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

HER-2 Positive Breast Cancer Clinical Trial

Official title:

Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340430
• Other study ID #: NEOHER-021
• Secondary ID: 2010-021600-24
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: January 2022

Study information

• Verified date: May 2024
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2022
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER-2 Positive Breast Cancer

Intervention

Drug:
• Trastuzumab
neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo	Candiolo	TO
Italy	Istituto Nazionale per La Ricerca sul Cancro (IST)	Genoa	Ge
Italy	Ospedale Sacro Cuore - Don Calabria - Oncologia Medica	Negrar	VR
Italy	Ospedale S. Maria della Misericordia - Oncologia Medica	Perugia	PG
Italy	Ospedale Mauriziano Umberto I - Ginecologia Oncologica	Torino	TO
Italy	Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica	Torino	To

Sponsors (1)

Lead Sponsor	Collaborator
Lucia Del Mastro,MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response		at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
Secondary	safety and tolerability	safety and tolerability will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Toxicity grade is defined by the NCI Common Toxicity Criteria (CTC) Adverse Event (AE) v 3.0	one year
Secondary	cardiotoxicity		one year
Secondary	disease free survival		one year
Secondary	overall survival		one year
Secondary	rate of conversion from radical to conservative surgery		definitive surgery
Secondary	potential biomarkers of trastuzumab resistance		one year