NCT00128856

Brief Summary

This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

11.8 years

First QC Date

August 9, 2005

Last Update Submit

March 3, 2023

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapy.Stage III disease.

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response (pCR) rate

    pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.

    Up to week 15

Secondary Outcomes (5)

  • Overall response rate (ORR)

    Up to week 12

  • Conservative surgery rate

    Up to week 15

  • The Number of Participants Who Experienced Adverse Events (AE)

    Through study treatment up to surgery

  • Disease-free survival

    Up to 5 years since surgery

  • Tissue molecular markers and their correlation with response

    Up to week 15

Study Arms (1)

Gemcitabine + Adriamycine + Paclitaxel

EXPERIMENTAL

Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.

Drug: GemcitabineDrug: AdriamycineDrug: Paclitaxel

Interventions

GemcitabineDRUG
Also known as: Gemzar
Gemcitabine + Adriamycine + Paclitaxel
AdriamycineDRUG
Also known as: doxorubicin
Gemcitabine + Adriamycine + Paclitaxel
PaclitaxelDRUG
Also known as: Taxol
Gemcitabine + Adriamycine + Paclitaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
  • Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
  • Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
  • Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
  • At least a 6 month life expectancy.
  • Neutrophils \> 1500; platelets \> 100000; haemoglobin \> 10 mg/dL.
  • Adequate renal and hepatic functions, with serum creatinine \< 1.2 mg/dl and total bilirubin \< 2 mg/dl.
  • Adequate contraceptive methods during the study and up to 3 months after.
  • Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction \> 55%.

You may not qualify if:

  • Inflammatory carcinoma or stage I, II or IV breast cancer disease.
  • Males.
  • Active infection.
  • Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
  • Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
  • Pre-existing motor or sensorial neuropathy \> grade 1.
  • Inability for treatment compliance.
  • History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
  • History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
  • History of myocardial infarction in the previous 6 months.
  • Hypertension not controlled.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Complejo Hospitalario Unviesitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

  • Sanchez-Rovira P, Anton A, Barnadas A, Velasco A, Lomas M, Rodriguez-Pinilla M, Ramirez JL, Ramirez C, Rios MJ, Castella E, Garcia-Andrade C, San Antonio B, Carrasco E, Palacios JL. Classical markers like ER and ki-67, but also survivin and pERK, could be involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4.

    PMID: 22634531RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsDisease

Interventions

GemcitabineDoxorubicinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Study Director

    Hospital Miguel Servet

    STUDY DIRECTOR

  • Study Director

    Complejo Hospitalrio de Jaén

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 10, 2005

Study Start

March 1, 2003

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

ES(10)