NCT00129896

Brief Summary

This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH). Phase I: Initial doses will be: Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and Herceptin (4) 2 mg/kg weekly. Sample size will depend on the number of patients recruited during dose escalation. Three patients must be recruited in each dose level. If one out of three experiences a dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level. Considering that there are 4 dose levels to be tested, the estimated number of patients is 9 to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

16 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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

4.9 years

First QC Date

August 11, 2005

Last Update Submit

March 3, 2023

Conditions

Breast Cancer

Keywords

Her2neu positive breast cancer.Neoadjuvant treatment.

Outcome Measures

Primary Outcomes (2)

  • Tolerability (Phase I): Recommended Doses of the combination treatment

    Recommended Doses of the combination treatment

    up to 24 months since last patient included in the Phase I

  • Efficacy (Phase II): Percentage (%) pathological Complete Response achieved according to Miller and Payne Criteria

    % pathological Complete Response achieved according to Miller and Payne Criteria

    up to 24 months since last patient included in the Phase II

Secondary Outcomes (6)

  • Clinical response rates

    up to 6 months since last patient treatment

  • Surgery type (conservative surgery versus mastectomy)

    up to 7 months since last patient treatment

  • Potential cardiac toxicity

    up to 12 months since last patient included

  • Safety: Adverse Events evaluated according to NCI CTC v2.0

    24 months since last patient included

  • Post-surgery node status

    up to 7 months since last patient treatment

  • +1 more secondary outcomes

Study Arms (1)

Myocet+Taxotere+Herceptin

EXPERIMENTAL

Myocet 50 mg/m2; Taxotere 60 mg/m2; Herceptín 4 mg/Kg (first dose) and in the following cycles 2 mg/Kg

Drug: MyocetDrug: TaxotereDrug: Herceptin

Interventions

MyocetDRUG

Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles

Also known as: Lyposomal Doxorubicin
Myocet+Taxotere+Herceptin
TaxotereDRUG

Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles

Also known as: Docetaxel
Myocet+Taxotere+Herceptin
HerceptinDRUG

Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles

Also known as: Trastuzumab
Myocet+Taxotere+Herceptin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Breast cancer stages II and IIIA with histological diagnoses by true-cut.
  • Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH.
  • No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
  • Estrogen and progesterone hormone receptor status, determined before study registration.
  • Age \>= 18 years old.
  • Performance status (Karnofsky index) \>= 80.
  • Adequate cardiac function by LVEF in the previous 14 days.
  • Hematology: neutrophils \>= 2.0 x10\^9/l; platelets \>= 100 x10\^9/l; hemoglobin \>= 10 g/dl.
  • Adequate hepatic function: total bilirubin \<= 1x upper normal limit (UNL); SGOT and SGPT \<= 2.5xUNL; alkaline phosphatase \<= 2.5xUNL.
  • Adequate renal function: creatinine \<= 1xUNL; creatinine clearance \>= 60 ml/min.
  • Patients able to comply with study treatment and follow-up.
  • Negative pregnancy test in the previous 14 days.
  • Adequate contraceptive method during the study and up to 3 months after definitive surgery.

You may not qualify if:

  • HER2neu negative tumours.
  • Prior systemic therapy for breast cancer.
  • Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women.
  • Previous grade \>= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]).
  • Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Chronic treatment with corticosteroids.
  • Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates.
  • Concomitant treatment with other therapy for cancer.
  • Males.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital Universitario Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Althaia-Xarxa Assistencial de Manresa

Manresa, Barcelona, 08243, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipúzcoa, 20012, Spain

Location

Hospital de la Ribera

Alzira, Valencia, 46600, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27004, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (2)

  • Anton A, Ruiz A, Plazaola A, Calvo L, Segui MA, Santaballa A, Munoz M, Sanchez P, Miguel A, Carrasco E, Lao J, Camps J, Alfaro J, Antolin S, Camara MC. Phase II clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neoadjuvant treatment in stages II and IIIA HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol. 2011 Jan;22(1):74-79. doi: 10.1093/annonc/mdq317. Epub 2010 Jul 5.

    PMID: 20603435RESULT

  • Anton A, Ruiz A, Segui MA, Calvo L, Munoz M, Lao J, Sancho F, Fernandez L. Phase I clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neo-adjuvant treatment in stages II and IIIA, HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol. 2009 Mar;20(3):454-9. doi: 10.1093/annonc/mdn663. Epub 2008 Dec 11.

    PMID: 19074216RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DoxorubicinDocetaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Study Director

    Hospital Univesitario Miguel Servet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2008

Study Completion

February 1, 2010

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

ES(16)