherapy**.
      • Patients with tumors that are **HER-2 positive** can participate if they are prescribed **trastuzumab**, a medication used to treat this type of cancer, according to the recommended schedule.
      • Participants must sign an **informed consent** form, which means they agree to take part in the study after being informed about all aspects of the trial.

Who cannot join the trial?

2 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • Chemotherapy

    is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this trial, chemotherapy is being used to treat early breast cancer in post-menopausal patients.

  • Aromatase Inhibitors

    are a class of drugs used in the treatment of breast cancer in post-menopausal women. They work by lowering the amount of estrogen in the body, which can help slow or stop the growth of hormone-sensitive tumors. In this study, aromatase inhibitors are being used as part of the adjuvant treatment to prevent the recurrence of breast cancer.

What is already known about the treatment

Aromatase Inhibitors – These medications are typically administered orally in pill form. They are currently well-established in medical practice and literature, particularly for treating hormone receptor-positive breast cancer in post-menopausal women. Aromatase inhibitors work by blocking the enzyme aromatase, which is responsible for converting androgens into estrogens in the body, thereby reducing estrogen levels and slowing the growth of estrogen-dependent cancer cells. They are classified as hormone therapy agents and are often used in combination with chemotherapy to prevent cancer recurrence.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It is the most common cancer among women in North America, Europe, and Latin America. Most breast cancers are endocrine-responsive, meaning they grow in response to hormones like estrogen. The disease can progress locally within the breast or spread to nearby lymph nodes and other parts of the body. The progression can vary, with some tumors growing slowly over years, while others may develop more rapidly. Understanding the hormonal nature of the tumor is crucial for determining the appropriate treatment approach.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519087-41-00Protocol codeGIM10-CONSENTEstimated enrolment1 014 patientsSponsorIRCCS Ospedale Policlinico San Martino

sourced from the EU Clinical Trials Register and site verification

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