Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

Hellenic Oncology Research Group

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Docetaxel; Drug: Granulocyte-colony stimulating growth factor; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: 5-fluoruracil

Study type: Interventional

Funder types: Other

Identifiers

NCT01985724

CT/07.17

Details and patient eligibility

About

In this trial investigators propose to assess the dose dense, G-CSF supported sequential administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary lymph node positive breast cancer

Full description

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. At least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative 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.

Data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.

Enrollment: 650 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
• 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
• 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%)
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

A

Active Comparator group

Description:

FEC -\> TXT

Treatment:

Drug: 5-fluoruracil

Drug: Epirubicin

Drug: Cyclophosphamide

Drug: Granulocyte-colony stimulating growth factor

Drug: Docetaxel

B

Experimental group

Description:

Docetaxel/Cyclophosphamide (TC)

Treatment:

Drug: Cyclophosphamide

Drug: Granulocyte-colony stimulating growth factor

Drug: Docetaxel