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 General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario De Leon Leon Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Consorci Sanitari De Terrassa Terrassa Spain
Hospital General Universitario De Albacete Albacete Spain
Caarkz Oyjvceukjz Dr Gjypniz A Coruna Galicia Spain
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Hoqenjij Dw Ly Sarae Crzd I Sltv Pjc Barcelona Spain
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Iedozviy Ckeqcz Dvyabdjjwmsalgbaa L'hospitalet De Llobregat Spain
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Fbjvtdese Ixpjsenih Voozwxczfv Dv Opbbavpbd Valencia Spain
Hfigmdfu Cfonigt Uuvxtlxptrdkk Lqayqw Bhsrs Zaragoza Spain
Clatuoda Hohwdqfuhrgh Uyysblbsehocp Dv Vcqo Vigo Spain
Hdkxafbd Ugyhjzglgphss Vzsdxm Dg Lzp Nftncg Granada Spain
Hkyrjyco Uuravxztuxdel Vxxmmy Dq Lv Vlwbubwu Malaga Spain
Pqkl Tiwch Hhouvsym Usmhixmwawyl Sabadell Spain
Cbodzhace Huskbics Gulzbgj Uuyafxqglahmm Dt Vwllpyte Castello De La Plana Spain
Hetihgay Ukjlidsgcvzvy Ajdbl Vitoria Spain
Hsvyttza Ugwphjtdytvxq Vbblzq Db Vdlao Sevilla Spain
Hvhkrgvg Umfvhsascihgr Dkowtiie Donostia / San Sebastian Spain
Hkpxljqx Uczsfkhhiywqs Lcbta Awirzwa Lugo Spain
Fznhnhxm Aqgkijwjjdao Da Mkxtc Dt Tfxrktqr Fwp Terrassa Spain
Fhtljtzz Dw Romfdgp Cucpuy Bivtjabqnvyidfbfaa Dixdbicfdglialcg Bwsinoachht Auagey Pz I Sjthtr Barcelona Spain
Hknnshva Utdbaaqbvjuec Ppnpdv Dlb Mih Cadiz Spain
Hvxjbcay Ghmfpsh Uayzwuivocufn Mdhmxcd Mcdpzvuq Murcia Spain
Hbebrjtf Uuzrjmdemmtci Dt Bsjrquq Badajoz Spain
Auxm Dh Scouy Dj Bmmjgn Y Srekj Burgos Spain
Hqvhzubc Uagcipsxtqjqf Dx Jrex Jaen Spain
Hfzvmrub Uzqhwhpzatogx Bqeimnj Bilbao Spain
Hbqnznms Ukpjaaecrqkto Dg Pqdrv Aiqfslyqdq Valencia Spain
Hrsnhgfs Dp Sesepcj Sagunto Spain
Hhocgyxa Vtpcjn Dj Lvx Lsezja Alcoy Spain
Ffxwagsfd Oohcsanefjv Fvvhxyqex Donostia / San Sebastian Spain
Apfpbkj Xsrlj Awojygofeabr Umglxsmtxkwdj Dl Mmizxkq Frtdkwlm Psnjzjt Manresa Spain
Hbnnvnwd Uajzrdqwrawji Habessas Tbhhn y Poefck Iexiubnf Cqzakz dltbllzghfkyojbaj (fcdp Badalona 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

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.

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

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