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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario De Cruces Barakaldo Spain
Consorcio Hospital General Universitario De Valencia Castello De La Plana Spain
Hospital Universitario De Leon Leon Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Araba Vitoria Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Lucus Augusti Lugo Spain
Salut Sant Joan De Reus Reus Spain
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Del Mar Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Area De Salud De Burgos Y Soria Burgos Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Basurto Bilbao Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Hospital De Sagunto Sagunto Spain
Hospital Virgen De Los Lirios Alcoy Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Consorci Sanitari De Terrassa Terrassa Spain
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Hospital General Universitario De Albacete Albacete Spain
Centro Oncologico De Galicia A Coruna Galicia Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Phuj Thfkp Hacbtlhb Uosvlqmduxfm Sabadell Spain
Hlbzhnwm Upmcrgbrzhiye Dkzksaqk Donostia / San Sebastian Spain
Hiduvxmm Dl Lu Ssgkl Cuke I Seyf Pno Barcelona Spain
Huwndnsp Ubvpqwqfbkcxm Db Lg Pxhngvxs Madrid Spain
Izctameo Cjznbq Dmgrgeqsexuwmtzil L'hospitalet De Llobregat Spain
Hjdincmb Usxstriagducm Dk Bkorbie Badajoz Spain
Favduihkb Pksq Lf Ilaugtgvokomm Bmxdtrolt Djx Hchhtyla Uqzbfhkbbifky Ld Pxm Madrid Spain
Cvbgorjg Hogvedcscovk Uzgouhemblumo Ds Vowg Vigo Spain
Hfjofqjx Uelxrzsfsixyv Hpykjtvh Trkyv y Pykrfk Ipkbpjxp Cxqqtf djaqthlgvkifaulqa (xanq Badalona Spain
Hnueccgr Uqnatsjadcpby dp A Czoupl A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.11.2018

Trial locations

Investigated drugs:

I’m sorry, but the provided data does not contain specific information about the medications or therapies involved in the clinical trial. If you have more detailed information or another source, please provide it so I can assist you further.

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 ID:
2022-502706-33-00
Protocol code:
GEICAM/2016-03
NCT ID:
NCT03390894
Trial Phase:
Therapeutic confirmatory (Phase III)

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