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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

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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 2 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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