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

Phase 2

Completed

• Conditions: HER-2 Positive Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01340430
• Lead Sponsor: Lucia Del Mastro,MD

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2015-12
• Study Completion: 2022-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEC-paclitaxel-trastuzumab	Trastuzumab	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

Primary Outcome Measures

Name	Time	Method
pathologic complete response	at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab

Secondary Outcome Measures

Name	Time	Method
safety and tolerability	one year	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
overall survival	one year
rate of conversion from radical to conservative surgery	definitive surgery
disease free survival	one year
cardiotoxicity	one year
potential biomarkers of trastuzumab resistance	one year

Trial Locations

Locations (6)

Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica; 🇮🇹 Torino, To, Italy

Ospedale S. Maria della Misericordia - Oncologia Medica; 🇮🇹 Perugia, PG, Italy

Istituto Nazionale per La Ricerca sul Cancro (IST); 🇮🇹 Genoa, Ge, Italy

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo; 🇮🇹 Candiolo, TO, Italy

Ospedale Mauriziano Umberto I - Ginecologia Oncologica; 🇮🇹 Torino, TO, Italy

Ospedale Sacro Cuore - Don Calabria - Oncologia Medica; 🇮🇹 Negrar, VR, Italy