Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

Lucia Del Mastro,MD

Status and phase: Completed; Phase 2

Conditions: HER-2 Positive Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01340430

2010-021600-24 (EudraCT Number)

NEOHER-021

Details and patient eligibility

About

The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1

2. Histologically confirmed invasive breast cancer,

3. Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,

4. Any N,

5. No evidence of metastasis (M0);

6. Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:

7. 3+ over expression by immunohistochemistry (IHC) (> 30% of invasive tumour cells),

8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,

9. Her 2 gene amplication by FISH/CISH (ratio > 2.2);

10. Known hormone receptor status

11. Hematopoietic status:

    1. absolute neutrophil count ≥ 1.5 x 109/L,
    2. platelet count ≥ 100 x 109/L,

12. Hepatic status:

    1. serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a higher serum total bilirubin (< 2 x ULN) is allowed,
    2. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
    3. alkaline phosphatase ≤ 2.5 times ULN;

13. Renal status:

    a. Creatinine ≤ 2.0 mg/dL;

14. Cardiovascular:

    a. baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);

15. For women of childbearing potential negative serum pregnancy test

16. Written informed consent.

Exclusion Criteria:

1. Male gender
2. Pregnant or lactating women
3. Received any prior treatment for primary invasive breast cancer
4. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
5. Active or uncontrolled infection,
6. Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
7. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
8. Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
9. Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

FEC-paclitaxel-trastuzumab

Experimental group

Description:

fluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks

Treatment:

Drug: Trastuzumab