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Study on the Effect of Tamoxifen and Chemotherapy in Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with Low Recurrence Scores

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 breast cancer, specifically in patients who have a type of breast cancer that is hormone receptor-positive and HER2-negative. These patients have 1 to 3 positive lymph nodes and a Recurrence Score of 25 or less, which is determined by a test called Oncotype DX. The trial aims to understand the effect of adding chemotherapy to standard hormone therapy, also known as endocrine therapy, in these patients.

The study involves several medications. For hormone therapy, patients may receive tamoxifen, anastrozole, exemestane, or letrozole, all of which are taken orally in tablet form. For chemotherapy, the medications include doxorubicin, cyclophosphamide, docetaxel, paclitaxel, epirubicin, and fluorouracil. These are administered through injections or infusions directly into the bloodstream. Some patients will receive a placebo instead of chemotherapy to compare the outcomes.

The purpose of the study is to determine if the benefit of chemotherapy depends on the Recurrence Score. Participants will be randomly assigned to receive either hormone therapy alone or hormone therapy with chemotherapy. The study will monitor the patients over time to see how the treatments affect their cancer, focusing on how long they remain free of invasive cancer and their overall survival. The trial will help determine the best treatment approach for patients with this specific type of 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

    Registration and initial assessment

    Upon joining the study, a complete history and physical examination will be conducted within 28 days prior to registration. This is to ensure eligibility and gather baseline health information.

    Patients must have a confirmed diagnosis of node-positive breast cancer with specific characteristics, including positive estrogen and/or progesterone receptor status and negative HER-2 status.

    Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.

  2. Step 2

    Oncotype DX® screening

    If not already completed, the Oncotype DX® test will be conducted to determine the Recurrence Score (RS). This score helps assess the risk of cancer returning and guides treatment decisions.

    Registration for patients who have not undergone Oncotype DX® screening must occur no later than 56 days after definitive surgery. If the RS is 25 or less, the patient proceeds to the next step.

  3. Step 3

    Treatment assignment

    Patients will be randomly assigned to receive either standard adjuvant endocrine therapy alone or in combination with chemotherapy.

    The decision to include chemotherapy is based on the Recurrence Score and other factors determined by the study protocol.

  4. Step 4

    Endocrine therapy

    Endocrine therapy involves taking medication orally to block hormones that can promote cancer growth. Medications may include tamoxifen, anastrozole, exemestane, or letrozole.

    The specific medication, dosage, and duration will be determined by the study protocol and the patient's individual health needs.

  5. Step 5

    Chemotherapy (if assigned)

    If assigned to receive chemotherapy, patients will undergo treatment with medications administered through intravenous (IV) infusion. These may include doxorubicin, cyclophosphamide, docetaxel, paclitaxel, epirubicin, or fluorouracil.

    The frequency and duration of chemotherapy sessions will be specified in the study protocol.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up appointments will be scheduled to monitor health status, manage any side effects, and assess the effectiveness of the treatment.

    Patients will be evaluated for disease-free survival, overall survival, and any recurrence of cancer.

Who can join the trial?

16 criteria

  • Patients must have a confirmed diagnosis of breast cancer that has spread to 1-3 lymph nodes, with positive estrogen and/or progesterone receptor status, and negative for HER-2 (a protein that can affect the growth of cancer cells).
  • Patients must be able to receive chemotherapy treatments that include taxane and/or anthracycline (types of cancer-fighting drugs).
  • Patients must not have started chemotherapy or hormone therapy for their breast cancer before joining the study.
  • Patients must not need long-term treatment with systemic steroids (medications that reduce inflammation) or other drugs that suppress the immune system. Inhaled steroids are allowed.
  • Patients must not have taken an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) like tamoxifen or raloxifene within 5 years before joining the study.
  • Patients must not be pregnant or breastfeeding, as the treatment could harm a fetus or nursing baby. Women who can become pregnant must agree to use effective birth control methods.
  • Patients must not have had any other cancer, except for certain skin cancers or cervical cancer that has been treated and disease-free for 5 years.
  • Patients must be informed about the study and must sign a consent form agreeing to participate.
  • Patients with multiple areas of cancer in one or both breasts are allowed.
  • Patients must have had a procedure to check the lymph nodes under the arm, either by sentinel node biopsy or axillary lymph node dissection (ALND).
  • Patients must not have inflammatory breast cancer or cancer that has spread to other parts of the body. Patients with a previous diagnosis of DCIS (a non-invasive breast cancer) are eligible if they had a mastectomy without additional treatments like radiation or hormone therapy.
  • Patients must have had either breast-conserving surgery with planned radiation therapy or a total mastectomy, with clear margins as per local guidelines.
  • Patients who have not yet had Oncotype DX® screening must join the study within 56 days after surgery. If the Recurrence Score is known and is 25 or less, they must join the next step of the study immediately. If the score is greater than 25, they are not eligible.
  • Patients must be women aged 18 years or older. Men are not eligible for this study.
  • Patients must have a complete medical history and physical examination within 28 days before joining the study.
  • Patients must have a performance status of 0-2 by Zubrod criteria (a scale that measures a patient's ability to perform daily activities).

Who cannot join the trial?

6 criteria

  • Patients who have a high **Recurrence Score (RS)** by **Oncotype DX** cannot participate. The **Recurrence Score** is a test that predicts the chance of breast cancer returning.
  • Only patients with **1-3 positive nodes** can participate. **Nodes** refer to lymph nodes, which are small glands that help fight infection.
  • Patients must have **hormone receptor (HR)-positive** breast cancer. This means the cancer grows in response to hormones.
  • Patients must have **HER2-negative** breast cancer. **HER2** is a protein that can affect the growth of cancer cells.
  • Only female patients are eligible to participate.
  • Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who may need special protection.
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Investigated drugs

  • Endocrine Therapy

    is a treatment used to block or lower the amount of hormones in the body to slow down or stop the growth of cancer. In this trial, it is used for patients with hormone receptor-positive breast cancer. This means that the cancer cells grow in response to hormones like estrogen or progesterone. By using endocrine therapy, the goal is to prevent these hormones from helping the cancer grow.

  • 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 tested to see if it provides additional benefits to patients who are already receiving endocrine therapy. The trial aims to find out if adding chemotherapy can improve the chances of staying cancer-free for patients with certain types of breast cancer.

What is already known about the treatment

  • Standard Adjuvant Endocrine Therapy

    This medication is typically administered orally or as an injection, depending on the specific drug used within this category. It is currently well-established in medical practice and literature for treating hormone receptor-positive breast cancer. The main therapeutic indication is to reduce the risk of cancer recurrence in patients with certain types of breast cancer. At the molecular level, it works by blocking or lowering the amount of hormones like estrogen that can promote the growth of cancer cells. It is classified pharmacologically as a hormone therapy.

  • Chemotherapy

    Chemotherapy is usually given intravenously, allowing the medication to enter the bloodstream and reach cancer cells throughout the body. It is a standard treatment in oncology, widely documented in medical literature for its role in treating various cancers, including breast cancer. The primary therapeutic indication is to kill or slow the growth of cancer cells. At the molecular level, chemotherapy targets rapidly dividing cells, interfering with their ability to grow and divide. It is classified as an antineoplastic or anticancer drug.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The progression can vary, with some cancers growing slowly and others more rapidly. Hormone receptor-positive and HER2-negative types are specific subtypes that influence how the disease behaves. The recurrence of breast cancer can occur locally in the breast or distantly in other organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515368-29-00Protocol codeGEICAM/2011-03_S1007Estimated enrolment792 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

sourced from the EU Clinical Trials Register and site verification

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