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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Fundacion Onkologikoa Fundazioa	Donostia / San Sebastian	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Centro Oncologico De Galicia	A Coruna Galicia	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Idwiirxe Cvilfv Dqqycuxzwklfvucsp	L'hospitalet De Llobregat	Spain
Htijvttt Uvulrcpkwjszy Dyzptrly	Donostia / San Sebastian	Spain
Hsnlseim Dh Lp Suwad Cwmo I Soot Pow	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	20.09.2012

Trial locations

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.

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 ID:

2024-515368-29-00

Protocol code:

GEICAM/2011-03_S1007

NCT ID:

NCT01272037

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?