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Long-Term Study on Early Stage Breast Cancer Patients Using Capecitabine, Gemcitabine, and Paclitaxel

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What is this trial about?

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

This clinical trial focuses on patients with invasive breast cancer in its early stages. The study aims to observe the long-term progress of these patients, particularly looking at the frequency, type, and location of the first return of the disease, known as a relapse. The trial includes patients who have participated in previous studies conducted by GEICAM, a research group specializing in breast cancer. The study will gather information on the dates of disease relapse, the occurrence of new primary tumors, and survival rates without events related to cancer.

The trial involves several treatments that have been used in previous studies. These include Xeloda (capecitabine), Gemcitabina Accord (gemcitabine), Paclitaxel Hospira (paclitaxel), Aromasil (exemestane), Faslodex (fulvestrant), Zoladex (goserelin acetate), Abraxane (paclitaxel albumin-bound), TAXOTERE (docetaxel), Myocet (doxorubicin hydrochloride), lapatinib, Ofev (nintedanib), Carboplatin, and Herceptin (trastuzumab). These medications are used in various forms, such as tablets, injections, and infusions, to treat breast cancer.

The purpose of this study is to understand how patients with early-stage invasive breast cancer progress over time after receiving these treatments. The study will monitor patients for any signs of the disease returning and will also record survival rates. This information will help researchers and doctors better understand the long-term effects of these treatments and improve future care for breast cancer patients.

The research process

The trial runs in 4 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, the patient will be informed about the purpose and procedures involved in the trial. The study aims to observe the long-term progress of patients with early-stage invasive breast cancer who have participated in previous GEICAM studies.

  2. Step 2

    Medication administration

    The patient may receive various medications as part of the study. These include capecitabine in the form of 500 mg film-coated tablets taken orally, gemcitabine as a solution for infusion, and paclitaxel as a solution for infusion. Other medications include exemestane in 25 mg coated tablets taken orally, fulvestrant as a solution for injection, and goserelin acetate as a subcutaneous implant.

    Additional medications may include paclitaxel albumin-bound as a dispersion for infusion, docetaxel as a solution for infusion, doxorubicin hydrochloride as a dispersion for infusion, lapatinib in capsule form, nintedanib in soft capsules, carboplatin as a solution for infusion, and trastuzumab as a solution for infusion.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the patient's health will be monitored regularly to track the frequency, type, and location of any cancer relapse. This includes local, regional, or distant relapses, as well as the occurrence of any second primary tumors.

    The study will also record the patient's overall survival and any events related to breast cancer. This information will help in understanding the long-term outcomes of the treatments received.

  4. Step 4

    End of study

    The study is expected to continue until November 15, 2048. During this time, the patient's data will be collected and analyzed to contribute to the understanding of breast cancer treatment outcomes.

Who can join the trial?

6 criteria

  • Patients must have invasive breast cancer in the early stages. This means the cancer has spread into surrounding breast tissue but not to distant parts of the body.
  • Patients must have been included in neoadjuvant or adjuvant clinical trials with GEICAM's participation. Neoadjuvant treatment is given before the main treatment, and adjuvant treatment is given after the main treatment to lower the risk of the cancer coming back.
  • If patients have participated in another clinical trial, they are still eligible for this study, and their information will be collected.
  • Patients whose death or loss of contact has not been previously recorded in the original study databases are eligible.
  • Only female patients are eligible for this study.
  • Patients should not be part of a vulnerable population, meaning they should not be in a group that might have difficulty giving informed consent or be at higher risk of harm.

Who cannot join the trial?

3 criteria

  • Patients who do not have invasive breast cancer in early stages cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

  • Paclitaxel albumin‑bound

    is a chemotherapy drug that is given through an IV infusion. It uses a protein carrier to help the medication reach cancer cells more effectively. In this study it is being tested as part of the treatment plan for early‑stage breast cancer.

  • Exemestane

    is an oral hormone therapy taken as a tablet. It works by lowering estrogen levels in the body, which can help slow the growth of breast cancers that need estrogen to grow. In the trial it is used as a test medication.

  • Docetaxel

    is a chemotherapy medication given by IV infusion. It attacks rapidly dividing cells, including cancer cells, and is used to shrink tumors before surgery or after surgery. In this study it is included as a test drug.

  • Nintedanib

    is an oral capsule that blocks several signals that help tumors grow new blood vessels. By limiting blood supply, it may slow tumor growth. It is being evaluated as a test therapy in the trial.

  • Goserelin acetate

    is a tiny implant placed under the skin that releases medication over time. It suppresses the body’s production of hormones that can stimulate certain breast cancers. In the study it serves as a test hormone‑blocking therapy.

  • Doxorubicin hydrochloride

    (liposomal formulation) is a chemotherapy drug given as an IV infusion. The liposome helps deliver the drug directly to cancer cells while reducing side effects. It is used as a test medication in the trial.

What is already known about the treatment

  • Abraxane

    This medication is given as a powder that is mixed with liquid and infused into a vein. It is an approved cancer drug used mainly for breast cancer and works by attaching to tiny protein particles that help deliver the drug to tumor cells, where it stops the cells from dividing. It belongs to the taxane class of chemotherapy agents. It is widely studied and listed in medical guidelines for breast cancer treatment.

  • Aromasil

    This drug comes as a coated tablet taken by mouth. It is an approved aromatase inhibitor used to treat hormone‑sensitive breast cancer by lowering estrogen levels in the body. It works by blocking an enzyme that makes estrogen, which helps slow tumor growth. It is a standard therapy in many breast‑cancer treatment plans.

  • TAXOTERE

    TAXOTERE is supplied as a concentrate that is mixed with fluid and given by intravenous infusion. It is an approved chemotherapy drug for breast cancer and works by binding to cell structures called microtubules, preventing cancer cells from dividing. It is classified as a taxane chemotherapy. It has extensive use and is referenced in many clinical studies.

  • Ofev

    Ofev is provided as soft capsules taken orally. It is an approved medication for certain lung diseases but is also studied in breast cancer for its ability to block several enzymes that help tumors grow new blood vessels. It works by inhibiting multiple kinases that signal cells to multiply. It belongs to the class of tyrosine‑kinase inhibitors and is listed in current medical literature.

  • Zoladex

    Zoladex is a small implant placed under the skin that releases medication over time. It is approved for hormone‑sensitive breast cancer and works by mimicking a hormone that tells the body to stop making other hormones that can fuel tumor growth. It is a gonadotropin‑releasing hormone (GnRH) agonist. It is widely used and described in treatment guidelines.

  • Myocet

    Myocet is a liposomal form of doxorubicin that is mixed with liquid and given by intravenous infusion. It is an approved chemotherapy for breast cancer and works by slipping into cancer cells and damaging their DNA, which stops them from growing. It belongs to the anthracycline class of chemotherapy agents. It is a well‑known drug with many studies supporting its use.

Investigated diseases

Invasive Breast Cancer – Invasive breast cancer is a type of cancer that begins in the breast tissue and spreads beyond the original site. It typically starts in the milk ducts or lobules and invades surrounding breast tissue. As the disease progresses, cancer cells can enter the lymphatic system or bloodstream, potentially spreading to other parts of the body. The progression of invasive breast cancer can vary, with some cases remaining localized for extended periods, while others may spread more rapidly. The disease is characterized by the formation of a lump or mass in the breast, changes in breast shape, or skin alterations. Over time, it may lead to the involvement of regional lymph nodes and distant organs.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502706-33-00Protocol codeGEICAM/2016-03Estimated enrolment8 000 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

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