Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

NCT ID: NCT00615602

Last Updated: 2015-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2012-05-31

Brief Summary

This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2

Detailed Description

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

FEC -\> TXT+H 12m

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles

Trastuzumab

Intervention Type: DRUG

Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months

Epirubicin

Intervention Type: DRUG

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

5-fluoruracil

Intervention Type: DRUG

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

Granulocyte-colony stimulating growth factor

Intervention Type: DRUG

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

2

FEC -\> TXT+H 6m

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles

Epirubicin

Intervention Type: DRUG

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

5-fluoruracil

Intervention Type: DRUG

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

Granulocyte-colony stimulating growth factor

Intervention Type: DRUG

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Trastuzumab

Intervention Type: DRUG

Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months

Interventions

Docetaxel

Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles

Intervention Type: DRUG

Trastuzumab

Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months

Intervention Type: DRUG

Epirubicin

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

Intervention Type: DRUG

5-fluoruracil

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

Intervention Type: DRUG

Granulocyte-colony stimulating growth factor

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Intervention Type: DRUG

Trastuzumab

Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months

Intervention Type: DRUG

Other Intervention Names

Taxotere; Herceptin; Farmorubicin; Endoxan; 5-FU; Granocyte; Neulasta; Herceptin

Eligibility Criteria

Inclusion Criteria

• Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
• HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
• Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
• Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible)
• Absence of any clinical or radiological evidence of local or metastatic disease
• Premenopausal or postmenopausal women aged 18-75 years old
• Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
• Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
• Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
• Written informed consent

Exclusion Criteria

• Positive pregnancy test.
• Psychiatric illness or social situation that would preclude study compliance.
• Other concurrent uncontrolled illness.
• Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
• Previous history of other invasive malignancy other than non-melanomatous skin cancer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Mavrudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University Hospital of Crete

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, , Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, , Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/04.23

Identifier Type: -

Identifier Source: org_study_id